Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

Vaginal Hysterectomy Clinical Trial

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Official title:

Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00456170
• Other study ID #: Harmonic Vag Hyst
• Status: Not yet recruiting
• Phase: Phase 1
• First received: April 3, 2007
• Last updated: April 3, 2007
• Start date: April 2007

Study information

• Verified date: April 2007
• Source: Southern Health
• Contact: Jason J Tan, MBBS, MRANZCG
• Phone: +61409116446
• Email: jasontan[@]iinet.net.au
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient already on waitlist requiring vaginal hysterectomy

Exclusion Criteria:

• No patient consent

Study Design

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

Related Conditions & MeSH terms

• Vaginal Hysterectomy

Intervention

Procedure:
• Performing Vaginal hysterectomy with Harmonic Scalpel

Locations

Country	Name	City	State
Australia	Moorabin Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Southern Health	Johnson & Johnson

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score
Primary	Time to discharge
Primary	Blood loss
Secondary	Cost
Secondary	Complications