Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer

NCT03746353 | Terminated

• 1 other identifier: C190-10300-120
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

Brief Summary

Colorectal cancer worldwide is the third most common in men and the second in female, although mortality is not as high as its incidence, there is less survival in developing countries. According to data from the World Health Organization, in 2012, there were an estimated 1.4 million cases and 693,900 deaths from this disease. Patients with rectal cancer are frequently taken to resection surgery as a curative management of their malignant pathology, according to the type of resection or reconstruction. In a high number of cases, they are management with colorectal anastomosis with a derivative ileostomy in the same procedure. The closure of this ileostomy is usually done after two to three months of the procedure, however in our environment it could take up to six or twelve months, during which time the patient is exposed to social difficulties, management problems and complications, derived from it. The early closure (7-12 days of its creation) of an ileostomy, despite the little evidence, seems to be a safe, feasible procedure that would save the patient having to live temporarily with an ileostomy.

Conditions

Colonic Neoplasms; Ileostomy - Stoma; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• perioperative complications

  To compare the frequency of perioperative complications and quality of life between early ( closure of the derivative ileostomy versus conventional closure in postoperative patients with low anterior resection for rectal cancer. Using the Clavien-Dindo classification (It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life)

  6 yr

Secondary Outcomes (2)

• The follow-up for describe complications

  6 yr

• Measure quality of life

  6 yr

Study Arms (2)

Early closure of ileostomy

EXPERIMENTAL

Early clousure of ileostomy before 30 days

Procedure: early ileostomy closure

Conventional closure of ileostomy

ACTIVE COMPARATOR

Conventional closure of ileostomy after 30 days

Procedure: early ileostomy closure

Interventions

early ileostomy closure PROCEDURE

Assigned interventions Conventional closure of ileostomy: Surgical closure of the protective ileostomy 90 or more days after the proctectomy surgery

Conventional closure of ileostomy; Early closure of ileostomy

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years Diagnosis of Rectal cancer treated at the National Institute of Cancerology and any of the institutions attached to the study

You may not qualify if:

• Complications derived from the anterior resection of the rectum:
• Unresolved intestinal obstruction
• Sepsis
• Organ or space type operative site infection
• Hemodynamic inestability
• Need for reinterventions due to complications
• Coagulopathy
• Active bleeding

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead

Study Sites (3)

Instituto Nacional de Cancerología

Bogota, Cundinamarca, 0000, Colombia

Location

Clinica Vida

Medellín, Colombia

Location

Hospital Pablo Tobón Uribe

Medellín, Colombia

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander Carreño, Md

  Instituto Nacional de Cancerologia, Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: November 19, 2018
• Study Start: September 5, 2018
• Primary Completion: November 11, 2019
• Study Completion: July 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

CO (3)