Hernia Prevention in Stomas

Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00907842

Enrollment

Registered

2009-05-25

Start date

2010-04-30

Completion date

2013-04-30

Last updated

2013-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia, Parastomal Hernia

Keywords

stoma

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.

Interventions

DEVICEParietex Parastomal Mesh

mesh placed intraperitoneally around the stoma

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)	one year after placement
incisional herniation at the old stoma wound	two years

Secondary

Measure	Time frame
stoma complications (stenosis, bulging, prolapse, retraction, skin problems)	two years after placement

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026