Clinical trial NCT05284864: Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.
Official title: Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Total Mesorectal Excision
Ileostomy - Stoma
Ileostomy; Complications
Ileostomy Closure
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine and compare morbidity and mortality rates in patients with early and late stoma closure
timeFrame: From rectal surgery to stoma closure surgery
Secondary outcomes:
measure: Determine and analyze quality of life assisted by the SF36 scale in early vs late ileostomy closure
timeFrame: 1 month, 6 month and 1 year after stoma closure surgery
Other outcomes:
measure: Determine the patient's percentage with anterior resection syndrome, after early and late ileostomy closure assisted by the LARS scale.
timeFrame: 1 month, 6 month and 1 year after stoma closure surgery
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario de Coruña
city: Elche
country: Spain
facility: Hospital General de Elche
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Salamanca
country: Spain
facility: Hospital Univesitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari La Fe
Study officials:
References: