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

Ain Shams University

Status: Unknown

Conditions: Ovary Injury

Treatments: Device: Diathermy; Device: 2-0 polyglican absorbable sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT03989856

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Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Suturing group

Experimental group

Description:

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.

Treatment:

Device: 2-0 polyglican absorbable sutures

Bipolar group

Active Comparator group

Description:

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.

Treatment:

Device: Diathermy