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

August 7, 2007 updated by: Southern Health

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

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.

Study Overview

Status

Unknown

Conditions

Total Abdominal Hysterectomy

Intervention / Treatment

Procedure: Performing abdominal hysterectomy using gyrus electrocoagulation forceps

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 Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Victoria
  - Melbourne, Victoria, Australia
    - Casey Hospital
  - Melbourne, Victoria, Australia
    - Dandenong Hospital
  - Melbourne, Victoria, Australia
    - Monash Medical Centre(Moorabin)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay, Cost of the procedure Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Health

Collaborators

Gyrus ACMI

Investigators

Principal Investigator: Marziya Kadir, MBBS, Southern Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

August 1, 2008

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria