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Mini Laparotomy With Laparoscopy for Management of Endometrioma

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Combined minilaparotomy- laparoscopy approach
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Kasr Alainy medical schoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

combined minilaparotomy- laparoscopy approach

Arm Description

women undergo the new technique of surgical treatment of endometriomas of the ovary

Outcomes

Primary Outcome Measures

Recurrance
reappearance of endometriomas in the ipsilateral ovary

Secondary Outcome Measures

Ovarian reserve
Measurment of day 2 serum FSH
Ovarian reserve
measurment of AMH
ovarian reserve
Measurement of antral follicular count

Full Information

First Posted
February 25, 2018
Last Updated
March 6, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03457207
Brief Title
Mini Laparotomy With Laparoscopy for Management of Endometrioma
Official Title
Combined Mini Laparotomy With Laparoscopy Appraoch for Management of Endometrioma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2015 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combined minilaparotomy- laparoscopy approach
Arm Type
Experimental
Arm Description
women undergo the new technique of surgical treatment of endometriomas of the ovary
Intervention Type
Procedure
Intervention Name(s)
Combined minilaparotomy- laparoscopy approach
Intervention Description
Laparoscopic aspiration of cyst then guided its extracorporeal cystectomy then reposition and evaluation by laproscopy
Primary Outcome Measure Information:
Title
Recurrance
Description
reappearance of endometriomas in the ipsilateral ovary
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
Ovarian reserve
Description
Measurment of day 2 serum FSH
Time Frame
6 months after surgery
Title
Ovarian reserve
Description
measurment of AMH
Time Frame
6 months after surgery
Title
ovarian reserve
Description
Measurement of antral follicular count
Time Frame
6 months after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+2001005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Moutaz Elsherbiny, MD
Phone
+20201001588300
Email
mizosherbini@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Mini Laparotomy With Laparoscopy for Management of Endometrioma

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