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A randomized controlled trial of a new technique for laparoscopic management of ovarian endometriosis preventing recurrence and keeping ovarian reserve.

ABSTRACT: INTRODUCTION:Laparoscopic cystectomy provides more favourable outcomes as regards the recurrence and subsequent clinical pregnancy rates. It is associated with significant reduction in the ovarian reserve due to the inevitable removal of unaffected ovarian tissue. The aim of our study was to evaluate the efficiency of Surgicel in preventing recurrence of endometriomas after their laparoscopic conservative management (cystectomy or drainage). MATERIAL AND METHODS:A randomized controlled trial included two hundred women (candidate for conservative laparoscopic management of ovarian endometriomas). They were randomized into four groups; group D in which patients underwent laparoscopic drainage of the endometrioma, group C in which patients underwent laparoscopic cystectomy of the endometrioma, group DS in which patients underwent laparoscopic drainage followed by insertion of Surgicel inside the cyst cavity & group CS in which patients underwent laparoscopic cystectomy of the endometrioma followed by insertion of Surgicel inside the remaining ovarian tissues. All patients were followed up for 2?years & the primary outcome was the recurrence of endometriomas in the ipsilateral ovary & the postoperative ovarian reserve was reassessed as a secondary outcome. RESULTS:The Surgicel-treated groups had significantly lower hazard of recurrence compared to untreated groups (p?=?0.004). Group CS had significantly lower hazard of recurrence compared to Group D & C (p?=?0.014, 0.046 respectively). Group DS had significantly lower hazard of recurrence compared to Group D (p?=?0.039) but it not significantly different from Group C (p?=?0.112). Group DS had the lowest drop of AMH and was significantly lower than the other three groups. CONCLUSION:Surgicel reduces effectively the recurrence risk of endometriomas and its use during laparoscopic drainage is an effective alternative for traditional laparoscopic cystectomy with minimal affection of the patient ovarian reserve. TRIAL REGISTRATION:Name of the registry: clinicaltrials.gov. Trial registration number NCT02947724 . Date of registration October 28, 2016.

SUBMITTER: Shaltout MF

PROVIDER: S-EPMC6642736 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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A randomized controlled trial of a new technique for laparoscopic management of ovarian endometriosis preventing recurrence and keeping ovarian reserve.

Shaltout Mohamed F MF Elsheikhah Ahmad A Maged Ahmed M AM Elsherbini Moutaz M MM Zaki Sherif S SS Dahab Sherif S Elkomy Rasha O RO

Journal of ovarian research 20190720 1

<h4>Introduction</h4>Laparoscopic cystectomy provides more favourable outcomes as regards the recurrence and subsequent clinical pregnancy rates. It is associated with significant reduction in the ovarian reserve due to the inevitable removal of unaffected ovarian tissue. The aim of our study was to evaluate the efficiency of Surgicel in preventing recurrence of endometriomas after their laparoscopic conservative management (cystectomy or drainage).<h4>Material and methods</h4>A randomized contr ...[more]

PMID: 31325962

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Project description:BackgroundEndometriosis (EMS) can be implanted everywhere, especially in pelvic organs. EMS can be asymptomatic, but it can result in pelvic pain and infertility by inducing local inflammation and pelvic adhesion. The prevalence of EMS is about 10% in reproductive-age women and higher in women with pelvic pain or infertility. For young patients with ovarian EMS, laparoscopic ovarian cystectomy is effective in relieving pelvic pain and preventing local recurrence. However, there is a concern that the ovarian reserve would decrease after the operation because of the removal of a part of the normal ovarian tissue and thermal damage during hemostasis, which depends on the types of hemostasis such as bipolar electrocoagulation, suturing, and the use of a hemostatic agent. In this study, we aim to evaluate the protective effect for the ovarian reserve and hemostasis between a hemostatic agent and suturing during laparoscopic ovarian cystectomy for patients with ovarian EMS.MethodsThis study is a randomized controlled, non-inferiority trial, where a total of 90 patients with ovarian EMS will be randomly assigned to the experimental (hemostatic agent) and control (suturing) groups. In the control group, a barbed suture will be applied for hemostasis, whereas a hemostatic agent will be applied in the experimental group. If two methods are insufficient, bipolar electrocoagulation will be applied for complete hemostasis. As the primary endpoint, the reduction rate of serum anti- Müllerian hormone (AMH) levels reflecting the ovarian reserve will be compared between the two groups 12 weeks after surgery. As secondary endpoints, we will compare the reduction rate of AMH level 48 weeks after surgery, the time required to complete hemostasis, the success rate of hemostasis within 10 min, and adverse events associated with operation.DiscussionWe expect that the protective effect for the ovarian reserve and hemostasis may be comparable between the two methods, suggesting that a hemostatic agent may be preferred considering that it is easy to use during laparoscopic ovarian cystectomy.Trial registrationClinicalTrials.gov NCT04643106 . Registered on 22 November 2020.

Project description:BackgroundThis study investigated the feasibility and safety of laparoscopic splenectomy conducted in the contexts of both laparoscopic secondary surgery for isolated recurrence in the spleen and primary laparoscopic cytoreductive surgery for advanced ovarian cancer.MethodsWe performed a perspective observational study including all consecutive patients with ovarian cancer who underwent laparoscopic splenectomy as part of primary cytoreductive procedures for advanced stage ovarian cancer or secondary surgery for isolated splenic recurrence between January 2016 and May 2020.ResultsWe enrolled 13 consecutive patients, candidate to laparoscopic splenectomy as part of primary cytoreductive procedures for advanced stage ovarian cancer (6 patients) or secondary surgery for isolated splenic recurrence of platinum-sensitive ovarian cancer (7 patients). Median operative time (509 min [range, 200-845]) for primary cytoreductive surgery varied according to surgical complexity depending on the extensiveness of the disease. Median operative time for secondary surgery for isolated splenic metastasis was 253 min (90-380). Only 1 patient with isolated splenic recurrence required conversion to an open approach. No intraoperative complication occurred, and no intraoperative blood transfusions were required. Median hospital stay was 3 days (range, 2-5) for isolated recurrence and 9 days (7-18) for primary cytoreductive surgery. Complete tumor resection was achieved in all patients. Median time from surgery to adjuvant chemotherapy was 16 days (7-24). All six patients who underwent laparoscopic splenectomy during primary cytoreductive surgery remain alive, four of whom exhibit no evidence of disease (median follow-up 25 months [4-36]). Among patients who underwent laparoscopic splenectomy during secondary surgery for isolated splenic relapse, all patients are alive and only one had a central diaphragmatic relapse 2 years after surgery (median follow-up 17 months ([5-48 months]).ConclusionsThe laparoscopic approach to splenectomy is feasible and safe both in patients undergoing primary cytoreductive surgery for advanced stage disease and those with isolated recurrence of ovarian cancer, without compromising survival and allowing early initiation of postoperative systemic chemotherapy.

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A randomized controlled trial of a new technique for laparoscopic management of ovarian endometriosis preventing recurrence and keeping ovarian reserve.

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A randomized controlled trial of a new technique for laparoscopic management of ovarian endometriosis preventing recurrence and keeping ovarian reserve.

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