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

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. Identifier: NCT00683293
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):
Dimitri Sarlos, 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Technique no Switch to Open Duration of Surgery Intraoperative Complications Postoperative Complications Procedure: Conventional Laparoscopic Hysterectomy Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00683293

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Kantonsspital Aarau
Aarau, Switzerland
Sponsors and Collaborators
Kantonsspital Aarau
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Study Chair: Dimitri Sarlos, MD Kantonsspital Aarau
Publications of Results:
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Responsible Party: Dimitri Sarlos, Head Gynaecology and oncological Gynaecology, Kantonsspital Aarau Identifier: NCT00683293    
Other Study ID Numbers: KSA-RobHyst
First Posted: May 23, 2008    Key Record Dates
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:
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Postoperative Complications
Intraoperative Complications
Pathologic Processes