Publications by authors named "Amy L Lightner"

151 Publications

Early Initiation of Antitumor Necrosis Factor Therapy Reduces Postoperative Recurrence of Crohn's Disease Following Ileocecal Resection.

Inflamm Bowel Dis 2022 Jul 29. Epub 2022 Jul 29.

Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH, USA.

Background: Postoperative recurrence (POR) of Crohn's disease (CD) is common after surgical resection. We aimed to compare biologic type and timing for preventing POR in adult CD patients after ileocecal resection (ICR).

Methods: We performed a retrospective cohort study of CD patients who underwent an ICR at 2 medical centers. Recurrence was defined by endoscopy (≥ i2b Rutgeerts score) or radiography (active inflammation in neoterminal ileum) and stratified by type and timing of postoperative prophylactic biologic within 12 weeks following an ICR (none, tumor necrosis factor antagonists [anti-TNF], vedolizumab, and ustekinumab).

Results: We identified 1037 patients with CD who underwent an ICR. Of 278 (26%) who received postoperative prophylaxis, 80% were placed on an anti-TNF agent (n = 223) followed by ustekinumab (n = 28, 10%) and vedolizumab (n = 27, 10%). Prophylaxis was initiated in 35% within 4 weeks following an ICR and in 65% within 4 to 12 weeks. After adjusting for factors associated with POR, compared with no biologic prophylaxis, the initiation of an anti-TNF agent within 4 weeks following an ICR was associated with a reduction in POR (adjusted hazard ratio, 0.61; 95% CI, 0.40-0.93). Prophylaxis after 4 weeks following an ICR or with vedolizumab or ustekinumab was not associated with a reduction in POR compared with those who did not receive prophylaxis.

Conclusion: Early initiation of an anti-TNF agent within 4 weeks following an ICR was associated with a reduction in POR. Vedolizumab or ustekinumab, at any time following surgery, was not associated with a reduction in POR, although sample size was limited.
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http://dx.doi.org/10.1093/ibd/izac158DOI Listing
July 2022

CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease.

Gastroenterology 2022 Jul 3. Epub 2022 Jul 3.

Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio.

Background & Aims: End points to determine the efficacy and safety of medical therapies for Crohn's disease (CD) and ulcerative colitis (UC) are evolving. Given the heterogeneity in current outcome measures, harmonizing end points in a core outcome set for randomized controlled trials is a priority for drug development in inflammatory bowel disease.

Methods: Candidate outcome domains and outcome measures were generated from systematic literature reviews and patient engagement surveys and interviews. An iterative Delphi process was conducted to establish consensus: panelists anonymously voted on items using a 9-point Likert scale, and feedback was incorporated between rounds to refine statements. Consensus meetings were held to ratify the outcome domains and core outcome measures. Stakeholders were recruited internationally, and included gastroenterologists, colorectal surgeons, methodologists, and clinical trialists.

Results: A total of 235 patients and 53 experts participated. Patient-reported outcomes, quality of life, endoscopy, biomarkers, and safety were considered core domains; histopathology was an additional domain for UC. In CD, there was consensus to use the 2-item patient-reported outcomes (ie, abdominal pain and stool frequency), Crohn's Disease Activity Index, Simple Endoscopic Score for Crohn's Disease, C-reactive protein, fecal calprotectin, and co-primary end points of symptomatic remission and endoscopic response. In UC, there was consensus to use the 9-point Mayo Clinic Score, fecal urgency, Robarts Histopathology Index or Geboes Score, fecal calprotectin, and a composite primary end point including both symptomatic and endoscopic remission. Safety outcomes should be reported using the Medical Dictionary for Regulatory Activities.

Conclusions: This multidisciplinary collaboration involving patients and clinical experts has produced the first core outcome set that can be applied to randomized controlled trials of CD and UC.
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http://dx.doi.org/10.1053/j.gastro.2022.06.068DOI Listing
July 2022

A phase IB/IIA study of remestemcel-L, an allogeneic bone marrow-derived mesenchymal stem cell product, for the treatment of medically refractory ulcerative colitis: an interim analysis.

Colorectal Dis 2022 Jun 29. Epub 2022 Jun 29.

Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Aim: There have been no studies into the direct injection of mesenchymal stem cells (MSCs) for luminal ulcerative colitis (UC). Our aim was to investigate the efficacy of MSCs delivered locally via endoscopic delivery, as is done in the setting of perianal disease, to treat the local site of inflammation directly.

Method: A phase IB/IIA randomized control clinical trial of remestemcel-L, an ex vivo expanded allogeneic bone marrow-derived MSC product, at a dose of 150 million MSCs versus placebo (2:1 fashion) delivered via direct injection using a 23-gauge sclerotherapy needle at the time of colonoscopy was designed to assess the safety and efficacy of endoscopic delivery of MSCs for UC. The main outcome measures were adverse events, Mayo score and Mayo endoscopic severity score at 2 weeks, 6 weeks and 3 months post-MSC delivery.

Results: Six patients were enrolled and treated; four received MSCs and two placebo. All had been on prior anti-tumour necrosis factor or anti-integrin therapy. There were no adverse events related to MSCs. In the treatment group (n = 4), the Mayo endoscopic severity score decreased in all patients by 2 weeks after MSC delivery. At 3 months, all patients were extremely satisfied or satisfied with their MSC treatment based on the inflammatory bowel disease patient-reported treatment impact (IBD-PRTI), and treatment response was described as excellent or good in all patients. In the control group (n = 2), the Mayo endoscopic severity score did not increase as a result of being off alternative therapy. At 3 months, patients were dissatisfied according to the IBD-PRTI, and treatment response was poor or unchanged.

Conclusion: MSCs may offer a safe therapeutic option for the treatment of medically refractory UC. Early data suggest improved clinical and endoscopic scores by 2 weeks after MSC delivery.
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http://dx.doi.org/10.1111/codi.16239DOI Listing
June 2022

Intraabdominal septic complications after ileocolic resection increases risk for endoscopic and surgical postoperative Crohn's disease recurrence.

