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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556204
First Posted: March 16, 2012
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose
The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.

Condition Intervention
Endometriosis Procedure: Robotic surgery Procedure: Laparoscopic Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Operative Time [ Time Frame: 1st 24 hours ]
    Operative time is defined as skin incision to skin closure.


Secondary Outcome Measures:
  • 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.


Enrollment: 73
Study Start Date: March 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robotic Surgery
Robotic surgery using the da Vinci Surgical System
Procedure: Robotic surgery
The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).
Active Comparator: Laparoscopy
Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.
Procedure: Laparoscopic Surgery
The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).
Other Name: Laparoscopy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556204


Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Tommaso Falcone, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01556204     History of Changes
Other Study ID Numbers: 12-173
First Submitted: March 13, 2012
First Posted: March 16, 2012
Results First Submitted: May 16, 2016
Results First Posted: August 4, 2016
Last Update Posted: February 14, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female