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

NCT05357924 | Unknown

• 1 other identifier: AMH robotic LSK
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Endometrioma; Ovarian Endometriosis

Outcome Measures

Primary Outcomes (1)

• Change in serum AMH (sAMH) from baseline to 6 months after the operation

  postoperative sAMH (6 months after the operation) compared to preoperative sAMH

  6 months after the operation

Secondary Outcomes (13)

• Change in antral follicle count (AFC) from baseline to 6 months after the operation

  6 months after the operation

• change in ovarian volume from baseline to 6 months after the operation

  6 months after the operation

• change in follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from baseline to 6 months after the operation

  6 months after the operation

• rate of intraoperative adverse events

  1 day

• rate of postoperative adverse events

  4 weeks

Study Arms (2)

robotic-assisted laparoscopy

ACTIVE COMPARATOR

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. An umbilical port was placed for the laparoscope (10/12 mm), a 5-mm port for the assistant, and two to three ports (5/8 mm) for the robotic arms.

Procedure: robotic-assisted laparoscopy

conventional laparoscopy

ACTIVE COMPARATOR

Laparoscopic-assisted cystectomy of endometrioma will be performed using up to four 5-mm ports, including an umbilical port and additional ports as dictated by each individual surgery.

Procedure: Conventional laparoscopy

Interventions

robotic-assisted laparoscopy PROCEDURE

Superficial and deep endometriosis resection will be performed in the usual standard fashion. All superficial lesions suspicious for endometriosis (pigmented and nonpigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy will be performed for endometriomas. Additional procedures are performed as needed to completely resect all endometriosis lesions. The fascia of any port ≥10 mm will be reapproximated. Cystoscopy will be performed when deemed appropriate by the surgeon. If bowel resection and re-anastomosis is necessary this will be performed together with a General Surgeon.

Also known as: DaVinci laparoscopy

robotic-assisted laparoscopy

Conventional laparoscopy PROCEDURE

Superficial and deep endometriosis resection will be performed in the usual standard fashion. All superficial lesions suspicious for endometriosis (pigmented and nonpigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy will be performed for endometriomas. Additional procedures are performed as needed to completely resect all endometriosis lesions. The fascia of any port ≥10 mm will be reapproximated. Cystoscopy will be performed when deemed appropriate by the surgeon. If bowel resection and re-anastomosis is necessary this will be performed together with a General Surgeon.

conventional laparoscopy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Bilateral endometrioma
• Surgical endometriosis resection is planned
• sAMH \> 1.0 ng/ml

You may not qualify if:

• History of malignant diseases
• History of adnexal surgery
• Subject is unable or unwilling to participate
• Postmenopausal women

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

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

• Rene Wenzl

  Medical University of Vienna, Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Central Study Contacts

Christine Bekos

CONTACT

004369913536030; christine.bekos@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principan Investigator

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: April 19, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)