J Crohns Colitis 2022 Jun 15. Epub 2022 Jun 15.

Cleveland Clinic Department of Gastroenterology, Hepatology, and Nutrition.

Background: Postoperative recurrence (POR) of Crohn's disease following ileocolonic resection is common. The impact of immediate postoperative intraabdominal septic complications (IASC) on endoscopic and surgical recurrence has not been elucidated.

Aims: To evaluate if IASC is associated with increased risk for endoscopic and surgical POR.

Methods: Retrospective study of adult Crohn's disease patients undergoing ileocolonic resection with primary anastomosis between 2009 and 2020. IASC was defined as anastomotic leak or intraabdominal abscess within 90 days of date of surgery. Multivariable logistic and Cox proportional hazard modeling were performed to assess impact of IASC on endoscopic POR (modified Rutgeerts' score ≥i2b) at index postoperative ileocolonoscopy and long-term surgical recurrence.

Results: 535 Crohn's disease patients (median age 35 years, 22.1% active smokers, 35.7% ≥1 prior resection) had an ileocolonic resection with primary anastomosis. A minority of patients (N=47; 8.8%) developed postoperative IASC. 422 (78.9%) patients had ≥1 postoperative ileocolonoscopy, of whom 163 (38.6%) developed endoscopic POR. After adjusting for other risk factors for postoperative recurrence, postoperative IASC was associated with significantly greater odds (aOR: 2.45 [1.23-4.97]; p=0.01) and decreased time (aHR: 1.60 [1.04-2.45]; p=0.03) to endoscopic POR. Furthermore, IASC was associated with increased risk (aOR: 2.3; [1.04-4.87] p=0.03) and decreased survival-free time (aHR:2.53 [1.31-4.87]; p=0.006) for surgical recurrence.

Conclusion: IASC is associated with an increased risk for endoscopic and surgical POR of Crohn's disease. Preoperative optimization to prevent IASC, in addition to postoperative biologic prophylaxis, may help reduce risk for endoscopic and surgical POR.
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http://dx.doi.org/10.1093/ecco-jcc/jjac078DOI Listing
June 2022

The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for Ostomy Surgery.

Dis Colon Rectum 2022 May 24. Epub 2022 May 24.

Department of Surgery, University of Cincinnati, Cincinnati, Ohio.

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http://dx.doi.org/10.1097/DCR.0000000000002498DOI Listing
May 2022

Surgical Management of Crohn's Disease.

Gastroenterol Clin North Am 2022 06 27;51(2):353-367. Epub 2022 Apr 27.

Department of Colorectal Surgery, Digestive Disease Surgical Institute, Cleveland Clinic, Cleveland, OH, USA; Center for Regenerative Medicine and Surgery, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, USA; Digestive Disease and Surgery Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, USA; Lerner Research Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, USA; Center for Immunotherapy, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, USA. Electronic address:

Treatment of Crohn's disease (CD) focuses on providing acceptable quality of life for the affected individual by optimizing medical therapy, endoscopic procedures, and surgical intervention. Biologics have changed the medical management of moderate to severe CD. However, despite their introduction, the need for surgical resection in CD has not drastically changed, with two-thirds of the patients still requiring an intestinal resection. Patient outcomes are optimized by focusing on preoperative management and intraoperative technical aspects to maximize bowel preservation. This article reviews some of the important principles of Crohn's surgery to help guide surgeons when approaching this challenging patient population.
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http://dx.doi.org/10.1016/j.gtc.2021.12.010DOI Listing
June 2022

Pouch volvulus-why adhesions are not always the enemy.

Colorectal Dis 2022 May 18. Epub 2022 May 18.

Department of Colon and Rectal Surgery, Cleveland Clinic, Cleveland, Ohio, USA.

Aim: Minimally invasive approaches to proctocolectomy with ileal pouch anal anastomosis have become the standard of care with one benefit being the reduced risk of adhesion-related complications. However, a lack of pouch adherence to the pelvis can lead to increased mobility as well as volvulization, placing pouch viability at risk. We aimed to describe our institutional experience with pouch volvulus.

Methods: Patients who presented with pouch volvulus from 1983 to 2020 were identified through a search of our pelvic pouch registry and enterprise-wide electronic medical record. Pouch volvulus was defined as a reducible rotation of the J-pouch on its mesenteric axis with evidence of a properly oriented ileo-anal anastomosis. Patients with 'twisted pouches' were excluded.

Results: In total, 5760 patients underwent ileal pouch anal anastomosis from 1983 to 2020. Six patients (five women) were identified with a diagnosis of 'pouch volvulus' consistent with our definition. The six pouches were constructed utilizing laparoscopic techniques and the mean time from construction to volvulus was 2.36 years. All patients underwent urgent surgery, with a paucity of adhesions noted in five. Reduction and pouch pexy was performed in three and pouch excision in three, with immediate pouch reconstruction in two and end ileostomy creation in one. At a median follow-up of 9 months, pouch survival was 50%.

Conclusions: Pelvic pouches constructed using minimally invasive techniques may be at risk of volvulus due to reduced adhesion development. A high index of suspicion is warranted in pouch patients with obstructive symptomatology. CT imaging may be diagnostic, and prompt surgical intervention may facilitate pouch salvage.
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http://dx.doi.org/10.1111/codi.16195DOI Listing
May 2022

Adipose tissue-derived mesenchymal stem cells' acellular product extracellular vesicles as a potential therapy for Crohn's disease.

J Cell Physiol 2022 07 6;237(7):3001-3011. Epub 2022 May 6.

Department of Colorectal Surgery, Digestive Disease Surgical Institute, Cleveland Clinic, Cleveland, Ohio, USA.

