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Mini Laparotomy With Laparoscopy for Management of Endometrioma

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ClinicalTrials.gov Identifier: NCT03457207
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:

Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).

Aspiration of the cyst:

Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall & to confirm complete aspiration).

Delivery of affected ovary outside the abdominal cavity:

Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.

Re-introduction of the ovary to inside the abdominal cavity:

The stitched ovary is pushed gently inside the abdominal cavity and the minilaparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed.


Condition or disease Intervention/treatment Phase
Endometriosis Procedure: Combined minilaparotomy- laparoscopy approach Not Applicable

Detailed Description:

Under general anaesthesia, the patient is placed in themodified dorsal lithotomy position (to ensure lax anterior abdominal wall). The patient is thenprepped and draped in the usual fashion for an abdominaland vaginal procedure. In non- virgin patients, vaginal speculum is inserted into thevagina to expose the cervix, a uterine manipulator is inserted in the cervix followed by placement of a Foley's catheter in thebladder. As regards port placement, a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).

Aspiration of the cyst:

Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall & to confirm complete aspiration).

Delivery of affected ovary outside the abdominal cavity:

A transverse mini-laparotomy is done (2-3 cm) in the midline 2 cm above the symphysis pubis. A long shanks artery forceps is introduced inside the abdominal cavity (to grasp the affected ovary) under laparoscopic guidance. Then, the artery is pulled gently to the outside to deliver the ovary at the minilaparotomy skin incision. Careful handling and traction is applied to avoid injury of both the ovarian tissue or/andinfundibulopelvic ligament. Following the delivery of the ovary, the abdominal incision is temporary closed using (Eshaped 10 x 10 cm) rubbershield (to avoid any soiling of abdominal cavity with blood or cystic fluid & give the chance to reinflate the abdominal cavity later on).

Ovarian cystectomy:

Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.The stitched ovary is pushed gently inside the abdominal cavity and the minilaparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Mini Laparotomy With Laparoscopy Appraoch for Management of Endometrioma
Actual Study Start Date : January 2, 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: combined minilaparotomy- laparoscopy approach
women undergo the new technique of surgical treatment of endometriomas of the ovary
Procedure: Combined minilaparotomy- laparoscopy approach
Laparoscopic aspiration of cyst then guided its extracorporeal cystectomy then reposition and evaluation by laproscopy




Primary Outcome Measures :
  1. Recurrance [ Time Frame: 2 years after surgery ]
    reappearance of endometriomas in the ipsilateral ovary


Secondary Outcome Measures :
  1. Ovarian reserve [ Time Frame: 6 months after surgery ]
    Measurment of day 2 serum FSH

  2. Ovarian reserve [ Time Frame: 6 months after surgery ]
    measurment of AMH

  3. ovarian reserve [ Time Frame: 6 months after surgery ]
    Measurement of antral follicular count



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral or bilateral ovarian endometriotic cysts (≥ 10 cm),
  • recurrent ovarian cysts
  • good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml & antral follicular count {AFC} > 4)

Exclusion Criteria:

  • solid ovarian masses
  • patients who were unfit for surgery
  • chronic diseases (e.g. cardiac disease or diabetes)
  • any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457207


Contacts
Contact: Ahmed Maged, MD +2001005227404 prof.ahmedmaged@gmail.com
Contact: Moutaz Elsherbiny, MD +20201001588300 mizosherbini@yahoo.com

Locations
Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12111
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Ahmed Maged, MD professor

Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03457207     History of Changes
Other Study ID Numbers: 30
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female