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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2007 by Southern Health.
Recruitment status was: Not yet recruiting

Sponsor:

Collaborator:

Gyrus ACMI

Information provided by:

Southern Health

ClinicalTrials.gov Identifier:

NCT00484835

First received: June 8, 2007

Last updated: August 7, 2007

Last verified: June 2007

History of Changes

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 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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy

U.S. FDA Resources

Further study details as provided by Southern Health:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484835

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


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

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 June 22, 2017

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