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

This study is currently recruiting participants.
Verified January 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01556204
First received: March 13, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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: Surgery for endometriosis

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

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Operative Time [ Time Frame: 1st 24 hours ] [ Designated as safety issue: No ]
    Operative time is defined as skin incision to skin closure.


Secondary Outcome Measures:
  • Pain [ Time Frame: Baseline, 2-weeks, 6-weeks, 6-months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Activity assessment questionnaire will be applied.

  • Pain [ Time Frame: Baseline, 2-weeks, 6-weeks, 6-months ] [ Designated as safety issue: No ]
    A visual analog scale will be utilized as well as specific questionnaires SF-12, EHP-30 and daily pain medication diaries.


Estimated Enrollment: 74
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robotic Surgery
da Vinci Surgical System
 Procedure: Surgery for endometriosis
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 Names:
  • Endometriosis
  • Laparoscopy
  • Robotics
  • Robotic Surgery
Active Comparator: Laparoscopy
Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.
 Procedure: Surgery for endometriosis
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 Names:
  • Endometriosis
  • Laparoscopy
  • Robotics
  • Robotic Surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556204

Contacts
Contact: Enrique Soto, MD, MS 216-445-8090 sotoe@ccf.org
Contact: Ly Pung 216-445-8090 pungl@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Enrique Soto, MD, MS     216-445-8090     sotoe@ccf.org    
Contact: Ly Pung     216-445-8090     pungl@ccf.org    
Principal Investigator: Enrique Soto, MD, MS            
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Enrique Soto, MD, MS The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01556204     History of Changes
Other Study ID Numbers: 12-173
Study First Received: March 13, 2012
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 17, 2013