The breakdown of gastrointestinal tract immune homeostasis leads to Crohn's disease (CD). Mesenchymal stem cells (MSCs) have demonstrated clinical efficacy in treating CD in clinical trials, but there is little known about the mechanism of healing. Considering the critical roles of macrophage polarization in CD and immunomodulatory properties of MSCs, we sought to decipher the interaction between adipose-derived MSCs and macrophages, including their cytokine production, regulation of differentiation, and pro-/anti-inflammatory function. RNA extraction and next generation sequencing was performed in adipose tissue from healthy control patients' mesentery (n = 3) and CD mesentery (n = 3). Infiltrated macrophage activation in the CD mesentery was tested, MSCs and extracellular vesicles (EVs) were isolated to compare the regulation of macrophage differentiation, cytokines production, and self-renewal capacities in vitro. CD patients' mesentery has increased M1 macrophage polarization and elevated activation. MSCs and their derived EVs, isolated from inflamed Crohn's mesentery, leads to a rapid differentiation of monocytes to a M1-like polarized phenotype. Conversely, MSCs and their derived EVs from healthy, non-Crohn's patients results in monocyte polarization into a M2 phenotype; this is seen regardless of the adipose source of MSCs (subcutaneous fat, omentum, normal mesentery). EVs derived from MSCs have the ability to regulate macrophage differentiation. Healthy MSCs and their associated EVs have the ability to drive monocytes to a M2 subset, effectively reversing an inflammatory phenotype. This mechanism supports why MSCs may be an effective therapeutic in CD and highlights EVs as a novel therapeutic for further exploration.
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http://dx.doi.org/10.1002/jcp.30756DOI Listing
July 2022

Management of Fistulas in Patients With Crohn's Disease.

Authors:
Amy L Lightner

Gastroenterol Hepatol (N Y) 2021 Nov;17(11):533-535

Director, Center for Regenerative Medicine and Surgery Associate Professor of Colorectal Surgery Digestive Disease Institute Associate Professor of Inflammation and Immunity Lerner Research Institute Cleveland Clinic Cleveland, Ohio.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9021165PMC
November 2021

New insights on the surgical management of ulcerative colitis in the 21st century.

Lancet Gastroenterol Hepatol 2022 07 29;7(7):679-688. Epub 2022 Mar 29.

Department of Surgery, Amsterdam Univerity Medical Centers, Location AMC, Amsterdam, Netherlands; IBD Unit, Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.

Despite substantial advances in medical therapy since 2005 that have led to the approval and increased use of novel biological agents and small molecules, colectomy is still a therapeutic option for some patients with ulcerative colitis. In the biological era (ie, after the approval of biological agents for ulcerative colitis), improved control of disease activity has led to a trend of decreasing colectomy rates for refractory disease. Consequently, indications for colectomy for dysplasia and colorectal cancer seem to be increasing. Advances have not only been made in surgical techniques, but also in multidisciplinary approaches, the timing of surgery, and in medical management before and after surgery. This Review discusses surgical indications in patients with ulcerative colitis in relation to current medical therapy, management in the acute setting, indications for staged procedures, new techniques such as transanal surgery and robotics, and surgical alternatives to ileal pouch-anal anastomosis. A multidisciplinary approach including surgeons, gastroenterologists, pathologists, radiologists, and clinical nutritionists is essential to improving patient outcomes in different clinical scenarios of ulcerative colitis management in the 21st century.
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http://dx.doi.org/10.1016/S2468-1253(22)00001-2DOI Listing
July 2022

Venous Thromboembolism in Admitted Patients with Inflammatory Bowel Disease: An Enterprise-Wide Experience of 86,000 Hospital Encounters.

Dis Colon Rectum 2022 Mar 24. Epub 2022 Mar 24.

Department of Colorectal Surgery, Digestive Disease Surgical Institute, Cleveland Clinic, Cleveland, Ohio.

Background: Recommendations regarding venous thromboembolism prophylaxis in admitted inflammatory bowel disease patients continues to evolve.

Objective: The objective was to determine the 90-day rate and risk factors of deep venous thromboembolism and pulmonary embolism in admitted medical and surgical IBD patient cohorts.

Design: This was a retrospective review.

Setting: The study was conducted at a quaternary IBD referral center.

Patients: Adult patients (≥ 18 years) with a known diagnosis of either ulcerative colitis or Crohn's disease who had an inpatient hospital admission for IBD between January 1, 2002, and January 1, 2020, were included.

Main Outcome Measure: The primary measures were 90-day rate of deep venous thromboembolism and pulmonary embolism among admitted patients.

Results: A total of 86,276 hospital admissions from 16,551 patients with IBD occurred between January 1, 2002, and January 1, 2020. A total of 35,992 (41.7%) were given subcutaneous heparin for venous thromboembolism prophylaxis, and 8,188 (9.49%) were given enoxaparin for venous thromboembolism prophylaxis during the inpatient hospital admission. From the date of hospital admission, the 90-day rate of deep venous thromboembolism was 4.3% (n = 3,664); of these 1,731 (47%) were diagnosed during the admission and 1,933 (53%) were diagnosed after discharge. From the date of hospital admission, the 90-day rate of pulmonary embolism was 2.4% (n = 2,040); of these 960 (47%) were diagnosed during the admission and 1,080 (53%) were diagnosed after discharge.

Limitations: The study was retrospective and unmeasured severity of disease.

Conclusion: Patients admitted for IBD had a 90-day deep venous thromboembolism and pulmonary embolism event rate of 4.3% and 2.4%, respectively. Over half of the events occurred after discharge and VTE events were higher among medical than surgical IBD patients. See Video Abstract at http://links.lww.com/DCR/B947. (Pre-proofed version).
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http://dx.doi.org/10.1097/DCR.0000000000002338DOI Listing
March 2022

Classifying perianal fistulising Crohn's disease: an expert consensus to guide decision-making in daily practice and clinical trials.

Lancet Gastroenterol Hepatol 2022 06 21;7(6):576-584. Epub 2022 Mar 21.

Robin Phillips Fistula Research Unit, St Mark's Hospital and Academic Institute, London, UK; Department of Colorectal Surgery, St Mark's Hospital and Academic Institute, London, UK; Imperial College, London, UK.

