NCT05357924

Evaluating Ovarian Reserve After Conventional Laparoscopy Versus Robotic Surgery for Bilateral Endometrioma

Status unknown NA Last updated 8 June 2022

What this trial tests

NA trial testing robotic-assisted laparoscopy in Ovarian Endometrioma in 104 participants. Status unknown.

Timeline

19 April 2022

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Medical University of Vienna
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	104
Start date	19 April 2022
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Austria

Drugs / interventions tested

• robotic-assisted laparoscopy
• Conventional laparoscopy

Conditions studied

• Ovarian Endometrioma — all drugs for Ovarian Endometrioma →
• Ovarian Endometriosis — all drugs for Ovarian Endometriosis →

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 45, female only, with Ovarian Endometrioma or Ovarian Endometriosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to perform a randomized study investigating AMH recovery comparing robot-assisted laparoscopy and conventional laparoscopy in patients with bilateral ovarian endometrioma. It is hypothesized that in patients with endometriomas, a robot-assisted approach may provide improved instrument navigation resulting in more precise dissection and therefore removal of less healthy ovarian tissue compared to conventional laparoscopy. AMH is the most widely used parameter for predicting functional ovarian reserve. Postoperative AMH levels were associated with the number of follicles in specimens due to the removal of ovarian cortex during surgery . Furthermore, the reduction in AMH level after surgery is higher in bilateral endometrioma.

The investigators hypothesize, on the basis of Lee at al., 2020, that patients with bilateral endometrioma will have significantly higher AMH levels 6 months after robot-assisted laparoscopy than patients who were treated with conventional laparoscopy.

Therefore, the primary outcome is postoperative serum AMH level recovery in patients undergoing conventional laparoscopy versus robot-assisted laparoscopy.

Aims: The aim of this study is to investigate postoperative differences in ovarian reserve differing between robot-assisted laparoscopy compared to conventional laparoscopy in patients with bilaterial ovarian endometrioma by comparing serum AMH (sAMH) level recovery.

Study population: The study population will consist of women aged between 18 and 45 years who are referred to our gynecologic outpatient clinic due to bilateral endometrioma. Women with an indication for surgery can be included in this trial.

Methods: Laparoscopic-assisted resection of endometriosis will be performed using up to four 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System Si (Intuitive Surgical) using up to five ports as needed. Superficial and deep endometriosis resection will be performed in the usual standard fashion. Histological confirmation of endometriosis will be performed. The primary outcome is postoperative serum AMH (sAMH) level recovery. This will be evaluated 6 months after surgery.

Publications & conference data

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

1. Robotic platforms in gynaecological surgery: past, present, and future.
   Pavone M, Baroni A, Taliento C, Goglia M, et al · · 2024 · cited 10× · PMID 38950530 · DOI 10.52054/fvvo.16.2.024