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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05284864
Other study ID # TIMES
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 1, 2024

Study information

Verified date March 2022
Source Hospital Universitario La Fe
Contact David Abelló
Phone +34630306333
Email davidabello1@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Stoma closure
Stoma closure after rectal surgery

Locations

Country Name City State
Spain Hospital General Universitario de Alicante Alicante
Spain Complejo Hospitalario Universitario de Coruña Coruña
Spain Hospital General de Elche Elche
Spain Hospital Josep Trueta Girona
Spain Hospital Gregorio Marañón Madrid
Spain Hospital Ramón y Cajal Madrid
Spain Complejo Hospitalario de Pontevedra Pontevedra
Spain Hospital Univesitario de Salamanca Salamanca
Spain Hospital Universitari La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Determine the patient's percentage with anterior resection syndrome, after early and late ileostomy closure assisted by the LARS scale. The LARS score has been validated and translated into several languages. By applying binomial regression on patient responses, the five issues that most bothered the patients were selected: incontinence for flatus, incontinence for liquid stool, frequency, clustering and urgency. Rating scale ranges from 0 to 42 points, and patients are classified into three groups: "no LARS" (0-20 points), "minor LARS" (21-29 points) and "major LARS" (30-42 points). According to the authors, the LARS score facilitates a fast identification of patients categorized as major LARS who will require treatment 1 month, 6 month and 1 year after stoma closure surgery
Primary Determine and compare morbidity and mortality rates in patients with early and late stoma closure From rectal surgery to stoma closure surgery
Secondary Determine and analyze quality of life assisted by the SF36 scale in early vs late ileostomy closure The SF36 is a short questionnaire with 36 items which measure eight multi-item variables: physical functioning (10 items), social functioning (two items), role limitations due to physical problems (four items), role limitations due to emotional problems (three items), mental health (five items), energy and vitality (four items), pain (two items), and general perception of health (five items). There is a further unscaled single item on changes in respondents' health over the past year. For each variable item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state). 1 month, 6 month and 1 year after stoma closure surgery
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