Mini Laparotomy With Laparoscopy for Management of Endometrioma

Not Applicable

• Conditions: Endometriosis
• Interventions: Procedure: Combined minilaparotomy- laparoscopy approach

• Registration Number: NCT03457207
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01-02
• Study First Submitted: 2018-02-25
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-06
• Last Update Submitted: 2018-03-06
• Study First Posted: 2018-03-07
• Last Update Posted: 2018-03-07
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
combined minilaparotomy- laparoscopy approach	Combined minilaparotomy- laparoscopy approach	women undergo the new technique of surgical treatment of endometriomas of the ovary

Primary Outcome Measures

Name	Time	Method
Recurrance	2 years after surgery	reappearance of endometriomas in the ipsilateral ovary

Secondary Outcome Measures

Name	Time	Method
Ovarian reserve	6 months after surgery	measurment of AMH
ovarian reserve	6 months after surgery	Measurement of antral follicular count

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt