NCT00484835

Brief Summary

The Hypothesis of this study is that performing total abdominal hysterectomy using the newer electrocoagulation forceps, specifically, the gyrus open seal forceps, curved, compared to the traditional clamp \& suture technique will result in reduction of operating time, intra-operative blood loss, post-operative pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

June 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 8, 2007

Status Verified

June 1, 2007

First QC Date

June 8, 2007

Last Update Submit

August 7, 2007

Conditions

Keywords

AbdominalHysterectomyElectrocoagulation forcepsElectrosurgeryGyrus plasma open seal forcepsPatients undergoing abdominal hysterectomy for various reasons

Outcome Measures

Primary Outcomes (1)

  • Operating time, Blood loss, Post-operative pain

    1 year

Secondary Outcomes (1)

  • Length of hospital stay, Cost of the procedure

    1 year

Interventions

Eligibility Criteria

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

You may qualify if:

  • Any patient already on waitlist in Southern Health for abdominal hysterectomy with suspected benign pathology

You may not qualify if:

  • Patients without consent and/or with suspected malignant pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Casey Hospital

Melbourne, Victoria, Australia

Location

Dandenong Hospital

Melbourne, Victoria, Australia

Location

Monash Medical Centre(Moorabin)

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Marziya Kadir, MBBS

    Southern Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marziya Kadir, MBBS

CONTACT

Jason Tan, MBBS, MRANZCG

CONTACT

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

June 8, 2007

First Posted

June 11, 2007

Study Start

September 1, 2007

Study Completion

August 1, 2008

Last Updated

August 8, 2007

Record last verified: 2007-06

Locations