NCT00456170

Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy

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

Summary

The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.

Detailed description

Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent. After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data. A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above. The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.

Conditions

• Vaginal Hysterectomy

Interventions

Type	Name	Description
PROCEDURE	Performing Vaginal hysterectomy with Harmonic Scalpel

Timeline

• Start date: 2007-04-01
• First posted: 2007-04-04
• Last updated: 2007-04-04

Locations

1 site across 1 country: Australia