Publications by authors named "Mihai Emil Căpîlna"

9 Publications

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Laterally extended parametrectomy.

Obstet Gynecol Sci 2021 May 25. Epub 2021 May 25.

Department of Infectious Diseases and Epidemiology, County Hospital, Brașov, Romania.

Objective: To describe the laterally extended parametrectomy (LEP) surgical technique, emphasizing the main challenges of the procedure.

Methods: LEP was designed as a more radical surgical procedure aiming to remove the entire parametrial tissue from the pelvic side wall. Its initial indications were for lymph node positive Stage Ib (current FIGO 2018 Stage IIIc) and Stage IIb cervical cancer. Currently, with most guidelines recommending definitive radiochemotherapy for these cases, initial LEP indications have become debatable. LEP is now mainly indicated for removing tumors involving the soft structures of the pelvic side wall during a pelvic exenteration, aiming to obtain lateral free margins. This expands the lateral borders of the dissection to not only the medial surface of internal iliac vessels, but also to the true limits of the pelvic side wall.

Results: During LEP, the parietal and visceral branches of the hypogastric vessels are divided at the entry and exit level of the pelvis. Consequently, the entire internal iliac system is excised, and no connective or lymphatic tissue remain on the pelvic side wall. The main technical challenges of LEP are caused by the difficulty in ligating large caliber vessels (internal iliac artery and vein) and the variable anatomic distribution of pelvic side wall veins.

Conclusion: LEP is a feasible technique for removing pelvic side wall recurrences, aiming to obtain surgical free margins.
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May 2021

Abdominal radical trachelectomy as fertility-sparing management for early stages of cervical cancer: Our experience in 18 cases.

Exp Ther Med 2021 Jul 23;22(1):674. Epub 2021 Apr 23.

First Obstetrics and Gynecology Clinic, 'George Emil Palade' University of Medicine, Pharmacy, Science and Technology, 540136 Târgu Mures, Romania.

The aim of this study was to present our experience of 18 cases of abdominal radical trachelectomy (ART), including 5 performed during pregnancy, analyzing patient selection, surgical complications, and oncological and obstetrical outcomes. This reproductive study included all early stage cervical cancer patients referred for ART at the 1st Obstetrics and Gynecology Clinic of the Emergency Clinical County Hospital Targu Mures, between 2010 and 2020. A total of 19 women were considered for ART, and only 1 case required conversion to radical hysterectomy. The patient mean age was 31 years (range 24-38 years), and 66.67% of the patients were nulliparous. Six women (33.33%) had stage IA2, 4 (22.22%) had stage IB1, 5 (27.78%) had stage IB2, and 4 (22.22%) had stage IB3 disease. One intraoperative complication occurred in this series, which consisted in both right ureteral and bladder injuries. Early postoperative complications were represented by urinary bladder dysfunction (33.33%), symptomatic pelvic lymphocele (11.1%), peritonitis (5.5%), and wound infection (5.5%). Late postoperative complications included cervical stenosis (5.5%), amenorrhea (11.1%), and pelvic abscess (5.5%). Four out of the 18 patients were operated on during pregnancy between 14 and 20 weeks; 2 of them gave birth at term, 2 of them aborted shortly after the surgery. Two vaginal recurrences were recorded; both were managed by hysterectomy, partial colpectomy and adjuvant chemoradiotherapy. At this moment, all patients are alive with no evidence of disease and 3 of them managed to conceive. In conclusion, ART should be recommended as a fertility-preserving procedure for women in their reproductive age. In selected cases, ART can be performed during pregnancy with encouraging results.
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July 2021

Prognostic Factors Associated with 5-Year Overall Survival in Cervical Cancer Patients Treated with Radical Hysterectomy Followed by Adjuvant Concurrent Chemoradiation Therapy at a Tertiary Care Center in Eastern Europe.

Diagnostics (Basel) 2021 Mar 22;11(3). Epub 2021 Mar 22.

First Obstetrics and Gynecology Clinic, University of Medicine, Pharmacy, Science and Technology "G.E. Palade" of Târgu Mureș, 540142 Târgu Mureș, Romania.

Background: This retrospective observational study aims to assess the 5-year overall survival and the prognostic significance of risk factors of patients who underwent radical hysterectomy followed by adjuvant concurrent chemoradiation therapy (CCRT) for FIGO stage IB1-IIB cervical cancer in a tertiary care center in Eastern Europe.