Perianal fistulising Crohn's disease is an aggressive disease phenotype that can have a substantial detrimental impact on patients' quality of life. Current biological understanding of perianal fistulising Crohn's disease remains inadequate and previous classification systems have not provided clear guidance on therapy in clinical practice nor on defining patient cohorts within clinical trials. We propose a new classification system for perianal fistulising Crohn's disease that was developed through a modified nominal group technique expert consensus process. The classification identifies four groups of patients. Key elements include stratification according to disease severity as well as disease outcome; synchronisation of patient and clinician goals in decision making, with a proactive, combined medical and surgical approach, on a treat to patient goal basis; and identification of indications for curative fistula treatment, diverting ostomy, and proctectomy. The new classification retains an element of flexibility, in which patients can cycle through different classes over time. Furthermore, with each specific class comes a paired treatment strategy suggestion and description of clinical trial suitability. The proposed classification system is the first of its kind and is an important step towards tailored standardisation of clinical practice and research in patients with perianal fistulising Crohn's disease.
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http://dx.doi.org/10.1016/S2468-1253(22)00007-3DOI Listing
June 2022

Mild neoterminal ileal post-operative recurrence of Crohn's disease conveys higher risk for severe endoscopic disease progression than isolated anastomotic lesions.

Aliment Pharmacol Ther 2022 05 14;55(9):1139-1150. Epub 2022 Mar 14.

Cleveland Clinic Department of Gastroenterology, Hepatology, and Nutrition, Cleveland, OH, USA.

There are conflicting data assessing the impact of isolated post-operative anastomotic inflammation on future disease progression. The aim of this study was to determine the relative risk of severe disease progression in post-operative Crohn's disease (CD) patients with isolated anastomotic disease.

Methods: Retrospective cohort study of adult CD patients undergoing ileocolonic resection between 2009 and 2020. Patients with a post-operative ileocolonoscopy ≤18 months from surgery and ≥1 subsequent ileocolonoscopy were included. Disease activity was assessed using the modified Rutgeerts' score (RS). Primary outcome was severe endoscopic progression, defined as i3 or i4 disease, on immediate subsequent ileocolonoscopy and during entire post-operative follow-up. Secondary outcome was surgical recurrence.

Results: One hundred and ninety-nine CD patients had an ileocolonoscopy ≤18 months from surgery, index RS of i0-i2b and ≥1 subsequent ileocolonoscopy. At index ileocolonoscopy, 34.7% had i0 disease, 16.1% i1, 24.6% i2a and 24.6% i2b. On multivariable logistic regression, i2b disease was associated with severe endoscopic progression compared to i0 or i1 (aOR 5.53; P < 0.001) and i2a disease patients (aOR 2.63; P = 0.03). However, i2a disease did not confer increased risk compared to i0 or i1 disease (P = 0.09). Furthermore, i2b patients experienced severe endoscopic progression significantly earlier than i0 or i1 disease (aHR 4.68; P < 0.001), whereas i2a disease did not differ from i0 or i1 disease (P = 0.25). Surgical recurrence was not associated with index RS i0-i2b (P = 0.86).

Conclusion: Post-operative ileal disease recurrence, not isolated anastomotic inflammation, confers increased risk for severe endoscopic disease progression. Location of CD recurrence may impact optimal management strategies.
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http://dx.doi.org/10.1111/apt.16804DOI Listing
May 2022

Cost-Effectiveness of Aspirin for Extended Venous Thromboembolism Prophylaxis After Major Surgery for Inflammatory Bowel Disease.

J Gastrointest Surg 2022 06 11;26(6):1275-1285. Epub 2022 Mar 11.

Department of Colorectal Surgery, Cleveland Clinic Foundation, 9500 Euclid Ave, A30, Cleveland, OH, 44195, USA.

Background And Purpose: Venous thromboembolism extended prophylaxis after inflammatory bowel disease surgery remains controversial. The purpose of this study was to evaluate if adopting an aspirin-based prophylaxis strategy may address current cost-effectiveness limitations.

Methods: A decision analysis model was used to compare costs and outcomes of a reference case patient undergoing inflammatory bowel disease-associated colorectal surgery considered for post-discharge thromboembolism prophylaxis. Low-dose aspirin was compared to an enoxaparin regimen as well as no prophylaxis. Source estimates were obtained from aggregated existing literature. Secondary analysis included out-of-pocket costs. A 10,000-simulation Monte Carlo probabilistic sensitivity analysis accounted for uncertainty in model estimates.

Results: An enoxaparin-based regimen compared to aspirin demonstrated an unfavorable incremental cost-effectiveness ratio of $908,268 per quality-adjusted life year. Sensitivity analysis supported this finding in > 75% of simulated cases; scenarios favoring enoxaparin included those with > 4% post-discharge event rates. Aspirin versus no prophylaxis demonstrated a favorable ratio of $106,601 per quality-adjusted life year. Findings were vulnerable to a post-discharge thromboembolism rate < 1%, aspirin-associated bleeding rate > 1%, median hospital costs of bleeding > 3 × , and decreased efficacy of aspirin (RR > 0.75). The average out-of-pocket cost of choosing an aspirin ePpx strategy increased by $54 per patient versus $708 per patient with enoxaparin.

Conclusions: Low-dose aspirin extended prophylaxis following inflammatory bowel disease surgery has a favorable cost-safety profile and may be an attractive alternative approach.
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http://dx.doi.org/10.1007/s11605-022-05287-zDOI Listing
June 2022

Association of cancer with comorbid inflammatory conditions and treatment in patients with Lynch syndrome.

World J Clin Oncol 2022 Jan;13(1):49-61

Department of Gastroenterology and Hepatology, Virginia Mason Franciscan Health, Seattle, WA 98101, United States.

Background: Individuals with Lynch syndrome (LS) and hereditary non-polyposis colorectal cancer (HNPCC) are at increased risk of both colorectal cancer and other cancers. The interplay between immunosuppression, a comorbid inflammatory condition (CID), and HNPCC on cancer risk is unclear.

Aim: To evaluate the impact of CIDs, and exposure to monoclonal antibodies and immunomodulators, on cancer risk in individuals with HNPCC.

