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

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03989856

Collaborator

(none)

Enrollment

Location

Arms

6.2

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ovary Injury	Device: 2-0 polyglican absorbable sutures Device: Diathermy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 15, 2019

Anticipated Primary Completion Date :

Sep 20, 2019

Anticipated Study Completion Date :

Sep 20, 2019

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

Ovarian reserve [3 months]
By measuring Anti-mullerian hormone

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain shams maternity teaching hospital	Cairo	Abbasia	Egypt	11591

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Mohamed Abd elfattah elsenitt, Lecturer, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed abd elfatah elsenity, Lecturer of obstetrics and gynecology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03989856

Other Study ID Numbers:

123456789

First Posted:

Jun 18, 2019

Last Update Posted:

Jun 18, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 18, 2019