Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ". DESIGN: Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio. POPULATION: Patients undergoing colorectal cancer surgery a definitive end colostomy. OBJECTIVES: The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery. Secondary objectives are: 1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery. 2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. 4\) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale). DESCRIPTION OF THE INTERVENTION: An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia. DURATION OF THE STUDY: The expected duration of the study is 3 years. PATIENT FOLLOW UP TIME: The planned follow-up time is 2 years. EXPECTED RECRUITMENT TIME: 12 months.

Sex

All

Minimum age

18 Years

Maximum age

85 Years

Inclusion Criteria:

* Patients undergoing surgery for colorectal cancer undergoing definitive end colostomy.
* Age ≥ 18 years and \<85 years.
* Any type of tumor, any T, N, M0.
* Consent signed by the patient and by the researcher.

Exclusion Criteria:

* no colostomy, not end stoma.
* Inflammatory bowel disease with anatomopathological confirmation.
* Patients with previous incisional hernias or carriers of meshes except inguinal hernioplasties.
* Patients with previous stoma.
* Inability to read or understand any of the languages of informed consent.
* Emergency surgery.
* Psychiatric diseases, addictions or any disorder that prevents the compression of informed consent.
* Extraction of the piece by colostomy hole.
* Colostomies not previously marked by specialized stomatherapist.