The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

Study Overview
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Brief Summary
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The purpose of this study is to investigate the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.

Detailed Description
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Laparoscopic cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. In the present study, with the combined use of serum hormonal evaluation and ultrasound examination, we planned to prospectively investigate the ovarian reserve after the excision of benign ovarian cysts. The damage to ovarian reserve will be evaluated through a 12-months follow-up after the application of bipolar, ultrasonic scalpel electrocoagulation or suture during ovarian cystectomy

Official Title
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The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

Conditions
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Ovarian Cysts

Intervention / Treatment
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* Procedure: Ovarian cystectomy
* Procedure: Ovarian cystectomy
* Procedure: Ovarian cystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 18-40 years Uni/bilateral ovarian cyst(s) without clinical and sonographic suspicion of ovarian cancer Regular menstrual cycles defined as cycle length between 25 and 35 days in the 6 months before surgery Agreement to be enrolled in the study Exclusion criteria: Prior ovarian surgery Surgical necessity to perform adnexectomy Known endocrine disease Post operative pathologic diagnosis was not benign ovarian cyst Oral contraceptive use before surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Laparoscopic ovarian cystectomy using bipolar | Procedure: Ovarian cystectomy<br>* Laparoscopic ovarian cystectomy using bipolar<br>* Other names: laparoscopic ovarian cystectomy using bipolar;|
| Experimental: 2<br>Laparoscopic ovarian cystectomy using ultrasonic scalpel | Procedure: Ovarian cystectomy<br>* Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation<br>* Other names: laparoscopic ovarian cystectomy using ultrasonic scalpel;|
| Active Comparator: 3<br>Laparotomic ovarian cystectomy using suture | Procedure: Ovarian cystectomy<br>* Laparotomic ovarian cystectomy using suture<br>* Other names: Laparotomic ovarian cystectomy using suture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum FSH and E2 assays |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy