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

This study is currently recruiting participants. (see Contacts and Locations)
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

August 9, 2011
August 9, 2011
December 2009
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Evaluation of a New Surgical Method for the Repair of Large Ventral Hernia
Randomized Controlled Study of a New Surgical Method for the Repair of Large Ventral Hernia

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Ventral Hernia
  • Postoperative Pain
  • 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.
  • Procedure: Ventral hernia repair using mesh
    25 patients will undergo ventral hernia repair / abdominal wall reconstruction using mesh.
  • 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.
    Intervention: Procedure: Ventral hernia repair using full thickness skin graft
  • Experimental: Hernia repair using Mesh
    25 patients will undergo ventral hernia repair / abdominal wall reconstruction using mesh.
    Intervention: Procedure: Ventral hernia repair using mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Karin Strigård, MD +46 (8) 5858 0000 karin.strigard@ki.se
Contact: Leonard Clay, MD +46 (8) 5177 0000 leonard.clay@ki.se
Sweden
 
NCT01413412
2009/227-31/3
No
Leonard Clay, Karolinska Institutet CLINTEC
Karolinska Institutet
Not Provided
Study Director: Karin Strigård, MD Karolinska Institute CLINTEC
Principal Investigator: Leonard Clay, MD Karolinska Institute CLINTEC
Study Chair: Ulf Gunnarsson, MD Karolinska Institute CLINTEC
Karolinska Institutet
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP