Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.
NCT ID: NCT03989856
Last Updated: 2019-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-03-15
2019-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
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.
Study Groups
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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.
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.
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.
Diathermy
bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed abd elfatah elsenity
Lecturer of obstetrics and gynecology
Principal Investigators
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Mohamed Abd elfattah elsenitt, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Ain shams maternity teaching hospital
Cairo, Abbasia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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123456789
Identifier Type: -
Identifier Source: org_study_id
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