NCT03370952

Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH

Completed NA Last updated 11 January 2022

What this trial tests

NA trial testing laproscopy in Ovarian Cysts in 112 participants. Completed in 3 August 2019.

Timeline

21 December 2017

Primary endpoint
5 July 2019

3 August 2019

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	21 December 2017
Primary completion	5 July 2019
Estimated completion	3 August 2019
Sites	1 location across Egypt

Drugs / interventions tested

• laproscopy
• combined laproscopic and minilaparotomy ovarian cystectomy

Conditions studied

• Ovarian Cysts — all drugs for Ovarian Cysts →

Sponsor

Cairo University

Who can join

Adults 20 to 35, female only, with Ovarian Cysts. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 mini-laparotomy 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Laparoscopic guided minilaparotomy: a modified technique for management of benign large ovarian cysts.
   Shaltout MF, Maged AM, Abdella R, Sediek MM, et al · · 2022 · cited 2× · PMID 35787807 · DOI 10.1186/s12905-022-01853-4