Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
Recruitment status was Not yet recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Total Abdominal Hysterectomy |
Procedure: Performing abdominal hysterectomy using gyrus electrocoagulation forceps |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy |
- Operating time, Blood loss, Post-operative pain [ Time Frame: 1 year ]
- Length of hospital stay, Cost of the procedure [ Time Frame: 1 year ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | August 2008 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00484835
| Contact: Marziya Kadir, MBBS | 613 95946666 | marziya@hotmail.com | |
| Contact: Jason Tan, MBBS, MRANZCG | 61409116446 | jasontan@iinet.net.au |
| Australia, Victoria | |
| Casey Hospital | Not yet recruiting |
| Melbourne, Victoria, Australia | |
| Dandenong Hospital | Not yet recruiting |
| Melbourne, Victoria, Australia | |
| Monash Medical Centre(Moorabin) | Not yet recruiting |
| Melbourne, Victoria, Australia | |
| Contact: Marziya Kadir, MBBS 613 95946666 marziya@hotmail.com | |
| Contact: Jason Tan, MBBS, MRANZCG 61409116446 jasontan@iinet.net.au | |
| Principal Investigator: | Marziya Kadir, MBBS | Southern Health |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00484835 History of Changes |
| Other Study ID Numbers: | Electrocoag Forceps in TAH |
| Study First Received: | June 8, 2007 |
| Last Updated: | August 7, 2007 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Southern Health:
|
Abdominal Hysterectomy Electrocoagulation forceps |
Electrosurgery Gyrus plasma open seal forceps Patients undergoing abdominal hysterectomy for various reasons |
ClinicalTrials.gov processed this record on February 26, 2015