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

Ovary Injury Clinical Trial

— Eolsb  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03989856
• Other study ID #: 123456789
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: June 2019
• Source: Ain Shams University
• Contact: Mohamed Abd elfatah el senity, Lecturer
• Phone: +201226573332
• Email: M.elsenity[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ovary Injury

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain shams maternity teaching hospital	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian reserve	By measuring Anti-mullerian hormone	3 months