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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-01

Brief Summary

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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).

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Detailed Description

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Total mesorectal excision (TME) is considered the gold standard in obtaining a negative circumferential resection margin for cancers of the middle and lower third of the rectum. Despite all the oncological benefits,TME in ultra-low anterior resection carries some important drawbacks, such as a longer operative time, and its association with a higher rate of anastomotic leakage which increases in the most distal anastomoses.

Among the measures adopted to reduce mortality, the creation of protective ostomies has proven to be effective, however the protective ileostomy and its closure are not free of complications, such as dehydration and chronic kidney failure. In the investigator's country, various studies have analyzed this time to closure, being 10.8 months on average and with an increase in morbidity when closure is delayed the longest.

There are few prospective studies on the timing of stoma closure, which mainly focused on morbidity and mortality related to early closure. These studies did not demonstrate any significant negative effects on morbidity or mortality. The reason for early closure of the stoma is to reduce complications related to it. Although its true incidence is unknown, most patients have some type of stoma-related complication, which can be avoided or decreased in the case of early closure. In addition to the complications on the patient and their quality of life, the hospital costs secondary to them are not negligible.

The TIMES study ("TIMing Evaluation of Stoma closure") arises from the need to know the ideal moment for the closure of derivative stomata after rectal surgery.

Therefore, the hypothesis is that patients who undergo early ileostomy closure (at 2-3 weeks) after ultra-low anterior resection have fewer complications than patients with late ileostomy closure (4-6 months).

The main objective of this study is to analyze the morbidity and mortality associated with both early (early group, CASES group) and late closure (late group, CONTROL group) of the derivative ileosomy.

In this study, patients scheduled for temporary stoma closure after scheduled colorectal surgery will be randomized into two groups: early closure (14-21 days after surgery) or late closure (4th-6th month after surgery).

Patients will be followed from the time of study entry until 12 months after stoma closure.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early stoma closure

Stoma closure 2-3 weeks after rectal surgery.

Group Type EXPERIMENTAL

Stoma closure

Intervention Type PROCEDURE

Stoma closure after rectal surgery

Late stoma closure

Stoma closure 16-24 weeks after rectal surgery.

Group Type ACTIVE_COMPARATOR

Stoma closure

Intervention Type PROCEDURE

Stoma closure after rectal surgery

Interventions

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Stoma closure

Stoma closure after rectal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Blas Flor Lorente

General Surgery and Digestive System Service. Coloproctology Unit. Hospital Universitario y Politécnico La Fe. Principal Investigator, Associate Professor of Surgery. University of Valencia.

Responsibility Role PRINCIPAL_INVESTIGATOR