NCT04397783: LONGCROSS

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

Status unknown NA Last updated 16 June 2020

What this trial tests

NA trial testing construction of an end colostomy in Colorectal Neoplasms in 42 participants. Status unknown.

Timeline

15 April 2019

Primary endpoint
15 October 2019

15 April 2022

Quick facts

Lead sponsor	Hospital Donostia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	42
Start date	15 April 2019
Primary completion	15 October 2019
Estimated completion	15 April 2022
Sites	2 locations across Spain

Drugs / interventions tested

• construction of an end colostomy

Conditions studied

• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
• Parastomal Hernia — all drugs for Parastomal Hernia →
• Colostomy Stoma — all drugs for Colostomy Stoma →

Sponsor

Hospital Donostia

Who can join

Adults 18 to 85, any sex, with Colorectal Neoplasms or Parastomal Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Fascial incision shapes and paracolostomy hernia: cruciate vs. reinforced longitudinal (the "Hepworth hitch"): longcross randomized controlled trial (GECO2 STUDY).
   Elorza G, Carré MK, Pellino G, de Andres Olabarria U, et al · · 2025 · PMID 40629015 · DOI 10.1007/s00384-025-04939-1