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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456170
Recruitment Status : Unknown
Verified April 2007 by Southern Health.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2007
Last Update Posted : April 4, 2007
Johnson & Johnson
Information provided by:
Southern Health

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 Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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 : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Primary Outcome Measures :
  1. Pain score
  2. Time to discharge
  3. Blood loss

Secondary Outcome Measures :
  1. Cost
  2. Complications

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Any patient already on waitlist requiring vaginal hysterectomy

Exclusion Criteria:

  • No patient consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456170

Contact: Jason J Tan, MBBS, MRANZCG +61409116446
Contact: Geoff Edwards, MBBS> FRANGCOG +61395946666

Australia, Victoria
Moorabin Hospital Not yet recruiting
Melbourne, Victoria, Australia, 8148
Contact: Alison Fitz-Gerald, MBBS    +61417 354 743   
Sponsors and Collaborators
Southern Health
Johnson & Johnson
Principal Investigator: Jason J Tan, MBBS MRANZCOG Southern Health Identifier: NCT00456170     History of Changes
Other Study ID Numbers: Harmonic Vag Hyst
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007

Keywords provided by Southern Health:
Patients undergoing vaginal hysterectomy for various reasons