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Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00456170
Acronym
HAVE
Enrollment
60
Registered
2007-04-04
Start date
2007-04-30
Completion date
Unknown
Last updated
2007-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Hysterectomy

Keywords

Vaginal, Hysterectomy, Harmonic, Ligasure, Sutures, Modern, Patients undergoing vaginal hysterectomy for various reasons

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.

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.

Interventions

PROCEDUREPerforming Vaginal hysterectomy with Harmonic Scalpel

Sponsors

Johnson & Johnson
CollaboratorINDUSTRY
Southern Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Any patient already on waitlist requiring vaginal hysterectomy

Exclusion criteria

* No patient consent

Design outcomes

Primary

MeasureTime frame
Pain score
Time to discharge
Blood loss

Secondary

MeasureTime frame
Cost
Complications

Countries

Australia

Contacts

Primary ContactJason J Tan, MBBS, MRANZCG
jasontan@iinet.net.au+61409116446
Backup ContactGeoff Edwards, MBBS> FRANGCOG
+61395946666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026