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

NCT ID: NCT00484835

Last Updated: 2007-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Total Abdominal Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Performing abdominal hysterectomy using gyrus electrocoagulation forceps

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gyrus ACMI

INDUSTRY

Sponsor Role collaborator

Southern Health

OTHER

Sponsor Role lead

Principal Investigators

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Marziya Kadir, MBBS

Role: PRINCIPAL_INVESTIGATOR

Southern Health

Locations

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Casey Hospital

Melbourne, Victoria, Australia

Site Status

Dandenong Hospital

Melbourne, Victoria, Australia

Site Status

Monash Medical Centre(Moorabin)

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Central Contacts

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Marziya Kadir, MBBS

Role: CONTACT

613 95946666

Jason Tan, MBBS, MRANZCG

Role: CONTACT

61409116446

Facility Contacts

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Marziya Kadir, MBBS

Role: primary

613 95946666

Jason Tan, MBBS, MRANZCG

Role: backup

61409116446

Other Identifiers

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Electrocoag Forceps in TAH

Identifier Type: -

Identifier Source: org_study_id