Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 11:14 AM
Study NCT ID:
NCT00484835
Status:
UNKNOWN
Last Update Posted:
2007-08-08
First Post:
2007-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
Sponsor:
Southern Health
Organization:
Study Overview
Official Title:
Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy
Status:
UNKNOWN
Status Verified Date:
2007-06
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:
None
Brief Summary:
The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp \& suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.
Detailed Description:
Patients booked for total abdominal hysterectomy in Southern Health will be offered participation in the trial, and randomised to two groups: one group undergoing the procedure with the gyrus forceps \& the other group with the traditional clamp \& suture method. Each patient will receive detailed information regarding the study both in document form as well as verbally by the Gynaecology doctors in the pre-admission clinic prior to obtaining consent.
The researcher will collect relevant data including age of patient, medical \& surgical history and data relating to both the primary \& secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay \& cost.
A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.
Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal \& cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.
The researcher will collect relevant data including age of patient, medical \& surgical history and data relating to both the primary \& secondary outcome measures, which include length of operation, intra-operative blood loss,post-operative pain measures as well as length of hospital stay \& cost.
A qualified statistician will perform power calculations and analyse the data collected, looking at the outcome measures mentioned above.
Electrical surgery has been used extensively in surgery, especially in laparoscopic surgery, and the use of these newer electrocoagulation forceps that can simultaneously haemostatically seal \& cut tissue is again well established in laparoscopic surgery but only more recently introduced to open surgical procedures. To date, except for 1 pilot study, there are no randomised control trials that confirm the proposed benefits of these newer device in abdominal hysterectomy.
Study Oversight
Has Oversight DMC:
True
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?: