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

NACompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Endometriosis
Interventions
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).

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).

Trial Locations (3)

44195

Cleveland Clinic, Cleveland

85259

Mayo Clinic Arizona, Scottsdale

02115

Brigham & Women's Hospital, Boston

All Listed Sponsors
lead

The Cleveland Clinic

OTHER

NCT01556204 - Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial | Biotech Hunter | Biotech Hunter