Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Operating time, Blood loss, Post-operative pain [1 year]
Secondary Outcome Measures
- Length of hospital stay, Cost of the procedure [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Any patient already on waitlist in Southern Health for abdominal hysterectomy with suspected benign pathology
Exclusion Criteria:
- Patients without consent and/or with suspected malignant pathology
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Casey Hospital | Melbourne | Victoria | Australia | |
| 2 | Dandenong Hospital | Melbourne | Victoria | Australia | |
| 3 | Monash Medical Centre(Moorabin) | Melbourne | Victoria | Australia |
Sponsors and Collaborators
- Southern Health
- Gyrus ACMI
Investigators
- Principal Investigator: Marziya Kadir, MBBS, Southern Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Electrocoag Forceps in TAH