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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Kantonsspital Aarau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT00683293
First received: May 21, 2008
Last updated: June 23, 2009
Last verified: June 2009
History of Changes
  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
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: 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:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

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: November 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (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

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

No publications provided

Responsible Party: Dimitri Sarlos/ Vice Chairmain, Kantonspital Aarau/ Department of Gynecology & Obstetrics
ClinicalTrials.gov Identifier: NCT00683293     History of Changes
Other Study ID Numbers: KSA-RobHyst
Study First Received: May 21, 2008
Last Updated: June 23, 2009
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Intraoperative Complications
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013