Methods: From January 2010 to February 2019, 222 patients with stage IB1-IIB cervical cancer were treated with radical hysterectomy followed by adjuvant CCRT in our institution. The baseline information consisting of demographic and clinicopathologic data, treatment choices, recurrences, and outcome information was collected and examined. The survival rates were illustrated using Kaplan-Meier curves and prognosis analyses were accomplished using Cox multivariate analyses.

Results: The 222 participants had a mean age of 51.2 years (28-76). The median follow-up time was 65.5 months (3-128). Tumor characteristics revealed FIGO stage (IB1 2.3%, IB2 35.1%, IB3 16.7%, IIA1 9%, IIA2 8.6%, IIB 28.4%) and the most encountered histologic cell type was squamous cell carcinoma (80.06%) followed by adenocarcinoma (11.3%). At the time of examination, 157 patients (70.07%) were alive, of which 135 (61%) were alive free of disease and 22 (9%) were alive with disease. The multivariate Cox regression analysis acknowledged stage IIB, parametrial involvement, and the presence of lymph node metastases as independent prognostic risk factors, significantly worsening the oncologic outcomes influencing the survival with a -value of 0.076, 0.0001, and 0.008, respectively. The 5-year overall survival was 69.9%.

Conclusions: Altogether, the study enhances the significance of prognostic risk factors on the 5-year overall survival of patients who underwent radical hysterectomy followed by adjuvant CCRT for FIGO stages IB1-IIB cervical cancer, allowing comparisons with other regions.
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March 2021

The Double Life-Saving Approach of Abdominal Radical Trachelectomy during Pregnancy for Early-Stage Cervical Cancer-An Overview of the Literature and Our Institutional Experience.

J Pers Med 2021 Jan 5;11(1). Epub 2021 Jan 5.

First Obstetrics and Gynecology Clinic, University of Medicine, Pharmacy, Science and Technology "G.E. Palade" of Târgu Mureș, Gheorghe Marinescu Street, Number 38, 540142 Târgu Mureș, Romania.

(1) Background: Cervical cancer is the most common type of cancer encountered during pregnancy, with a frequency of 0.8-1.5 cases per 10,000 births. It is a dire condition endangering patients' lives and pregnancy outcomes, and jeopardizing their fertility. However, there is a lack of current evidence and consensus regarding a standard surgical technique for pregnant patients who suffer from this condition during pregnancy. The study aims to comprehensively update all published data, evaluating the obstetrical and oncological results of pregnant patients who underwent abdominal radical trachelectomy during early stages of cervical cancer. (2) Methods: A literature search on the Medline, PubMed, and Google Scholar databases was performed, including all articles in question up to July 2020. This study presents an overview of the literature and our institutional experience. (3) Results: A total of 25 cases of abdominal radical trachelectomy were performed during pregnancy for early cervical cancer, including the five cases managed by the authors. Of these, 81% (19 patients) gave birth to live newborns through elective C-section, and 19% (6 patients) experienced miscarriage shortly after the procedure. None of the 25 patients (100%) reported disease recurrence. (4) Conclusions: The results of the current study were satisfactory. However, abdominal radical trachelectomy does not represent the current standard of care for cervical cancer during pregnancy, but it could play an important role if more evidence on its effectiveness will be provided.
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January 2021

Orthotopic continent urinary diversion (the Budapest pouch) in 10 steps.

Int J Gynecol Cancer 2020 11 12;30(11):1842-1843. Epub 2020 Aug 12.

First Obstetrics and Gynecology Clinic, "G.E Palade" University of Medicine, Pharmacy, Science and Technology, Târgu Mureș, Romania.

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November 2020

SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer.

Int J Gynecol Cancer 2020 09 11;30(9):1269-1277. Epub 2020 Aug 11.

Division of Gynecologic Oncology, 1st Department of Obstetrics and Gynecology, Alexandra Hospital, National and Kapodistrian University of Athens, Athens, Greece.

Background: Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse.

Methods: We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group.

Results: Mean age was 48.3 years (range; 23-83) while the mean BMI was 25.7 kg/m (range; 15-49). The risk of recurrence for patients who underwent minimally invasive surgery was twice as high as that in the open surgery group (HR, 2.07; 95% CI, 1.35 to 3.15; P=0.001). Similarly, the risk of death was 2.42-times higher than in the open surgery group (HR, 2.45; 95% CI, 1.30 to 4.60, P=0.005). Patients that underwent minimally invasive surgery using a uterine manipulator had a 2.76-times higher hazard of relapse (HR, 2.76; 95% CI, 1.75 to 4.33; P<0.001) and those without the use of a uterine manipulator had similar disease-free-survival to the open surgery group (HR, 1.58; 95% CI, 0.79 to 3.15; P=0.20). Moreover, patients that underwent minimally invasive surgery with protective vaginal closure had similar rates of relapse to those who underwent open surgery (HR, 0.63; 95% CI, 0.15 to 2.59; P<0.52).