Methods: Individuals prospectively followed in a hereditary cancer registry with LS/HNPCC with the diagnosis of inflammatory bowel disease or rheumatic disease were identified. We compared the proportion of patients with cancer in LS/HNPCC group with and without a CID. We also compared the proportion of patients who developed cancer following a CID diagnosis based upon exposure to immunosuppressive medications.

Results: A total of 21 patients with LS/HNPCC and a CID were compared to 43 patients with LS/HNPCC but no CID. Cancer occurred in 84.2% with a CID compared to 76.7% without a CID ( = 0.74) with no difference in age at first cancer diagnosis 45.5 ± 14.6 43.8 ± 7.1 years ( = 0.67). LS specific cancers were diagnosed in 52.4% with a CID 44.2% without a CID ( = 0.54). Nine of 21 (42.9%) patients were exposed to biologics or immunomodulators for the treatment of their CID. Cancer after diagnosis of CID was seen in 7 (77.8%) of exposed individuals 5 (41.7%) individuals unexposed to biologics/immunomodulators ( = 0.18). All 7 exposed compared to 3/5 unexposed developed a LS specific cancer. The exposed and unexposed groups were followed for a median 10 years and 8.5 years, respectively. The hazard ratio for cancer with medication exposure was 1.59 ( = 0.43, 95%CI: 0.5-5.1).

Conclusion: In patients with LS/HNPCC, the presence of a concurrent inflammatory condition, or use of immunosuppressive medication to treat the inflammatory condition, might not increase the rate of cancer occurrence in this limited study.
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http://dx.doi.org/10.5306/wjco.v13.i1.49DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8790302PMC
January 2022

Anorectal Strictures in Complex Perianal CD: How to Approach?

Clin Colon Rectal Surg 2022 Jan 17;35(1):44-50. Epub 2022 Jan 17.

Department of Gastroenterology, Digestive Disease Surgical Institute, Cleveland Clinic, Cleveland, Ohio.

Anorectal strictures are a notoriously difficult to treat phenotype of perianal Crohn's disease. Quality of life is diminished due to ongoing pain, incontinence, difficulty with stool evacuation, and recurrent medical and surgical treatments. Medical therapy is aimed at treating luminal disease and mucosal ulceration to prevent worsening of fibrosis. Clinical examination and endoscopic intervention can be used for serial dilations of strictures. Unfortunately, despite optimal medical therapy and endoscopic intervention with serial anal dilations, surgery with intestinal diversion or proctocolectomy may be required as part of the treatment algorithm in a significant proportion of patients.
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http://dx.doi.org/10.1055/s-0041-1740037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8763464PMC
January 2022

The Cumulative Incidence of Pouchitis in Pediatric Patients With Ulcerative Colitis.

Inflamm Bowel Dis 2022 Jan 18. Epub 2022 Jan 18.

Multidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Despite highly effective therapies, many children develop medically refractory ulcerative colitis (UC) and undergo proctocolectomy with ileal pouch-anal anastomosis (IPAA). We sought to determine the incidence, risk, and burden of pouchitis in the first 2 years following the final stage of IPAA in pediatric UC patients.

Methods: Within the IQVIA Legacy PharMetrics Adjudicated Claims Database, we identified pediatric patients with UC who underwent proctocolectomy with IPAA between January 1, 2007, and June 30, 2015. We utilized International Classification of Diseases-Ninth Revision-Clinical Modification or International Classification of Diseases-Tenth Revision-Clinical Modification codes to identify patients with UC and Current Procedural Terminology codes to identify colectomy and IPAA. Continuous variables were compared using t tests and Wilcoxon rank sum testing, while categorical variables were compared using chi-square testing.

Results: A total of 68 patients with an IPAA were identified. In the first 2 years following IPAA, the cumulative incidence of pouchitis was 54%. Patients with pouchitis required more outpatient visits in the first 2 years after IPAA (mean 21.8 vs 10.2; P = .006) and were more likely to be hospitalized compared with patients without pouchitis (46% vs 23%; P = .045). Patients with pouchitis also demonstrated higher mean total costs in year 1 and year 2 ($27 489 vs $8032 [P = .001] and $27 699 vs $6058 [P = .003], respectively).

Conclusions: Our findings confirm the high incidence of pouchitis demonstrated in earlier single-center studies of pediatric patients undergoing proctocolectomy with IPAA for UC. Identification of risk factors for pouchitis would be useful to optimize early intervention.
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http://dx.doi.org/10.1093/ibd/izab320DOI Listing
January 2022

Predicting Risk of Surgery in Patients With Small Bowel Crohn's Disease Strictures Using Computed Tomography and Magnetic Resonance Enterography.

Inflamm Bowel Dis 2022 Jan 15. Epub 2022 Jan 15.

Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.

Background: We aimed to determine if patient symptoms and computed tomography enterography (CTE) and magnetic resonance enterography (MRE) imaging findings can be used to predict near-term risk of surgery in patients with small bowel Crohn's disease (CD).

Methods: CD patients with small bowel strictures undergoing serial CTE or MRE were retrospectively identified. Strictures were defined by luminal narrowing, bowel wall thickening, and unequivocal proximal small bowel dilation. Harvey-Bradshaw index (HBI) was recorded. Stricture observations and measurements were performed on baseline CTE or MRE and compared to with prior and subsequent scans. Patients were divided into those who underwent surgery within 2 years and those who did not. LASSO (least absolute shrinkage and selection operator) regression models were trained and validated using 5-fold cross-validation.

Results: Eighty-five patients (43.7 ± 15.3 years of age at baseline scan, majority male [57.6%]) had 137 small bowel strictures. Surgery was performed in 26 patients within 2 years from baseline CTE or MRE. In univariate analysis of patients with prior exams, development of stricture on the baseline exam was associated with near-term surgery (P = .006). A mathematical model using baseline features predicting surgery within 2 years included an HBI of 5 to 7 (odds ratio [OR], 1.7 × 105; P = .057), an HBI of 8 to 16 (OR, 3.1 × 105; P = .054), anastomotic stricture (OR, 0.002; P = .091), bowel wall thickness (OR, 4.7; P = .064), penetrating behavior (OR, 3.1 × 103; P = .096), and newly developed stricture (OR: 7.2 × 107; P = .062). This model demonstrated sensitivity of 67% and specificity of 73% (area under the curve, 0.62).

