Ovary Injury
Conditions
Brief summary
In women undergoing laparoscopic ovarian cystectomy which is less harmfull on the ovarian reserve (electrocoagulation or suturing).
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.
Interventions
DEVICE2-0 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.
DEVICEDiathermy
bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian reserve | 3 months | By measuring Anti-mullerian hormone |
Countries
Egypt
Contacts
Primary ContactMohamed Abd elfatah el senity, Lecturer
Backup ContactAhmad Yousef riad, M.B.B.C.H
Outcome results
None listed