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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitri Sarlos, Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT00683293
First received: May 21, 2008
Last updated: March 11, 2014
Last verified: March 2014
  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: 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 Kantonsspital Aarau:

Primary Outcome Measures:
  • Duration of Surgery [ Time Frame: after surgey ] [ Designated as safety issue: No ]
    •Mean Time to complete surgery from cut to suture


Secondary Outcome Measures:
  • Complications [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 21, 2008
Results First Received: November 12, 2013
Last Updated: March 11, 2014
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 October 21, 2014