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

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ClinicalTrials.gov Identifier: NCT00484835
Recruitment Status : Unknown
Verified June 2007 by Southern Health.
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2007
Last Update Posted : August 8, 2007
Sponsor:
Collaborator:
Gyrus ACMI
Information provided by:
Southern Health

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arms and Interventions
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Outcome Measures
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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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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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ClinicalTrials.gov Identifier: NCT00484835     History of Changes
Other Study ID Numbers: Electrocoag Forceps in TAH
First Posted: June 11, 2007    Key Record Dates
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