Cancer of Colon Clinical Trial
Official title:
Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.
NCT number | NCT05675904 |
Other study ID # | 12/2022 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | October 1, 2022 |
Verified date | January 2023 |
Source | Hospital General Universitario de Alicante |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
BACKGROUND: Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer. MATERIAL AND METHODS: Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days. The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.
Status | Completed |
Enrollment | 564 |
Est. completion date | October 1, 2022 |
Est. primary completion date | June 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study Exclusion Criteria: - Age under 18 years - Emergency surgery - Resections of the rectum or resections for pathologies other than cancer - Follow-up of less than two years (with the exception of patients who died) |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Dr. Balmis | Alicante |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario de Alicante |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Textbook Outcome | analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled colon cancer resection | September 2012- August 2016 | |
Primary | Overall survival | relationship between Textbook Outcome and overall survival | From surgery to 160 months | |
Primary | disease-free survival | relationship between Textbook Outcome and disease-free survival | From surgery to 160 months |
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