Trial Outcomes & Findings for Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy (NCT NCT00683293)

NCT ID: NCT00683293

Last Updated: 2014-04-16

Results Overview

•Mean Time to complete surgery from cut to suture

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: after surgey
• Results posted on: 2014-04-16

Participant Flow

2008 to 2011 All patients were recruited from our clinic

Participant milestones

Measure	1 Conventional Laparoscopic Hysterectomy Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques	2 Robot-assisted Laparoscopic Hysterectomy group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
Overall Study STARTED	50	50
Overall Study COMPLETED	48	47
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	1 Conventional Laparoscopic Hysterectomy Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques	2 Robot-assisted Laparoscopic Hysterectomy group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy

Baseline characteristics by cohort

Measure	1 Conventional Laparoscopic Hysterectomy n=50 Participants Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques	2 Robot-assisted Laparoscopic Hysterectomy n=50 Participants group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.8 years STANDARD_DEVIATION 6 • n=5 Participants	46.3 years STANDARD_DEVIATION 4.2 • n=7 Participants	46 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Switzerland	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: after surgey

•Mean Time to complete surgery from cut to suture

Outcome measures

Measure	1 Conventional Laparoscopic Hysterectomy n=48 Participants Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques	2 Robot-assisted Laparoscopic Hysterectomy n=47 Participants group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
Duration of Surgery	75 minutes Standard Deviation 21	106 minutes Standard Deviation 29

SECONDARY outcome

Timeframe: up to 2 weeks

Outcome measures

Measure	1 Conventional Laparoscopic Hysterectomy n=48 Participants Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques	2 Robot-assisted Laparoscopic Hysterectomy n=47 Participants group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
Complications	4 participants	5 participants

Adverse Events

1 Conventional Laparoscopic Hysterectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Robot-assisted Laparoscopic Hysterectomy

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

Dimtri SARLOS

Kantonsspital Aarau

Phone: 00418384141

Email: la.kots@ksa.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place