Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.

NCT05284864 | Unknown

• 1 other identifier: TIMES
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to asses the safety and efficacy of early stoma closure (2-3 weeks after total mesorectal excision) vs late closure (16-24 weeks after mesorectal excision).

Conditions

Rectal Cancer; Total Mesorectal Excision; Ileostomy - Stoma; Ileostomy; Complications; Ileostomy Closure

Outcome Measures

Primary Outcomes (1)

• Determine and compare morbidity and mortality rates in patients with early and late stoma closure

  From rectal surgery to stoma closure surgery

Secondary Outcomes (1)

• Determine and analyze quality of life assisted by the SF36 scale in early vs late ileostomy closure

  1 month, 6 month and 1 year after stoma closure surgery

Other Outcomes (1)

• Determine the patient's percentage with anterior resection syndrome, after early and late ileostomy closure assisted by the LARS scale.

  1 month, 6 month and 1 year after stoma closure surgery

Study Arms (2)

Early stoma closure

EXPERIMENTAL

Stoma closure 2-3 weeks after rectal surgery.

Procedure: Stoma closure

Late stoma closure

ACTIVE COMPARATOR

Stoma closure 16-24 weeks after rectal surgery.

Procedure: Stoma closure

Interventions

Stoma closure PROCEDURE

Stoma closure after rectal surgery

Early stoma closure; Late stoma closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with rectal cancer (with / without metastasis) (with / without chemoterapy or radiotherapy)
• Patients undergoing low or ultra low anterior resection with anastomosis and stoma of protection.
• Patients with no intraoperative or postoperative complications.
• Radiological confirmation of the absence of anastomotic compilations (opaque enema or abdominal-pelvic CT scan with rectal contrast)
• Confirmation by rectoscopy of the absence of anastomotic compilations

You may not qualify if:

• Rectal cancer surgeries without anastomosis.
• Rectal cancer surgeries without stoma of protection.

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (9)

Complejo Hospitalario Universitario de Coruña

A Coruña, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Spain

RECRUITING

Hospital General de Elche

Elche, Spain

RECRUITING

Hospital Josep Trueta

Girona, Spain

RECRUITING

Hospital Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, Spain

RECRUITING

Complejo Hospitalario de Pontevedra

Pontevedra, Spain

RECRUITING

Hospital Univesitario de Salamanca

Salamanca, Spain

RECRUITING

Hospital Universitari La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

David Abelló

CONTACT

+34630306333; davidabello1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery and Digestive System Service. Coloproctology Unit. Hospital Universitario y Politécnico La Fe. Principal Investigator, Associate Professor of Surgery. University of Valencia.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: March 17, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)