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Hernia Prevention in Stomas

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ClinicalTrials.gov Identifier: NCT00907842
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
Marc Schreinemacher, Academisch Ziekenhuis Maastricht

Brief Summary:
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 or disease Intervention/treatment
Incisional Hernia Parastomal Hernia Device: Parietex Parastomal Mesh

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : April 2010
Primary Completion Date : February 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: mesh placement Device: Parietex Parastomal Mesh
mesh placed intraperitoneally around the stoma



Primary Outcome Measures :
  1. 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 ]
  2. incisional herniation at the old stoma wound [ Time Frame: two years ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Marc Schreinemacher, Academisch Ziekenhuis Maastricht:
stoma

Additional relevant MeSH terms:
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes