Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

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

2007-04-30

Brief Summary

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The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.

Detailed Description

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Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent.

After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data.

A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above.

The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.

Conditions

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Vaginal 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 Vaginal hysterectomy with Harmonic Scalpel

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Any patient already on waitlist requiring vaginal hysterectomy

Exclusion Criteria

* No patient consent

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Jason J Tan, MBBS MRANZCOG

Role: PRINCIPAL_INVESTIGATOR

Southern Health

Locations

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Moorabin Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Central Contacts

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Jason J Tan, MBBS, MRANZCG

Role: CONTACT

[email protected]

+61409116446

Geoff Edwards, MBBS> FRANGCOG

Role: CONTACT

+61395946666

Facility Contacts

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Alison Fitz-Gerald, MBBS

Role: primary