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

Not Applicable

Completed

• Conditions: Laparoscopic Technique no Switch to Open; Duration of Surgery; Intraoperative Complications; Postoperative Complications
• Interventions: Procedure: Conventional Laparoscopic Hysterectomy; Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy

• Registration Number: NCT00683293
• Lead Sponsor: Kantonsspital Aarau

Brief Summary

The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

Detailed Description

During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.

Study Timeline

• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-23
• Study Start: 2008-11
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Results First Submitted: 2013-11-12
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-11
• Last Update Submitted: 2014-03-11
• Results First Posted: 2014-04-16
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Indication for laparoscopic hysterectomy
• Patients BMI < 40
• Signed consent

Exclusion Criteria

• Estimated uterus weight >400 g
• No combination with other procedures
• No underlying malignant condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Conventional Laparoscopic Hysterectomy	Randomized group of patients receiving conventional laparoscopic hysterectomy
2	Robot-assisted (Da Vinci®) laparoscopic hysterectomy	Randomized group of patients receiving robot-assisted laparoscopic hysterectomy

Primary Outcome Measures

Name	Time	Method
Duration of Surgery	after surgey	•Mean Time to complete surgery from cut to suture

Secondary Outcome Measures

Name	Time	Method
Complications	up to 2 weeks

Trial Locations

Locations (1)

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland