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

NCT03989856 | Unknown DMC

• 1 other identifier: 123456789
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovary Injury

Outcome Measures

Primary Outcomes (1)

• Ovarian reserve

  By measuring Anti-mullerian hormone

  3 months

Study Arms (2)

Suturing group

EXPERIMENTAL

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

Bipolar group

ACTIVE COMPARATOR

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

Interventions

2-0 polyglican absorbable sutures DEVICE

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.

Suturing group

Diathermy DEVICE

bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I

Bipolar group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• PCO according to Rotterdam criteria.
• Pathological diagnosis of excised ovarian tissue as non endometriotic cyst.
• Previous ovarian surgery.
• Suspected ovarian malignancy.
• Patient whose histopathology showed benign cyst apart from endometrioma.
• Irregular menstrual cycles.
• Post menopausal status.
• Bilateral ovarian cyst.
• AMH \< 0.5 ng/ml.
• Premature ovarian failure in family.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams maternity teaching hospital

Cairo, Abbasia, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Mohamed Abd elfattah elsenitt, Lecturer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Abd elfatah el senity, Lecturer

CONTACT

+201226573332; M.elsenity@yahoo.com

Ahmad Yousef riad, M.B.B.C.H

CONTACT

+201093151434; ahmedriadaboelnaga90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Allocation and concealment will be done by sequentially sealed opaque envelopes. 60 envelopes will be numbered serially from 1 to 60, 30 envelopes will contain the letter c and the other 30 will contain the letter S. In each envelope, the corresponding letter which donates the allocated group will be put according to the randomization table and them all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Model Details: The study population comprises females in childbearing period underwent laparoscopic ovarian cystectomy at Ain Shams University Maternity Hospital, Obstetric and Gynecology Department, Faculty of medicine.

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: June 18, 2019
• Study Start: March 15, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

EG (1)