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

Primary Purpose

Colonic Neoplasms, Ileostomy - Stoma, Colorectal Surgery

Status
Terminated
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
early ileostomy closure
Sponsored by
Instituto Nacional de Cancerologia, Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Cancerología
  • Clinica Vida
  • Hospital Pablo Tobón Uribe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early closure of ileostomy

Conventional closure of ileostomy

Arm Description

Early clousure of ileostomy before 30 days

Conventional closure of ileostomy after 30 days

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Measure quality of life
Using the FACIT-C format (Version 4)

Full Information

First Posted
July 31, 2018
Last Updated
September 1, 2020
Sponsor
Instituto Nacional de Cancerologia, Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03746353
Brief Title
Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer
Official Title
Early Closure of the Derivative Ileostomy Versus Conventional Closure in Postoperative Patients With Low Anterior Resection for Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Cancerologia, Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Ileostomy - Stoma, Colorectal Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early closure of ileostomy
Arm Type
Experimental
Arm Description
Early clousure of ileostomy before 30 days
Arm Title
Conventional closure of ileostomy
Arm Type
Active Comparator
Arm Description
Conventional closure of ileostomy after 30 days
Intervention Type
Procedure
Intervention Name(s)
early ileostomy closure
Intervention Description
Assigned interventions Conventional closure of ileostomy: Surgical closure of the protective ileostomy 90 or more days after the proctectomy surgery
Primary Outcome Measure Information:
Title
perioperative complications
Description
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)
Time Frame
6 yr
Secondary Outcome Measure Information:
Title
The follow-up for describe complications
Description
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)
Time Frame
6 yr
Title
Measure quality of life
Description
Using the FACIT-C format (Version 4)
Time Frame
6 yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Carreño, Md
Organizational Affiliation
Instituto Nacional de Cancerologia, Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Nacional de Cancerología
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Clinica Vida
City
Medellín
Country
Colombia
Facility Name
Hospital Pablo Tobón Uribe
City
Medellín
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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