NCT00484835

Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Southern Health · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Total Abdominal Hysterectomy

Interventions

Type	Name	Description
PROCEDURE	Performing abdominal hysterectomy using gyrus electrocoagulation forceps

Timeline

• Start date: 2007-09-01
• Completion: 2008-08-01
• First posted: 2007-06-11
• Last updated: 2007-08-08

Locations

3 sites across 1 country: Australia