Clinical trial NCT00907842: Hernia Prevention in Stomas
Official title: Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Parastomal Hernia
Keywords: stoma
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
First posted: 2009-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
timeFrame: one year after placement
measure: incisional herniation at the old stoma wound
timeFrame: two years
Secondary outcomes:
measure: stoma complications (stenosis, bulging, prolapse, retraction, skin problems)
timeFrame: two years after placement
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: Nicole Bouvy, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Centre
name: Marc Schreinemacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.
citation: Cingi A, Cakir T, Sever A, Aktan AO. Enterostomy site hernias: a clinical and computerized tomographic evaluation. Dis Colon Rectum. 2006 Oct;49(10):1559-63. doi: 10.1007/s10350-006-0681-4.