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出境医 / 临床实验 / Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy. (Eolsb)

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

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 Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : March 15, 2019
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : September 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
Outcome Measures
Primary Outcome Measures :
  1. Ovarian reserve [ Time Frame: 3 months ]
    By measuring Anti-mullerian hormone


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Mohamed Abd elfatah el senity, Lecturer +201226573332 M.elsenity@yahoo.com
Contact: Ahmad Yousef riad, M.B.B.C.H +201093151434 ahmedriadaboelnaga90@gmail.com

Locations
Layout table for location information
Egypt
Ain shams maternity teaching hospital Recruiting
Cairo, Abbasia, Egypt, 11591
Contact: Mohamed abd elfatah elsenity, lecturer    00201226573332    m.elsenity@yahoo.com   
Contact: Ahmed Yousef riad, M.B.B.CH    002010    Ahmedriadaboelnaga90@gmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Mohamed Abd elfattah elsenitt, Lecturer Ain Shams University
Tracking Information
First Submitted Date  ICMJE June 15, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE March 15, 2019
Estimated Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		Ovarian reserve [ Time Frame: 3 months ]
By measuring Anti-mullerian hormone
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.
Official Title  ICMJE Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
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
Condition  ICMJE Ovary Injury
Intervention  ICMJE
  • 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.
  • Device: Diathermy
    bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I
Study Arms  ICMJE
  • 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.

    Intervention: 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.
    Intervention: Device: Diathermy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 20, 2019
Estimated Primary Completion Date September 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989856
Other Study ID Numbers  ICMJE 123456789
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohamed abd elfatah elsenity, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Abd elfattah elsenitt, Lecturer Ain Shams University
PRS Account Ain Shams University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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