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

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ClinicalTrials.gov Identifier: NCT00683293
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
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.


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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Publications of Results:
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 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:
Postoperative Complications
Intraoperative Complications
Pathologic Processes