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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
History of Changes
  Purpose

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.


Condition Intervention
Incisional Hernia
Parastomal Hernia
 Device: Parietex Parastomal Mesh

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Academisch Ziekenhuis Maastricht:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • stoma complications (stenosis, bulging, prolapse, retraction, skin problems) [ Time Frame: two years after placement ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mesh placement Device: Parietex Parastomal Mesh
mesh placed intraperitoneally around the stoma

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907842

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6200 AZ
Sponsors and Collaborators
Marc Schreinemacher
Investigators
Study Director: Nicole Bouvy, MD, PhD Maastricht University Medical Centre
Principal Investigator: Marc Schreinemacher, MD Maastricht University Medical Centre
  More Information

Publications:

Responsible Party: Marc Schreinemacher, investigator, Academisch Ziekenhuis Maastricht
ClinicalTrials.gov Identifier: NCT00907842     History of Changes
Other Study ID Numbers: MEC09-2-052, NL27625.068.09
Study First Received: May 21, 2009
Last Updated: April 5, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Ziekenhuis Maastricht:
stoma

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013