Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.

Not Applicable

• Conditions: Ovary Injury
• Interventions: Device: 2-0 polyglican absorbable sutures; Device: Diathermy

• Registration Number: NCT03989856
• Lead Sponsor: Ain Shams University

Brief Summary

In women undergoing laparoscopic ovarian cystectomy which is less harmfull on the ovarian reserve (electrocoagulation or suturing).

Detailed Description

The aim of the present study was to determine which hemostatic procedure (hemostatic suture or electrocautery) may be less harmful after laparoscopic cystectomy, based on the longterm status of the ovarian reserve.

Study Timeline

• Study Start: 2019-03-15
• Status Verified: 2019-06
• Study First Submitted: 2019-06-15
• Study First Submitted QC: 2019-06-17
• Last Update Submitted: 2019-06-17
• Study First Posted: 2019-06-18
• Last Update Posted: 2019-06-18
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Age 18- 45.
2. Regular menstrual cycle.
3. Unilateral ovarian cyst clinical & us finding as endometriotic cyst.
4. C/O of pelvic pain.
5. No medications (oral pills & hormonal drugs) in the past 3 monthes before enrollement.
6. No evidence of endocrine disorders (DM, Thyroid dysfunction,hyper prolactenemia, congenital adrenal hyperplesia, cushing's syndrome or adrenal insufficiency)
7. No previous adnexial surgery.
8. Pathology diagnosis of excised ovarian tissue (endometriotic cyst)
9. Appropriate medical condition for laparoscopic surgery.
10. Completely understand the process of the study with written consent.

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Exclusion Criteria

1. PCO according to Rotterdam criteria.
2. Pathological diagnosis of excised ovarian tissue as non endometriotic cyst.
3. Previous ovarian surgery.
4. Suspected ovarian malignancy.
5. Patient whose histopathology showed benign cyst apart from endometrioma.
6. Irregular menstrual cycles.
7. Post menopausal status.
8. Bilateral ovarian cyst.
9. AMH < 0.5 ng/ml.
10. Premature ovarian failure in family.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suturing group	2-0 polyglican absorbable sutures	The sutures will be performed with intracorporeal knots using 2-0 polyglican absorbable sutures (Vicryl; Ethicon Inc., New Jersey, USA). Suture is performed using needle holders for the closure of ovarian parenchyma and controlling bleeding. Bleeding from ovarian hilus will only resolve by suturing. The running suture starting from central area, around the ovarian hilus to peripheral tissue, will be performed with intraovarian knots to re-approximate the edges to achieve satisfying hemostasis. Knots will not be detectable on the ovarian surface for prevention of adhesion. Mean time for hemostasis of ovary was recorded in a form. The cyst wall will be removed from the abdomen by means of an endobag. All resected cyst walls will be sent to the pathology laboratory, to confirm the histopathology of endometriosis.
Bipolar group	Diathermy	In bipolar coagulation group, after stripping the ovarian cyst wall, bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). In laparoscopic suturing group, no bipolar coagulation will be performed during or after stripping the ovarian cyst wall.

Primary Outcome Measures

Name	Time	Method
Ovarian reserve	3 months	By measuring Anti-mullerian hormone

Trial Locations

Locations (1)

Ain shams maternity teaching hospital; 🇪🇬 Cairo, Abbasia, Egypt