Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456170
Status:
UNKNOWN
Last Update Posted:
2007-04-04
First Post:
2007-04-03
Brief Title:
Are Sutures Required for Vaginal Hysterectomy A Randomized Controlled Trial
Sponsor:
Southern Health
Organization:
Southern Health
Study Overview
Official Title:
Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HAVE
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None