Conclusions: Minimally invasive surgery in cervical cancer increased the risk of relapse and death compared with open surgery. In this study, avoiding the uterine manipulator and using maneuvers to avoid tumor spread at the time of colpotomy in minimally invasive surgery was associated with similar outcomes to open surgery. Further prospective studies are warranted.
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September 2020

International radical trachelectomy assessment: IRTA study.

Int J Gynecol Cancer 2019 03 13;29(3):635-638. Epub 2019 Feb 13.

North-Western State Medical University. N.N. Petrov Research Institute of Oncology, Saint-Petersburg, Russian Federation.

Background: Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy.

Primary Objective: To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy.

Study Hypothesis: We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach.

Study Design: This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data.

Inclusion Criteria: Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both).

Exclusion Criteria: Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach.

Primary Endpoint: The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy.

Sample Size: An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.
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March 2019

Radical Trachelectomy Performed During Pregnancy: A Review of the Literature.

Int J Gynecol Cancer 2016 May;26(4):758-62

*First Obstetrics and Gynaecology Clinic, University of Medicine and Pharmacy, Târgu-Mureş; †First Department of Oncologic Surgery, Gynecologic Oncology Unit, Regional Institute of Oncology, Iaşi; and ‡Department of General Surgery, "St. Constantin" Hospital, Braşov, Romania, EU.

Objective: Cervical cancer is one of the most frequent malignant diseases diagnosed during pregnancy. Abdominal or vaginal radical trachelectomies are fertility-preserving alternatives to radical hysterectomy for young women with early-stage cervical cancer that can be performed during ongoing pregnancy.

Methods: A literature review of articles on this subject was conducted through a Medline search for articles published in English or French.

Results: At this moment, 21 cervical cancer patients, including ours (4 stage IA2, 16 IB1, and 1 IB2) who underwent radical trachelectomy during pregnancy have been reported. Of these, 10 were performed by vaginal route and 11 were abdominal radical trachelectomies.

Conclusions: Radical trachelectomy could be offered as an option for pregnant patients with early invasive cervical cancer. It may help women avoid the triple losses of a desired pregnancy, fertility, and motherhood.
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May 2016

Abdominal radical trachelectomy: a Romanian series.

Int J Gynecol Cancer 2014 Mar;24(3):615-9

*First Clinic of Obstetrics and Gynecology, University of Medicine and Pharmacy of Târgu Mureş, Târgu Mureş; and †First Department of Oncologic Surgery, Gynecologic Oncology Unit, Regional Institute of Oncology, Iasi, Romania.

Objective: Abdominal radical trachelectomy (ART) is one of the fertility-sparing procedures in women with early-stage cervical cancer. The published results of ART, in comparison with vaginal radical trachelectomy, so far are limited.

Materials And Methods: This retrospective study comprises all cases of female patients referred to ART with early-stage cervical cancer from 2 gynecologic oncology centers in Romania.

Results: A total of 29 women were referred for ART, but subsequently, fertility could not be preserved in 3 of them. Eleven women had stage IA2 disease (42.3%), 14 (53.8%) women had stage IB1 disease, and 1 (3.8%) woman had stage IB2 disease. Histologic subtypes were 15 (57.6%) squamous, 8 (30.7%) adenocarcinoma, and 3 (11.5%) adenosquamous. There were no major intraoperative complications in both hospitals. Early postoperative complications were mainly related to the type C parametrectomy-bladder dysfunction for more than 7 days (8 [30.7%] women) and prolonged constipation (6 [23.0%] women). Other complications consisted in symptomatic lymphocele in 2 (7.6%) patients, which were drained. Median follow-up time was 20 months (range, 4-43 months). Up to the present time, there has been 1 (3.8%) recurrence in our series. Most patients did not experience late postoperative complications. Three (11.5%) women are amenorrheic, and 1 (3.8%) woman developed a cervical stenosis. Of the 23 women who have normal menstruation and maintained their fertility, a total of 7 (30.4%) women have attempted pregnancy, and 3 (42.8%) of them achieved pregnancy spontaneously. These pregnancies ended in 2 first trimester miscarriages and 1 live birth at term by cesarean delivery.

Conclusions: Our results demonstrate that ART preserves fertility and maintains excellent oncological outcomes with low complication rates.
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March 2014