Hernia Prevention in Stomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Schreinemacher, Academisch Ziekenhuis Maastricht
ClinicalTrials.gov Identifier:
NCT00907842
First received: May 21, 2009
Last updated: April 5, 2013
Last verified: April 2013

May 21, 2009
April 5, 2013
April 2010
February 2013   (final data collection date for primary outcome measure)
  • postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh) [ Time Frame: one year after placement ] [ Designated as safety issue: Yes ]
  • incisional herniation at the old stoma wound [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00907842 on ClinicalTrials.gov Archive Site
stoma complications (stenosis, bulging, prolapse, retraction, skin problems) [ Time Frame: two years after placement ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hernia Prevention in Stomas
Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study

Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.

The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Incisional Hernia
  • Parastomal Hernia
Device: Parietex Parastomal Mesh
mesh placed intraperitoneally around the stoma
Experimental: mesh placement
Intervention: Device: Parietex Parastomal Mesh

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with a life expectancy of at least one year
  • Temporary stoma formation
  • Signed informed consent
  • Elective surgery
  • Clean-contaminated abdomen

Exclusion Criteria:

  • American Society of Anaesthesiologists (ASA) score IV or above
  • Incapacitated adult or no signed informed consent
  • Emergency procedure
  • Contaminated or infected abdomen
  • Residual intraperitoneal mesh
  • Already injured part of the abdominal wall where the stoma will be sited
  • Contraindication to laparoscopy
  • Longterm use of corticosteroids and other immunosuppressive agents
  • Current antibiotic therapy
  • One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00907842
MEC09-2-052, NL27625.068.09
No
Marc Schreinemacher, Academisch Ziekenhuis Maastricht
Marc Schreinemacher
Not Provided
Study Director: Nicole Bouvy, MD, PhD Maastricht University Medical Centre
Principal Investigator: Marc Schreinemacher, MD Maastricht University Medical Centre
Academisch Ziekenhuis Maastricht
April 2013

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