Hernia Prevention in Stomas

Marc Schreinemacher

Status: Completed

Conditions: Incisional Hernia; Parastomal Hernia

Treatments: Device: Parietex Parastomal Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00907842

NL27625.068.09

MEC09-2-052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

mesh placement

Experimental group

Treatment:

Device: Parietex Parastomal Mesh