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


N/A
18 Years
N/A
Not Enrolling
Both
Parastomal Hernia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

the reduction in the incidence of Parastomal Hernia after the mesh placement

Outcome Time Frame:

6 months

Principal Investigator

Salvador Navarro-Soto, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Corporacio Sanitaria Parc Tauli

Authority:

Spain: Ethics Committee

Study ID:

CSPT-SerraA-01

NCT ID:

NCT00691860

Start Date:

April 2006

Completion Date:

February 2008

Related Keywords:

  • Parastomal Hernia
  • Parastomal hernias
  • Tolerance of lightweight meshes
  • Paracolostomy hernias
  • Peristomal hernias
  • Hernia

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