NCT00572962

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

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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
19 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

6.6 years

First QC Date

December 11, 2007

Last Update Submit

December 15, 2022

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 (1)

1

EXPERIMENTAL

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Procedure: use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Interventions

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repairPROCEDURE

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

1

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 Publications (1)

  • Berrevoet F, Tollens T, Berwouts L, Bertrand C, Muysoms F, De Gols J, Meir E, De Backer A. A belgian multicenter prospective observational cohort study shows safe and efficient use of a composite mesh with incorporated oxidized regenerated cellulose in laparoscopic ventral hernia repair. Acta Chir Belg. 2014 Jul-Aug;114(4):233-8.

    PMID: 26021417DERIVED

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 13, 2007

Study Start

January 1, 2008

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

BE(1)