Clinical Trial Comparing Conventional and Robot-Assited(Da Vinci®)Laparoscopic Interventions for Hysterectomy - Full Text View

Sponsored by:	Kantonsspital Aarau
Information provided by:	Kantonsspital Aarau
ClinicalTrials.gov Identifier:	NCT00683293

Purpose

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

Condition	Intervention
Laparoscopic Hysterectomy Duration of Surgery Intra-Opertaive Complications Postoperative Complications	Procedure: Conventional Laparoscopic Hysterectomy Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy

MedlinePlus related topics: Hysterectomy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-Assited(Da Vinci®)Techniques

Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:

duration of surgery [ Time Frame: after surgey ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

complications [ Time Frame: within hospitalisation ] [ Designated as safety issue: Yes ]
costs [ Time Frame: during hospitalisation ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Randomized group of patients receiving conventional laparoscopic hysterectomy	Procedure: Conventional Laparoscopic Hysterectomy Removal of uterus via standard laparoscopic techniques
2: Active Comparator Randomized group of patients receiving robot-assisted laparoscopic hysterectomy	Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy Removal of uterus by robot-assisted laparoscopic technique

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683293

Contacts

Contact: Dimitri Sarlos, MD

+41(0)62 838 5065

Dimitri.Sarlos@ksa.ch

Locations

Switzerland
Kantonsspital Aarau	Recruiting
Aarau, Switzerland

Sponsors and Collaborators

Kantonsspital Aarau

Investigators

Study Chair:

Dimitri Sarlos, MD

Kantonsspital Aarau

More Information

Responsible Party:	Kantonspital Aarau/ Department of Gynecology & Obstetrics ( Dimitri Sarlos/ Vice Chairmain )
Study ID Numbers:	KSA-RobHyst
Study First Received:	May 21, 2008
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00683293
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Kantonsspital Aarau:

Laparoscopic Hysterectomy
Robot-assisted Laparoscopic Hysterectomy
Robot-assisted Sugery

Study placed in the following topic categories:

Postoperative Complications

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009