Conclusions: CTE or MRE imaging findings in combination with HBI can potentially predict which patients will require surgery within 2 years.
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http://dx.doi.org/10.1093/ibd/izab332DOI Listing
January 2022

Appropriateness of Medical and Surgical Treatments for Chronic Pouchitis Using RAND/UCLA Appropriateness Methodology.

Dig Dis Sci 2022 Jan 10. Epub 2022 Jan 10.

The BRIDGe Group, Cedars Sinai Medical Center, Los Angeles, CA, USA.

Background And Aims: The treatment of chronic pouchitis remains a challenge due to the paucity of high-quality studies. We aimed to provide guidance for clinicians on the appropriateness of medical and surgical treatments in chronic pouchitis.

Methods: Appropriateness of medical and surgical treatments in patients with chronic pouchitis was considered in 16 scenarios incorporating presence/absence of four variables: pouchitis symptoms, response to antibiotics, significant prepouch ileitis, and Crohn's disease (CD)-like complications (i.e., stricture or fistula). Appropriateness of permanent ileostomy in patients refractory to medical treatments was considered in eight additional scenarios. Using the RAND/UCLA appropriateness method, international IBD expert panelists rated appropriateness of treatments in each scenario on a 1-9 scale.

Results: Chronic antibiotic therapy was rated appropriate only in asymptomatic antibiotic-dependent patients with no CD-like complications and inappropriate in all other scenarios. Ileal-release budesonide was rated appropriate in 6/16 scenarios including patients with significant prepouch ileitis but no CD-like complications. Probiotics were considered either inappropriate (14/16) or uncertain (2/16). Biologic therapy was considered appropriate in most scenarios (14/16) and uncertain in situations where significant prepouch ileitis or CD-like complications were absent (2/16). In patients who are refractory to all medications, permanent ileostomy was considered appropriate in all scenarios (7/8) except in asymptomatic patients with no CD-like complications.

Conclusions: In the presence of significant prepouch ileitis or CD-like complications, chronic antibiotics and probiotics are inappropriate. Biologics are appropriate in all patients except in asymptomatic patients with no evidence of complications. Permanent ileostomy is appropriate in most medically refractory patients.
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http://dx.doi.org/10.1007/s10620-021-07362-yDOI Listing
January 2022

Timing and outcome of right- vs left-sided colonic anastomotic leaks: Is there a difference?

Am J Surg 2022 03 20;223(3):493-495. Epub 2021 Dec 20.

Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address:

Background: Anastomotic leaks (AL) contribute to postoperative mortality, prolonged hospitalization, and increased health care costs. While left-sided AL (LAL) are well described in the literature, there is a paucity of studies on outcomes and management of right-sided AL (RAL). This study aimed to compare the timing of RAL versus LAL, and the variable diagnosis, management and outcomes of RAL versus LAL. We hypothesized that the timing of RAL may be later compared to LAL and may result in worse overall outcomes.

Methods: Patients who underwent curative intent surgery for neoplastic disease from January 1995 to December 2015 were included. Patients that underwent an anastomosis below the peritoneal reflection, neoadjuvant treatment, fecal diversion, previous colectomy/anastomosis, multiple anastomoses, and patients with inflammatory bowel disease or hereditary colorectal cancer syndromes were excluded. Patient demographics, neoplastic data, operative data, time to AL, methods utilized for diagnosis of AL, and management of AL were collected. The primary endpoint was timing of AL, and secondary endpoints were management and outcome based on RAL versus LAL. RAL and LAL were analyzed and compared using Chi-squared and categorical variables were expressed as number (percentage) and continuous variables expressed as median (interquartile range).

Results: A total of 2223 patients underwent oncologic resection for colonic neoplasia (1457 right sided and 766 left sided anastomoses). 67% of patients were male and median age was 69 years (range, 34-91). There were 48 total AL events (2.16%): 26 RAL (1.78%) and 22 LAL (2.87%). There was no statistical difference in leak rates between RAL and LAL and no difference in time to diagnosis or management (Table 1). RAL had significantly decreased operative time (p = 0.016), decreased intraoperative blood loss (p = 0.002), and increased diagnosis by CT/plain radiograph (p = 0.04). All patients that underwent surgery for leak had some form of fecal diversion performed. Morbidity and mortality were comparable between groups (p = 0.70; p = 1.0).

Conclusions: This study found overall very low AL rates with comparable timing of RAL and LAL, and no difference in management or outcome of RAL vs. LAL. These findings are informative for patient and surgeon expectations before and after surgery and when AL is suspected.
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http://dx.doi.org/10.1016/j.amjsurg.2021.12.019DOI Listing
March 2022

Test Characteristics of Cross-sectional Imaging and Concordance With Endoscopy in Postoperative Crohn's Disease.

Clin Gastroenterol Hepatol 2021 Dec 27. Epub 2021 Dec 27.

Cleveland Clinic Department of Gastroenterology, Hepatology, and Nutrition, Cleveland, Ohio. Electronic address:

Background & Aims: Postoperative Crohn's disease (CD) surveillance relies on endoscopic monitoring. The role of cross-sectional imaging is less clear. We evaluated the concordance of cross-sectional enterography with endoscopic recurrence and the predictive ability of radiography for future CD postoperative recurrence.

Methods: We performed a multi-institution retrospective cohort study of postoperative adult patients with CD who underwent ileocolonoscopy and cross-sectional enterography within 90 days of each other following ileocecal resection. Imaging studies were interpreted by blinded, expert CD radiologists. Patients were categorized by presence of endoscopic postoperative recurrence (E+) (modified Rutgeerts' score ≥i2b) or radiographic disease activity (R+) and grouped by concordance status.

