Clinical trial NCT00484835: Are Sutures Required in Total Abdominal Hysterectomy? A Randomised Control Trial
Official title: Randomised Control Trial Comparing Hysterectomy Using Electrocoagulation Forceps With the Traditional Clamp & Suture Technique of Richardson Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Total Abdominal Hysterectomy
Keywords: Abdominal
Hysterectomy
Electrocoagulation forceps
Electrosurgery
Gyrus plasma open seal forceps
Patients undergoing abdominal hysterectomy for various reasons
Lead sponsor: Southern Health
Sponsor class: OTHER
Collaborators: name: Gyrus ACMI
First posted: 2007-06-11
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Operating time, Blood loss, Post-operative pain
timeFrame: 1 year
Secondary outcomes:
measure: Length of hospital stay, Cost of the procedure
timeFrame: 1 year
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Casey Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Dandenong Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre(Moorabin)
state: Victoria
Study officials:
affiliation: Southern Health
name: Marziya Kadir, MBBS
role: PRINCIPAL_INVESTIGATOR
References: