Skip to main content
Clinical Trials/NCT00484835
NCT00484835
Unknown
Phase 1

Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy

Southern Health3 sites in 1 country60 target enrollmentSeptember 2007

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Total Abdominal Hysterectomy
Sponsor
Southern Health
Enrollment
60
Locations
3
Primary Endpoint
Operating time, Blood loss, Post-operative pain
Last Updated
18 years ago

Overview

Brief Summary

The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp & suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.

Detailed Description

Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps \& the other group with the traditional clamp \& suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent. The researcher will collect relevant data including age of patient, medical \& surgical history and data relating to both the primary \& secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay \& cost. A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above. Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal \& cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
August 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Southern Health

Eligibility Criteria

Inclusion Criteria

  • Any patient already on waitlist in Southern Health for abdominal hysterectomy with suspected benign pathology

Exclusion Criteria

  • Patients without consent and/or with suspected malignant pathology

Outcomes

Primary Outcomes

Operating time, Blood loss, Post-operative pain

Time Frame: 1 year

Secondary Outcomes

  • Length of hospital stay, Cost of the procedure(1 year)

Study Sites (3)

Loading locations...

Similar Trials