Clinical Trial: Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial

Brief Summary: The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.

Detailed Summary:

This is a prospective randomized control trial. Study subjects will be recruited from patients that present to the Department of Gynecology who are to have surgery for endometriosis at the Cleveland Clinic.

Patient that require bowel resection and/or ureteral reanastomosis are not included due to the fact that these events impact operating time significantly and are not commonly performed as part of endometriosis surgery (subjects may not be equally distributed among both arms).

Eligible patients that agree to participate will be provided written informed consent administered by the collaborators listed on this Institutional Review Board (IRB) at the above clinic locations. In addition to a standardized evaluation including the history and physical examination, the patients will complete the validated health-related quality of life questionnaires SF-12 and Endometriosis Health Profile-30 (EHP-30) with additional questions to determine baseline pain and activity scales as well as daily pain medication use.

Surgeries will be performed by two board certified gynecologic surgeons (TF and JG). JG will participate in the laparoscopic arm of the study (Beachwood Family Health and Surgery Center) while TF will participate in both arms (Cleveland Clinic main campus). The patients of JG randomized to robotic surgery will be performed by TF at Cleveland Clinic main campus.

Additionally, after the surgery, the patients will complete the above questionnaires as well as diaries addressing narcotic use and quality of life at 6 weeks and 6 months. Completion of questionnaires and diaries is the only additional assessment that is specific to participation in this study that is not usually included as part of the standard care for the treatme
Sponsor: The Cleveland Clinic

Current Primary Outcome: Operative Time [ Time Frame: 1st 24 hours ]

Operative time is defined as skin incision to skin closure.


Original Primary Outcome: Same as current

Current Secondary Outcome: Pain [ Time Frame: Baseline, 6-weeks, 6-months ]

Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.


Original Secondary Outcome:

  • Pain [ Time Frame: Baseline, 2-weeks, 6-weeks, 6-months ]
    A visual analog scale will be utilized as well as specific questionnaires (SF-12 and EHP-30.
  • Activity Assessment [ Time Frame: Baseline, 2-weeks, 6-weeks, 6-months ]
    Activity assessment questionnaire will be applied.
  • Pain [ Time Frame: Baseline, 2-weeks, 6-weeks, 6-months ]
    A visual analog scale will be utilized as well as specific questionnaires SF-12, EHP-30 and daily pain medication diaries.


Information By: The Cleveland Clinic

Dates:
Date Received: March 13, 2012
Date Started: March 2012
Date Completion:
Last Updated: December 22, 2016
Last Verified: December 2016