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

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

Study Overview

• Status: Unknown
• Conditions: Ovary Injury
• Intervention / Treatment: Device: 2-0 polyglican absorbable sutures; Device: Diathermy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11591
      • Recruiting
      • Ain shams maternity teaching hospital
      • Contact: Mohamed abd elfatah elsenity, lecturer; Phone Number: 00201226573332; Email: m.elsenity@yahoo.com
      • Contact: Ahmed Yousef riad, M.B.B.CH; Phone Number: 002010; Email: Ahmedriadaboelnaga90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Suturing group; 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.	Device: 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.
ACTIVE_COMPARATOR: Bipolar group; 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.	Device: Diathermy; bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovarian reserve	By measuring Anti-mullerian hormone	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mohamed Abd elfattah elsenitt, Lecturer, AIN shams university

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2019
• Primary Completion (ANTICIPATED): September 20, 2019
• Study Completion (ANTICIPATED): September 20, 2019

Study Registration Dates

• First Submitted: June 15, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (ACTUAL): June 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 123456789 (Bandirma Onyedi Eylul University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No