Vaginal Hysterectomy Clinical Trial
Official title:
Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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