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

June 8, 2007
August 7, 2007
September 2007
Not Provided
Operating time, Blood loss, Post-operative pain [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00484835 on ClinicalTrials.gov Archive Site
Length of hospital stay, Cost of the procedure [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Total Abdominal Hysterectomy
Procedure: Performing abdominal hysterectomy using gyrus electrocoagulation forceps
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
August 2008
Not Provided

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
Female
Not Provided
Yes
Contact: Marziya Kadir, MBBS 613 95946666 marziya@hotmail.com
Contact: Jason Tan, MBBS, MRANZCG 61409116446 jasontan@iinet.net.au
Australia
 
NCT00484835
Electrocoag Forceps in TAH
Yes
Not Provided
Southern Health
Gyrus ACMI
Principal Investigator: Marziya Kadir, MBBS Southern Health
Southern Health
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP