Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial (HAVE)
Recruitment status was Not yet recruiting
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.
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
|Contact: Jason J Tan, MBBS, MRANZCGfirstname.lastname@example.org|
|Contact: Geoff Edwards, MBBS> FRANGCOG||+61395946666|
|Moorabin Hospital||Not yet recruiting|
|Melbourne, Victoria, Australia, 8148|
|Contact: Alison Fitz-Gerald, MBBS +61417 354 743 email@example.com|
|Principal Investigator:||Jason J Tan, MBBS MRANZCOG||Southern Health|