Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial (HAVE)
|ClinicalTrials.gov Identifier: NCT00456170|
Recruitment Status : Unknown
Verified April 2007 by Southern Health.
Recruitment status was: Not yet recruiting
First Posted : April 4, 2007
Last Update Posted : April 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Hysterectomy||Procedure: Performing Vaginal hysterectomy with Harmonic Scalpel||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy|
|Study Start Date :||April 2007|
- Pain score
- Time to discharge
- Blood loss
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456170
|Contact: Jason J Tan, MBBS, MRANZCGemail@example.com|
|Contact: Geoff Edwards, MBBS> FRANGCOG||+61395946666|
|Moorabin Hospital||Not yet recruiting|
|Melbourne, Victoria, Australia, 8148|
|Contact: Alison Fitz-Gerald, MBBS +61417 354 743 firstname.lastname@example.org|
|Principal Investigator:||Jason J Tan, MBBS MRANZCOG||Southern Health|