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NCT00683293 Clinical Trial

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

Postoperative Complications Clinical Trial

Official title:
Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00683293
Other study ID # KSA-RobHyst
Secondary ID
Status Completed
Phase N/A
First received May 21, 2008
Last updated March 11, 2014
Start date November 2008
Est. completion date December 2011

Study information
Verified date March 2014
Source Kantonsspital Aarau
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Conventional Laparoscopic Hysterectomy
Removal of uterus via standard laparoscopic techniques
• Robot-assisted (Da Vinci®) laparoscopic hysterectomy
Removal of uterus by robot-assisted laparoscopic technique

Locations
Country Name City State
Switzerland Kantonsspital Aarau Aarau

Sponsors (1)
Lead Sponsor Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Sarlos D, Kots L, Stevanovic N, von Felten S, Schär G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of Surgery •Mean Time to complete surgery from cut to suture after surgey No
Secondary Complications up to 2 weeks No
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