HAVE: Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

• Sponsor: Southern Health (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00456170
• Collaborator: Johnson & Johnson (Industry)
• Enrollment: 60
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Hysterectomy	Procedure: Performing Vaginal hysterectomy with Harmonic Scalpel	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy
• Study Start Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Pain score []

2. Time to discharge []

3. Blood loss []

Secondary Outcome Measures

1. Cost []

2. Complications []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Any patient already on waitlist requiring vaginal hysterectomy

Exclusion Criteria:

• No patient consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moorabin Hospital	Melbourne	Victoria	Australia	8148

Sponsors and Collaborators

• Southern Health
• Johnson & Johnson

Investigators

• Principal Investigator: Jason J Tan, MBBS MRANZCOG, Southern Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00456170
• Other Study ID Numbers: Harmonic Vag Hyst
• First Posted: Apr 4, 2007
• Last Update Posted: Apr 4, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: Vaginal; Hysterectomy; Harmonic; Ligasure; Sutures; Modern; Patients undergoing vaginal hysterectomy for various reasons

Study Results

No Results Posted as of Apr 4, 2007