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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2023
Source Hospital General Universitario de Alicante
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Colon oncological resection
Scheduled colon cancer surgery

Locations

Country Name City State
Spain Hospital General Universitario Dr. Balmis Alicante

Sponsors (1)

Lead Sponsor Collaborator
Hospital General Universitario de Alicante

Country where clinical trial is conducted

Spain, 

Outcome

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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