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Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection


Phase 4
18 Years
90 Years
Open (Enrolling)
Both
Parastomal Hernia

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Trial Information

Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection


Inclusion Criteria:



- Patients of either sex intervened electively for colorectal surgery (rectal cancer)
in whom definitive colostomy is indicated after laparoscopic abdominoperineal
amputation.

- Life expectancy above 12 months

Exclusion Criteria:

- - Patients with allergy or intolerance of the compounds in the mesh

- Carriers of prosthetic meshes in the area of the ostomy

- Patients electively intervened for colorectal surgery (neo de reco) in whom
definitive colostomy is indicated after abdominoperineal amputation but not via a
laparoscopic approach.

- Cirrhotic patients

- Patients with life expectancy below 12 months due to underlying disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/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:

12 months

Safety Issue:

Yes

Principal Investigator

Xavier Serra-Aracil, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Corporacion Sanitaria Universitaria Parc Tauli

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

LAP-APR-2012-028

NCT ID:

NCT01722565

Start Date:

January 2012

Completion Date:

June 2014

Related Keywords:

  • Parastomal Hernia
  • Parastomal hernias
  • Tolerance of lightweight meshes
  • laparoscopic abdominoperineal resection
  • Hernia

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