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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Southern Health.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Southern Health
ClinicalTrials.gov Identifier:
NCT00456170
First received: April 3, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention Phase
Vaginal Hysterectomy
Procedure: Performing Vaginal hysterectomy with Harmonic Scalpel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy

Resource links provided by NLM:


Further study details as provided by Southern Health:

Primary Outcome Measures:
  • Pain score
  • Time to discharge
  • Blood loss

Secondary Outcome Measures:
  • Cost
  • Complications

Estimated Enrollment: 60
Study Start Date: April 2007
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient already on waitlist requiring vaginal hysterectomy

Exclusion Criteria:

  • No patient consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456170

Contacts
Contact: Jason J Tan, MBBS, MRANZCG +61409116446 jasontan@iinet.net.au
Contact: Geoff Edwards, MBBS> FRANGCOG +61395946666

Locations
Australia, Victoria
Moorabin Hospital Not yet recruiting
Melbourne, Victoria, Australia, 8148
Contact: Alison Fitz-Gerald, MBBS    +61417 354 743    fitzali@gmail.com   
Sponsors and Collaborators
Southern Health
Johnson & Johnson
Investigators
Principal Investigator: Jason J Tan, MBBS MRANZCOG Southern Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00456170     History of Changes
Other Study ID Numbers: Harmonic Vag Hyst
Study First Received: April 3, 2007
Last Updated: April 3, 2007
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Southern Health:
Vaginal
Hysterectomy
Harmonic
Ligasure
Sutures
Modern
Patients undergoing vaginal hysterectomy for various reasons

ClinicalTrials.gov processed this record on November 20, 2014