NCT00456170

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
Last Updated

April 4, 2007

Status Verified

April 1, 2007

First QC Date

April 3, 2007

Last Update Submit

April 3, 2007

Conditions

Vaginal Hysterectomy

Keywords

VaginalHysterectomyHarmonicLigasureSuturesModernPatients undergoing vaginal hysterectomy for various reasons

Outcome Measures

Primary Outcomes (3)

  • Pain score

  • Time to discharge

  • Blood loss

Secondary Outcomes (2)

  • Cost

  • Complications

Interventions

Performing Vaginal hysterectomy with Harmonic ScalpelPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient already on waitlist requiring vaginal hysterectomy

You may not qualify if:

  • No patient consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorabin Hospital

Melbourne, Victoria, 8148, Australia

Location

Study Officials

  • Jason J Tan, MBBS MRANZCOG

    Southern Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason J Tan, MBBS, MRANZCG

CONTACT

+61409116446jasontan@iinet.net.au

Geoff Edwards, MBBS> FRANGCOG

CONTACT

+61395946666

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 4, 2007

Study Start

April 1, 2007

Last Updated

April 4, 2007

Record last verified: 2007-04

Locations

AU(1)