Mini Laparotomy With Laparoscopy for Management of Endometrioma

NCT03457207 | Unknown DMC

• 1 other identifier: 30
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Recurrance

  reappearance of endometriomas in the ipsilateral ovary

  2 years after surgery

Secondary Outcomes (3)

• Ovarian reserve

  6 months after surgery

• Ovarian reserve

  6 months after surgery

• ovarian reserve

  6 months after surgery

Study Arms (1)

combined minilaparotomy- laparoscopy approach

EXPERIMENTAL

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

Procedure: Combined minilaparotomy- laparoscopy approach

Interventions

Combined minilaparotomy- laparoscopy approach PROCEDURE

Laparoscopic aspiration of cyst then guided its extracorporeal cystectomy then reposition and evaluation by laproscopy

combined minilaparotomy- laparoscopy approach

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ahmed Maged, MD

  professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404; prof.ahmedmaged@gmail.com

Moutaz Elsherbiny, MD

CONTACT

+20201001588300; mizosherbini@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 7, 2018
• Study Start: January 2, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

EG (1)