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Use of a Mesh to Prevent Parastomal Hernia

Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00691860
Enrollment
54
Registered
2008-06-06
Start date
2006-04-30
Completion date
2008-02-29
Last updated
2015-09-15

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

Conditions

Parastomal Hernia

Keywords

Parastomal hernias, Tolerance of lightweight meshes, Paracolostomy hernias, Peristomal hernias

Brief summary

Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity

Interventions

DEVICEMesh (Ultrapro ®)

In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy

PROCEDUREConventional sigmoid end colostomy

Patients receiving conventional sigmoid end colostomy, without mesh

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum, * Aged over 18, * Charlson comorbidity index below 7 * Elective surgery * Radical surgery

Exclusion criteria

* Loop colostomies, * Emergency surgery, * Body mass index above 35 kg/sq.m., * Palliative surgery, * Hepatic cirrhosis, * Severe COPD (requiring home oxygen treatment), * Corticoid treatment

Design outcomes

Primary

MeasureTime frame
the reduction in the incidence of Parastomal Hernia after the mesh placement6 months

Outcome results

None listed

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