Use of a Mesh to Prevent Parastomal Hernia

Parastomal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691860
• Other study ID #: CSPT-SerraA-01
• Status: Completed
• Phase: N/A
• First received: June 4, 2008
• Last updated: September 14, 2015
• Start date: April 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2008
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Device:
• Mesh (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

Procedure:
• Conventional sigmoid end colostomy
Patients receiving conventional sigmoid end colostomy, without mesh

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the reduction in the incidence of Parastomal Hernia after the mesh placement		6 months