Skip to main content
OpenTrials
Completed

NCT Number: NCT00683293

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

The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laparoscopic Technique no Switch to Open Duration of Surgery Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Aarau

Aarau, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional laparoscopic hysterectomy

Procedure

Removal of uterus via standard laparoscopic techniques

Other names: - Minimal invasive hysterectomy,, - Laparoscopic removal of uterus,, - Minimal invasive removal of uterus

Robot-assisted (Da Vinci®) laparoscopic hysterectomy

Procedure

Removal of uterus by robot-assisted laparoscopic technique

Other names: - Robot-assisted(Da Vinci®)laparoscopic hysterectomy, - Robot-assisted minimal invasive hysterectomy

Primary outcomes

  1. Duration of Surgery

    Time frame: after surgey

    •Mean Time to complete surgery from cut to suture

Secondary outcomes

  1. Complications

    Time frame: up to 2 weeks

Sponsors and collaborators

Lead sponsor

Kantonsspital Aarau

Other

Registry information

Official study title

Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 23, 2008
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.