Trial Outcomes & Findings for Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial (NCT NCT01556204)

Results Overview

Operative time is defined as skin incision to skin closure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

1st 24 hours

Results posted on

2017-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Robotic Surgery da Vinci Surgical System 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; 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).	Laparoscopy Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports. 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; 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).
Overall Study STARTED	35	38
Overall Study COMPLETED	35	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic n=35 Participants Robotic surgery	Laparoscopic n=38 Participants Laparoscopic surgery	Total n=73 Participants Total of all reporting groups
Age, Continuous	34.3 years STANDARD_DEVIATION 7.2 • n=5 Participants	34.5 years STANDARD_DEVIATION 8.5 • n=7 Participants	34.5 years STANDARD_DEVIATION 8.5 • n=5 Participants
Gender Female	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	38 participants n=7 Participants	73 participants n=5 Participants

PRIMARY outcome

Timeframe: 1st 24 hours

Operative time is defined as skin incision to skin closure.

Outcome measures

Outcome measures
Measure	Robotic Surgery n=35 Participants da Vinci Surgical System 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; 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).	Laparoscopy n=38 Participants Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports. 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; 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).
Operative Time	106.6 minutes Standard Deviation 48.8	101.6 minutes Standard Deviation 63.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Robotic Surgery n=35 Participants da Vinci Surgical System 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; 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).	Laparoscopy n=38 Participants Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports. 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; 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).
Pain Baseline	51.2 units on a scale Standard Deviation 18.1	54.2 units on a scale Standard Deviation 16
Pain 6-weeks	28.6 units on a scale Standard Deviation 23.7	25.3 units on a scale Standard Deviation 21.6
Pain 6-months	24.8 units on a scale Standard Deviation 26.5	21.5 units on a scale Standard Deviation 23.9

Adverse Events

Robotic Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laparoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tommaso Falcone, M.D.

Cleveland Clinic

Phone: 216-444-1752

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place