Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial (HAVE)
Recruitment status was: Not yet recruiting
Procedure: Performing Vaginal hysterectomy with Harmonic Scalpel
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy|
- Pain score
- Time to discharge
- Blood loss
|Study Start Date:||April 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456170
|Melbourne, Victoria, Australia, 8148|
|Principal Investigator:||Jason J Tan, MBBS MRANZCOG||Southern Health|