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

Total Abdominal Hysterectomy Clinical Trial

Official title:

Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00484835
• Other study ID #: Electrocoag Forceps in TAH
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 8, 2007
• Last updated: August 7, 2007
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: June 2007
• Source: Southern Health
• Contact: Marziya Kadir, MBBS
• Phone: 613 95946666
• Email: marziya[@]hotmail.com
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Abdominal Hysterectomy

Intervention

Procedure:
• Performing abdominal hysterectomy using gyrus electrocoagulation forceps

Locations

Country	Name	City	State
Australia	Casey Hospital	Melbourne	Victoria
Australia	Dandenong Hospital	Melbourne	Victoria
Australia	Monash Medical Centre(Moorabin)	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Southern Health	Gyrus ACMI

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating time, Blood loss, Post-operative pain		1 year
Secondary	Length of hospital stay, Cost of the procedure		1 year