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 |
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