NCT04397783

Brief 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. 1.Clinically relevant parastomal hernia rate by physical examination 2 years after surgery.
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

May 18, 2020

Last Update Submit

June 14, 2020

Conditions

Colorectal NeoplasmsParastomal HerniaColostomy Stoma

Keywords

end colostomycolostomyparastomal herniahernia preventionprophylaxissurgeryabdominal wall

Outcome Measures

Primary Outcomes (1)

  • parastomal hernia rate by imaging

    parastomal hernia by CT

    2 years

Secondary Outcomes (3)

  • Clinically relevant parastomal hernia rate

    2 years after surgery

  • Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs

    2 years

  • Ease / difficulty in the management of stomatherapy devices

    2 years

Study Arms (2)

Cruciate incision

NO INTERVENTION

the classic cruciate incision in the colostomy construction

longitudinal incision

EXPERIMENTAL

longitudinal incision with two proline sutures

Procedure: construction of an end colostomy

Interventions

construction of an end colostomyPROCEDURE

longitudinal incision in the construction of an end colostomy

Also known as: colorectal surgery
longitudinal incision

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jose Maria Enriquez Navascues

Donostia / San Sebastian, Spain

RECRUITING

Jose Maria Enriquez Navascues

Donostia / San Sebastian, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Garazi Elorza

CONTACT

+34619939947garazielorza@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
computer based aleatoric numbers
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

April 15, 2019

Primary Completion

October 15, 2019

Study Completion

April 15, 2022

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

ES(2)