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Hernia Prevention in Stomas

This study has been completed.
Information provided by (Responsible Party):
Marc Schreinemacher, Academisch Ziekenhuis Maastricht Identifier:
First received: May 21, 2009
Last updated: April 5, 2013
Last verified: April 2013
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: Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by Marc Schreinemacher, 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 ]
  • incisional herniation at the old stoma wound [ Time Frame: two years ]

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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00907842

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

Responsible Party: Marc Schreinemacher, investigator, Academisch Ziekenhuis Maastricht Identifier: NCT00907842     History of Changes
Other Study ID Numbers: MEC09-2-052
Study First Received: May 21, 2009
Last Updated: April 5, 2013

Keywords provided by Marc Schreinemacher, Academisch Ziekenhuis Maastricht:

Additional relevant MeSH terms:
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes processed this record on September 21, 2017