Evaluation of a New Surgical Method for the Repair of Large Ventral Hernia

This study is currently recruiting participants.
Verified January 2010 by Karolinska Institutet
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01413412
First received: August 9, 2011
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.


Condition Intervention
Ventral Hernia
Postoperative Pain
Procedure: Ventral hernia repair using full thickness skin graft
Procedure: Ventral hernia repair using mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of a New Surgical Method for the Repair of Large Ventral Hernia

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Rate of complication [ Time Frame: 3 year period of follow-up ] [ Designated as safety issue: No ]
    Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation.


Secondary Outcome Measures:
  • Ventral Hernia Pain Questionnaire (VHPQ) [ Time Frame: 1 year period of follow-up ] [ Designated as safety issue: No ]
    All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain.

  • Abdominal wall function [ Time Frame: 3 year period of follow up ] [ Designated as safety issue: No ]
    All subjects will undergo testing of abdominal wall function and strength using the Biodex.


Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hernia repair using full thickness skin graft
25 patients will undergo ventral hernia repair / abdominal wall reconstruction using autologous onlay full thickness skin grafts.
Procedure: Ventral hernia repair using full thickness skin graft
25 patients will undergo ventral hernia / abdominal wall reconstruction using autologous onlay full thickness skin grafts.
Experimental: Hernia repair using Mesh
25 patients will undergo ventral hernia repair / abdominal wall reconstruction using mesh.
Procedure: Ventral hernia repair using mesh
25 patients will undergo ventral hernia repair / abdominal wall reconstruction using mesh.

Detailed Description:

Patients with giant (>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ventral hernia > 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.

Exclusion Criteria:

  • < 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413412

Contacts
Contact: Karin Strigård, MD +46 (8) 5858 0000 karin.strigard@ki.se
Contact: Leonard Clay, MD +46 (8) 5177 0000 leonard.clay@ki.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Leonard Clay, MD    +46 (8) 5177 0000    leonard.clay@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Director: Karin Strigård, MD Karolinska Institute CLINTEC
Principal Investigator: Leonard Clay, MD Karolinska Institute CLINTEC
Study Chair: Ulf Gunnarsson, MD Karolinska Institute CLINTEC
  More Information

No publications provided

Responsible Party: Leonard Clay, Karolinska Institutet CLINTEC
ClinicalTrials.gov Identifier: NCT01413412     History of Changes
Other Study ID Numbers: 2009/227-31/3
Study First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: Sweden: Stockholms läns landsting

Keywords provided by Karolinska Institutet:
Ventral Hernia
Postoperative Pain
Ventral Hernia Pain Questionnaire
Postoperative Abdominal wall and muscle function
Biodex

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014