Colonic Neoplasms Clinical Trial
Official title:
Early Closure of the Derivative Ileostomy Versus Conventional Closure in Postoperative Patients With Low Anterior Resection for Rectal Cancer
Verified date | September 2020 |
Source | Instituto Nacional de Cancerologia, Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 52 |
Est. completion date | July 1, 2020 |
Est. primary completion date | November 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Colombia | Instituto Nacional de Cancerología | Bogota | Cundinamarca |
Colombia | Clinica Vida | Medellín | |
Colombia | Hospital Pablo Tobón Uribe | Medellín |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancerologia, Columbia |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Measure quality of life | Using the FACIT-C format (Version 4) | 6 yr |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05809999 -
IBD Neoplasia Surveillance RCT
|
N/A | |
Recruiting |
NCT06041945 -
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
|
N/A | |
Not yet recruiting |
NCT02688699 -
Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
|
Phase 4 | |
Not yet recruiting |
NCT03175146 -
A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
|
N/A | |
Completed |
NCT02529007 -
Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
|
N/A | |
Not yet recruiting |
NCT01929499 -
Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
|
Phase 2 | |
Completed |
NCT01681472 -
PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01438645 -
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
|
N/A | |
Completed |
NCT00535652 -
Concentration of Ertapenem in Colorectal Tissue
|
Phase 4 | |
Terminated |
NCT00267787 -
Molecular Genetic and Pathological Studies of Anal Tumors
|
||
Completed |
NCT05498051 -
Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Submucosal Bevacizumab-800CW.
|
N/A | |
Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
Recruiting |
NCT03314896 -
Laparoscopic Surgery for T4 Tumor of the Colon Cancer (LST4C Trial)
|
N/A | |
Not yet recruiting |
NCT02852915 -
Laparoscopic Surgery for T4 Tumor of the Colon Cancer
|
Phase 3 | |
Not yet recruiting |
NCT02777437 -
Laparoscopic Surgery VS Laparoscopic Surgery + Neoadjuvant Chemotherapy for T4 Tumor of the Colon Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT00997802 -
Japanese National Computed Tomographic (CT) Colonography Trial
|
N/A | |
Completed |
NCT01056913 -
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
|
Phase 4 | |
Completed |
NCT00537901 -
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study
|
N/A | |
Completed |
NCT00470782 -
Aerobic Capacity and Body Composition in Colon Cancer Patients
|
N/A | |
Completed |
NCT00275210 -
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
|
Phase 3 |