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

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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
Endpoint Classification: Efficacy Study
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:


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

Genders 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
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
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   
Dandenong Hospital Not yet recruiting
Melbourne, Victoria, Australia
Casey Hospital Not yet recruiting
Melbourne, Victoria, Australia
Sponsors and Collaborators
Southern Health
Gyrus ACMI
Investigators
Principal Investigator: Marziya Kadir, MBBS Southern Health
  More Information

No publications provided

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
Health Authority: Australia: National Health and Medical Research Council

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 April 17, 2014