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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Total Abdominal Hysterectomy	Procedure: Performing abdominal hysterectomy using gyrus electrocoagulation forceps	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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	September 2007
Estimated Study Completion Date :	August 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Operating time, Blood loss, Post-operative pain [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. Length of hospital stay, Cost of the procedure [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Marziya Kadir, MBBS	613 95946666	marziya@hotmail.com
Contact: Jason Tan, MBBS, MRANZCG	61409116446	jasontan@iinet.net.au

Locations

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

Sponsors and Collaborators

Southern Health

Gyrus ACMI

Investigators

Principal Investigator:	Marziya Kadir, MBBS	Southern Health

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00484835 History of Changes
Other Study ID Numbers:	Electrocoag Forceps in TAH
First Posted:	June 11, 2007
Last Update Posted:	August 8, 2007
Last Verified:	June 2007

Keywords provided by Southern Health:

Abdominal; Hysterectomy; Electrocoagulation forceps	Electrosurgery; Gyrus plasma open seal forceps; Patients undergoing abdominal hysterectomy for various reasons