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

Early Closure of the Derivative Ileostomy Versus Conventional Closure in Postoperative Patients With Low Anterior Resection for Rectal Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Surgery; Colonic Neoplasms; Ileostomy - Stoma
• Intervention / Treatment: Procedure: early ileostomy closure

Detailed Description

General purpose:

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.

Materials and methods:

Controlled clinical trial, randomized, to be carried out at the National Cancer Institute of Colombia E.S.E. Eligible candidates for the study will be patients older than 18 years who have undergone a previous resection of the rectum plus a derivative ileostomy for colorectal cancer. All patients eligible for inclusion will undergo computed axial tomography with rectal contrast medium on postoperative day 5. Those who meet the inclusion criteria and do not present any of the exclusion criteria will enter the study, prior willingness to participate by part of the patient and obtaining verbal and written informed consent. Through computer-generated randomization, patients will undergo early closure (between 7 and 12 days after the ileostomy) versus conventional closure (after 90 days or more time from the creation of the ileostomy). A sample size of 81 patients was calculated for each arm. The follow-up will be done in both groups at 3, 6, 9 and 12 months after the creation of the ileostomy, including complications using the Clavien-Dindo classification and quality of life using the FACIT-C format. The statistical analysis will be done by protocol and intention to treat. The perioperative complications associated with the closure of the ileostomy, the complications associated with the presence of ileostomy, hospital stay, and quality of life will be analyzed.

Expected impact:

The investigators hope to find that the early closure of ileostomy in patients during the immediate postoperative period of previous resection due to rectal cancer is safe in terms of morbidity and mortality, feasible and with benefits in quality of life during the immediate postoperative period compared with patients to whom they are closed late (after 3 months).

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Medellín, Colombia
    • Hospital Pablo Tobón Uribe
  • Medellín, Colombia
    • Clinica Vida
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 0000
      • Instituto Nacional de Cancerologia

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

Exclusion criteria:

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

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 closure of ileostomy; Early clousure of ileostomy before 30 days	Procedure: early ileostomy closure; Assigned interventions Conventional closure of ileostomy: Surgical closure of the protective ileostomy 90 or more days after the proctectomy surgery
Active Comparator: Conventional closure of ileostomy; Conventional closure of ileostomy after 30 days	Procedure: early ileostomy closure; Assigned interventions Conventional closure of ileostomy: Surgical closure of the protective ileostomy 90 or more days after the proctectomy surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The follow-up for describe complications	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
Measure quality of life	Using the FACIT-C format (Version 4)	6 yr

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cancerologia, Columbia
• Investigators: Study Director: Alexander Carreño, Md, Instituto Nacional de Cancerologia, Columbia

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

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; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: C190-10300-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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