NCT00311935

Brief Summary

This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group. The overall financial costs of each repair will also be compared.

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
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

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, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

First QC Date

April 5, 2006

Last Update Submit

February 2, 2009

Conditions

Hernia, Inguinal

Keywords

HerniaInguinalGroinLaparoscopicOpenAbdominal wall

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence rates at 2 years post surgery.

Secondary Outcomes (7)

  • Complication rates.

  • Duration of procedure.

  • Cost of equipment use.

  • Rate of conversion to open procedure

  • Length of hospital stay.

  • +2 more secondary outcomes

Interventions

method of hernia repairPROCEDURE

Eligibility Criteria

Age15 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male \<60yrs with primary inguinal hernia

You may not qualify if:

  • Recurrent hernia
  • Bilateral hernia
  • Non-reducible/obstructed hernia
  • Previous lower abdominal surgery/radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waitemata District Health Board

Auckland, New Zealand

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Rodgers, MBCHB,FRACS

    Waitemata District Health Board

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Rodgers, MBCHB, FRACS

CONTACT

+64 9 486 8920michael.rodgers@waitematadhb.govt.nz

Hisham Hammodat, MBCHB, FRACS

CONTACT

+64 9 486 8920hisham.hammodat@waitematadhb.govt.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 6, 2006

Study Start

April 1, 2006

Study Completion

May 1, 2010

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

NZ(1)