Parastomal Hernia Clinical Trial
Official title:
Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia After Laparoscopic Abdominoperineal Resection
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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