Results: A total of 216 patients with CD with paired ileocolonoscopy and imaging were included. A majority (54.2%) exhibited concordance (34.7% E+/R+; 19.4% E-/R-) between studies. The plurality (41.7%; n = 90) were E-/R+ discordant. Imaging was highly sensitive (89.3%), with low specificity (31.8%), in detecting endoscopic postoperative recurrence. Intestinal wall thickening, luminal narrowing, mural hyper-enhancement, and length of disease on imaging were associated with endoscopic recurrence (all P < .01). Radiographic disease severity was associated with increasing Rutgeerts' score (P < .001). E-/R+ patients experienced more rapid subsequent endoscopic recurrence (hazard ratio, 4.16; P = .033) and increased rates of subsequent endoscopic (43.8% vs 22.7%) and surgical recurrence (20% vs 9.5%) than E-/R- patients (median follow-up, 4.5 years).

Conclusions: Cross-sectional imaging is highly sensitive, but poorly specific, in detecting endoscopic disease activity and postoperative recurrence. Advanced radiographic disease correlates with endoscopic severity. Patients with radiographic activity in the absence of endoscopic recurrence may be at increased risk for future recurrence, and closer monitoring should be considered.
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http://dx.doi.org/10.1016/j.cgh.2021.12.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9234099PMC
December 2021

Short- and Long-term Outcomes of Ileal Pouch Anal Anastomosis Construction in Obese Patients With Ulcerative Colitis.

Dis Colon Rectum 2022 Aug 5;65(8):e782-e789. Epub 2022 Jul 5.

Cleveland Clinic Foundation, Digestive Disease and Surgery Institute, Department of Colorectal Surgery, Cleveland, Ohio.

Background: Obese patients are traditionally considered difficult pouch candidates because of the potential for intraoperative technical difficulty and increased postoperative complications.

Objective: The purpose of this study was to compare the outcomes of obese versus nonobese patients with ulcerative colitis undergoing an IPAA.

Design: This is a retrospectively, propensity score-matched, prospectively collected cohort study.

Setting: This study was conducted at an IBD quaternary referral center.

Patients: Patients with ulcerative colitis undergoing IPAA (1990-2018) were included. Obesity was defined as a BMI ≥30 kg/m 2 .

Main Outcome Measures: The primary measures included 30-day complications, long-term anastomotic leak, and pouch failure rate (excision, permanent diversion, revision).

Results: Of 3300 patients, 631 (19.1%) were obese (median BMI = 32.4 kg/m 2 ). On univariate analysis, obese patients were more likely to be >50 years old (32.5% versus 22.7%, p < 0.001), ASA class 3 (41.7% versus 27.7%, p < 0.001), have diabetes (8.1% versus 3.3%, p < 0.001), and have had surgery in the biologic era (72.4% versus 66.2%, p = 0.003); they were less likely to have received preoperative steroids (31.2% versus 37.4%, p = 0.004). After a median follow-up of 7 years, 66.7% had completed at least 1 quality-of-life survey. Pouch survival in the matched sample was 99.2% (99.8% nonobese versus 95.4% obese, p = 0.002). After matching and controlling for confounding variables, worse clinical outcomes associated with obesity included global quality of life (relative risk, -0.71; p = 0.002) and long-term pouch failure (HR, 4.24; p = 0.007). Obesity was also independently associated with an additional 27 minutes of operating time ( p < 0.001). There was no association of obesity with the likelihood of developing a postoperative complication, length of stay, or pouch leak.

Conclusion: Restorative ileoanal pouch surgery in obese patients with ulcerative colitis is associated with a relatively decreased quality of life and increased risk of long-term pouch failure compared with nonobese patients. Obese patients may benefit from focused counseling about these risks before undergoing restorative pouch surgery. See Video Abstract at http://links.lww.com/DCR/B873 .

Resultados A Corto Y Largo Plazo En La Realizacin Del Reservorio Ileal En Pacientes Obesos Con Colitis Ulcerosa: ANTECEDENTES:Habitualmente se considera a los obesos como pacientes difíciles para la realización de un reservorio ileal, debido a su alta probabilidad de presentar dificultades técnicas intraoperatoria y aumento de las complicaciones posoperatorias.OBJETIVO:El propósito de este estudio fue comparar los resultados de pacientes con colitis ulcerosa obesos versus no obesos sometidos a un reservorio ileal y anastomosis anal (IPAA).DISEÑO:Este es un estudio de cohorte recopilado prospectivamente, retrospectivo, emparejado por puntajes de propensión.AJUSTE:Este estudio se llevó a cabo en un centro de referencia de cuarto nivel para enfermedades inflamatorias del intestino.PACIENTES:Se incluyeron pacientes con colitis ulcerosa sometidos a un reservorio ileal y anastomosis anal (1990-2018). Obesidad definida como un IMC ≥ 30 kg/m2.PRINCIPALES RESULTADO MEDIDOS:Los principales resultados medidos incluyeron complicaciones a los 30 días, fuga anastomótica a largo plazo y tasa de falla del reservorio ileal (escisión, derivación permanente, revisión).RESULTADOS:De 3.300 pacientes, 631 (19,1%) eran obesos (mediana de IMC = 32,4 kg/m2). En el análisis univariado, los pacientes obesos tenían más probabilidades de ser > 50 años (32,5% frente a 22,7%, p < 0,001), clase ASA 3 (41,7% frente a 27,7%, p < 0,001), tener diabetes (8,1% frente a 3,3%, p < 0,001), haberse sometido a cirugía en la era biológica (72,4% frente a 66,2%, p = 0,003), y tenían menos probabilidades de haber recibido esteroides preoperatorios (31,2% frente a 37,4%, p = 0,004). Después de una mediana de seguimiento de 7 años, el 66,7% había completado al menos una encuesta de calidad de vida. La supervivencia de la bolsa en la muestra emparejada fue del 99,2% (99,8% no obesos versus 95,4% obesos, p = 0,002). Después de emparejar y controlar las variables de confusión, los peores resultados clínicos asociados con la obesidad incluyeron la calidad de vida global (RR = -0,71, p = 0,002) y el fracaso de la bolsa a largo plazo (HR = 4,24, p = 0,007). La obesidad también se asoció de forma independiente con 27 minutos adicionales de tiempo quirúrgico ( p < 0,001). No hubo asociación de la obesidad con la probabilidad de desarrollar una complicación posoperatoria, la duración de la estadía o la fuga de la bolsa.CONCLUSIÓNES:La cirugía restauradora del reservorio ileoanal en pacientes obesos con colitis ulcerosa se asocia a una disminución relativa de la calidad de vida y un mayor riesgo de falla del reservorio a largo plazo en comparación con los pacientes no obesos. Los pacientes obesos pueden beneficiarse de un asesoramiento centrado en estos riesgos antes de someterse a una cirugía restauradoracon reservorio ileal y anastomosis anal. Consulte Video Resumen en http://links.lww.com/DCR/B873 . (Traducción-Dr. Rodrigo Azolas ).
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August 2022

