N/A
N=73
Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT01556204 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Operative Time — 106.6; 101.6 minutes — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Robotic surgery (Procedure); Laparoscopic Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Operative Time |
106.6; 101.6 | 0.71 |
| SECONDARY Pain |
51.2; 54.2; 28.6; 25.3; 24.8; 21.5 | 0.53 |
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.
Eligibility Criteria
Inclusion Criteria
- women 18 years of age or greater who are to undergo laparoscopic treatment of presumed endometriosis, as determined clinically by the operating surgeon.
Exclusion Criteria
- suspected malignancy,
- medical illness precluding laparoscopy,
- inability to give informed consent,
- morbid obesity (BMI > 44), or
- need for concomitant bowel resection and/or ureteral reanastomosis.
Data sourced from ClinicalTrials.gov (NCT01556204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.