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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683293
First Posted: May 23, 2008
Last Update Posted: April 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dimitri Sarlos, Kantonsspital Aarau
  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 Technique no Switch to Open Duration of Surgery Intraoperative Complications Postoperative Complications Procedure: Conventional Laparoscopic Hysterectomy Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques

Resource links provided by NLM:


Further study details as provided by Dimitri Sarlos, Kantonsspital Aarau:

Primary Outcome Measures:
  • Duration of Surgery [ Time Frame: after surgey ]
    •Mean Time to complete surgery from cut to suture


Secondary Outcome Measures:
  • Complications [ Time Frame: up to 2 weeks ]

Enrollment: 100
Study Start Date: November 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Randomized group of patients receiving conventional laparoscopic hysterectomy
Procedure: Conventional Laparoscopic Hysterectomy
Removal of uterus via standard laparoscopic techniques
Other Names:
  • - Minimal invasive hysterectomy,
  • - Laparoscopic removal of uterus,
  • - Minimal invasive removal of uterus
Active Comparator: 2
Randomized group of patients receiving robot-assisted laparoscopic hysterectomy
Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy
Removal of uterus by robot-assisted laparoscopic technique
Other Names:
  • - Robot-assisted(Da Vinci®)laparoscopic hysterectomy
  • - Robot-assisted minimal invasive hysterectomy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683293


Locations
Switzerland
Kantonsspital Aarau
Aarau, Switzerland
Sponsors and Collaborators
Kantonsspital Aarau
Investigators
Study Chair: Dimitri Sarlos, MD Kantonsspital Aarau
  More Information

Publications:
Responsible Party: Dimitri Sarlos, Head Gynaecology and oncological Gynaecology, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT00683293     History of Changes
Other Study ID Numbers: KSA-RobHyst
First Submitted: May 21, 2008
First Posted: May 23, 2008
Results First Submitted: November 12, 2013
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014

Keywords provided by Dimitri Sarlos, Kantonsspital Aarau:
Laparoscopic Hysterectomy
Robot-assisted Laparoscopic Hysterectomy
Robot-assisted Surgery

Additional relevant MeSH terms:
Postoperative Complications
Intraoperative Complications
Pathologic Processes