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

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).

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Ileostomy; Complications; Ileostomy - Stoma; Total Mesorectal Excision; Ileostomy Closure
• Intervention / Treatment: Procedure: Stoma closure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Abelló; Phone Number: 412370 +34630306333; Email: davidabello1@gmail.com

Study Locations

• Spain
  • Alicante, Spain
    • Recruiting
    • Hospital General Universitario de Alicante
  • Coruña, Spain
    • Recruiting
    • Complejo Hospitalario Universitario de Coruña
  • Elche, Spain
    • Recruiting
    • Hospital General de Elche
  • Girona, Spain
    • Recruiting
    • Hospital Josep Trueta
  • Madrid, Spain
    • Recruiting
    • Hospital Gregorio Marañón
  • Madrid, Spain
    • Recruiting
    • Hospital Ramon y Cajal
  • Pontevedra, Spain
    • Recruiting
    • Complejo Hospitalario de Pontevedra
  • Salamanca, Spain
    • Recruiting
    • Hospital Univesitario de Salamanca
  • Valencia, Spain
    • Recruiting
    • Hospital Universitari La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early stoma closure; Stoma closure 2-3 weeks after rectal surgery.	Procedure: Stoma closure; Stoma closure after rectal surgery
Active Comparator: Late stoma closure; Stoma closure 16-24 weeks after rectal surgery.	Procedure: Stoma closure; Stoma closure after rectal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine and compare morbidity and mortality rates in patients with early and late stoma closure	From rectal surgery to stoma closure surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: TIMES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No