Mesenteric Excision and Exclusion for Ileocolic Crohn's Disease: Feasibility and Safety of an Innovative, Combined Surgical Approach With Extended Mesenteric Excision and Kono-S Anastomosis.

Dis Colon Rectum 2022 01;65(1):e5-e13

Department of Colon & Rectal Surgery, Cleveland Clinic, Cleveland, Ohio.

Introduction: Ileocolic resection for Crohn's disease traditionally does not include a high ligation of the ileocolic pedicle, and most commonly is performed with a stapled side-to-side ileocolic anastomosis. The mesentery has recently been implicated in the pathophysiology of Crohn's disease. Two techniques have been developed and are associated with reduced postoperative recurrence: the Kono-S anastomosis that excludes diseased mesentery and extended mesenteric excision that resects diseased mesentery. We aimed to assess the technical feasibility and safety of a novel combination of techniques: mesenteric excision and exclusion.

Techniques: This initial report is a single-center descriptive study of consecutive adults who underwent mesenteric excision and exclusion for primary or recurrent ileocolic Crohn's disease from September 2020 to June 2021. Medication exposure and endoscopic balloon dilation before surgery were recorded. Phenotype was classified using the Montreal Classification. Thirty-day outcomes were reported. A video of the mesenteric excision and exclusion including the Kono-S anastomosis is presented.

Results: Twenty-two patients with ileocolic Crohn's disease underwent mesenteric excision and exclusion: 100% had strictures, 59% had fistulas, 81% were on biologics, and 27% had previous ileocolic resection(s). Seventy-two percent underwent laparoscopic procedures, a mesenteric defect was closed in 86%, omental flaps were fashioned in 77%, and 3 patients were diverted. Median operative time was 175 minutes. Median postoperative stay was 4 days. At 30 days, there were 2 readmissions for reintervention: 1 seton placement and 1 percutaneous drainage of a sterile collection. There were no cases of intra-abdominal sepsis or anastomotic leak.

Conclusions: Mesenteric excision and exclusion represents an innovative, progressive, and promising approach that appears to be highly feasible and safe. Further study is warranted to determine if mesenteric excision and exclusion is associated with reduced postoperative recurrence of ileocolic Crohn's disease.
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http://dx.doi.org/10.1097/DCR.0000000000002287DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9148419PMC
January 2022

Expert Commentary on Postoperative Evaluation and Management of Portomesenteric Venous Thrombosis in Patients With Inflammatory Bowel Disease.

Authors:
Amy L Lightner

Dis Colon Rectum 2022 01;65(1):14-15

Department of Colorectal Surgery, Cleveland Clinic, Digestive Disease and Surgery Institute, Cleveland, Ohio.

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http://dx.doi.org/10.1097/DCR.0000000000002321DOI Listing
January 2022

Gracilis Flap Repair for Reoperative Rectovaginal Fistula.

Dis Colon Rectum 2021 Oct 25. Epub 2021 Oct 25.

Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio.

Background: Surgical treatment of recurrent rectovaginal fistulas is notoriously difficult. Placement of the gracilis muscle between the vagina and anus is an advanced technique used to close persistent fistulas. We have utilized this procedure for recalcitrant fistulas and hypothesized that a gracilis interposition would offer a good treatment option for patients with refractory rectovaginal fistulas, regardless of underlying etiology.

Objective: Investigate healing rates of gracilis interposition in patients with refractory rectovaginal fistulas.

Design: Following institutional review board approval, a retrospective review of all adult female patients with a diagnosis of rectovaginal fistula between January 2009 to August 2020 was performed; those who underwent gracilis interposition for definitive fistula closure were included for analysis.

Setting: Colorectal surgery department at a tertiary center in United States.

Patients: All adult female patients with a diagnosis of a rectovaginal fistula who underwent gracilis interposition for definitive closure.

Main Outcome Measures: Patient demographics, etiology of rectovaginal fistula, previous surgical intervention, presence of intestinal diversion, operative details, 30-day morbidity, recurrence of fistula, and time to recurrence. Fistula closure was defined as lack of clinical symptoms following stoma closure, negative fistula detection on gastrograffin enema and absence of an internal opening at exam under anesthesia.

Results: Twenty-two patients were included who had a median age of 43 years (range 19-64 years) and median body mass index of 31 kg/m2 (range 22-51). Median time between prior attempted surgical repair and gracilis surgery was 7 months (range 3-17). The number of previously attempted repairs were: 1-2 (n=8), 3-4 (n=9), and > 4 (n=5). The most recent attempted surgical repair was rectal advancement flap (n=7), transperineal +/- Martius flap (n=4), episioproctotomy (n=3), transvaginal repair (n=2), and other (n=6). All patients had fecal diversion at the time of gracilis surgery. Thirty day postoperative surgical site infection at the graft/donor site was 32% (n=7). At a median follow-up of 22 months (range 2-62), fistula closure was 59% (n=13). Gracilis interposition was successful in all inflammatory bowel disease patients.

Limitations: Retrospective nature of the data.

Conclusions: Gracilis interposition is an effective operative technique for re-operative rectovaginal fistula closure. Patients should be counseled regarding the possibility of graft/donor site infection. See Video Abstract at http://links.lww.com/DCR/B763 .
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October 2021
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