Textbook Outcome in Colon Carcinoma

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.

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Key information

Conditions

Outcome Assessment Cancer of Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Colon oncological resection

Procedure

Scheduled colon cancer surgery

Primary outcomes

Textbook Outcome

Time frame: September 2012- August 2016

analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled colon cancer resection
Overall survival

Time frame: From surgery to 160 months

relationship between Textbook Outcome and overall survival
disease-free survival

Time frame: From surgery to 160 months

relationship between Textbook Outcome and disease-free survival

Sponsors and collaborators

Lead sponsor

Hospital General Universitario de Alicante

Other

Registry information

Official study title

Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jan 9, 2023
Registry last updated: Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed