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

NCT01556204 | Completed Results

• 1 other identifier: 12-173
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Endometriosis

Keywords

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Operative Time

  Operative time is defined as skin incision to skin closure.

  1st 24 hours

Secondary Outcomes (1)

• Pain

  Baseline, 6-weeks, 6-months

Study Arms (2)

Robotic Surgery

EXPERIMENTAL

Robotic surgery using the da Vinci Surgical System

Procedure: Robotic surgery

Laparoscopy

ACTIVE COMPARATOR

Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.

Procedure: Laparoscopic Surgery

Interventions

Robotic surgery PROCEDURE

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).

Robotic Surgery

Laparoscopic Surgery PROCEDURE

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).

Also known as: Laparoscopy

Laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women 18 years of age or greater who are to undergo laparoscopic treatment of presumed endometriosis, as determined clinically by the operating surgeon.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Soto E, Luu TH, Liu X, Magrina JF, Wasson MN, Einarsson JI, Cohen SL, Falcone T. Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a multicenter, randomized, controlled trial. Fertil Steril. 2017 Apr;107(4):996-1002.e3. doi: 10.1016/j.fertnstert.2016.12.033. Epub 2017 Feb 24.

  PMID: 28238489 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Robotic Surgical Procedures; Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Tommaso Falcone, M.D.
• Organization: Cleveland Clinic

falcont@ccf.org

216-444-1752

Study Officials

• Tommaso Falcone, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 14, 2017
• Results First Posted: August 4, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)