NCT00573105

Brief Summary

  • at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
  • with or without anchoring transparietal sutures or double crown technique

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

2.8 years

First QC Date

December 11, 2007

Last Update Submit

January 25, 2011

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

    after 1 year

Secondary Outcomes (4)

  • morbidity rate

    perioperative

  • quality of life

    after 1 year

  • postoperative pain

    within 1 week

  • long term complication rate

    after 1 year

Study Arms (2)

1

EXPERIMENTAL

Laparoscopic Ventral hernia repair by heavy weight mesh

Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh

2

EXPERIMENTAL

Laparoscopic Ventral hernia repair by lighter weight mesh

Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh

Interventions

Laparoscopic Ventral hernia repair by heavy weight meshPROCEDURE

Laparoscopic Ventral hernia repair by heavy weight mesh

1
Laparoscopic Ventral hernia repair by lighter weight meshPROCEDURE

Laparoscopic Ventral hernia repair by lighter weight mesh

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent from the patient or his/her legal representative
  • ventral hernia requiring elective surgical repair

You may not qualify if:

  • no written informed consent
  • 'hostile' abdomen; open abdomen treatment
  • contraindication to pneumoperitoneum
  • emergency surgery (incarcerated hernia)
  • parastomal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Berrevoet, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 13, 2007

Study Start

February 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations

BE(1)