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

NCT04397783 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-06-16

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Neoplasms
  • Parastomal Hernia
  • Colostomy Stoma

Interventions

PROCEDURE

construction of an end colostomy

longitudinal incision in the construction of an end colostomy

Sponsors & Collaborators

  • Hospital Donostia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2019-10-15
Completion
2022-04-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04397783 on ClinicalTrials.gov