Clinical trial NCT01722565: Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
Official title: Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parastomal Hernia
Keywords: Parastomal hernias
Tolerance of lightweight meshes
laparoscopic abdominoperineal resection
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction: parastomal hernia (PH) is a frequent complication after an ostomy, despite the many prevention and treatment techniques that have been described. Since the introduction of laparoscopy, the frequency of PH is even higher than in open surgery. This type of hernia remains a surgical problem of considerable importance, requiring significant consumption of public health and economic resources, and representing a major alteration of the quality of life of these patients.

Objective: to evaluate the effectiveness of the insertion of a prosthesis to prevent PH in elective surgery for laparoscopic abdominoperineal resection.

Methodology: prospective, multidisciplinary, multi-center randomized controlled study. Control group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection. Study group: Rectal neoplasms undergoing elective surgery for laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25). Sample size was calculated based on a proportion of parastomal hernia of 65% in the control group and 15% in the study group. With an α risk =0.05 and 1- β= 0.8, 28 patients are required, 14 per group. Estimating a drop-out rate of 10%, the final number will be 32 patients. The efficacy will be evaluated clinically at six months and abdominal CT will be performed at 12 months along with another clinical evaluation.


Eligibility criteria: 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

Primary outcomes:
measure: The reduction in the incidence of Parastomal Hernia after the mesh placement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Universitaria Parc Tauli
state: Barcelona
Study officials:
affiliation: Corporacion Sanitaria Universitaria Parc Tauli
name: Xavier Serra-Aracil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebron
name: Manuel Lopez-Cano, MD
role: PRINCIPAL_INVESTIGATOR
References: