Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial

Study Overview
=================
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.

Official Title
-----------------
Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy

Conditions
-----------------
Total Abdominal Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Performing abdominal hysterectomy using gyrus electrocoagulation forceps


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Performing abdominal hysterectomy using gyrus electrocoagulation forceps|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time, Blood loss, Post-operative pain |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay, Cost of the procedure |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal, Hysterectomy, Electrocoagulation forceps, Electrosurgery, Gyrus plasma open seal forceps, Patients undergoing abdominal hysterectomy for various reasons