Textbook Outcome in Colon Carcinoma

Cancer of Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675904
• Other study ID #: 12/2022
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Cancer of Colon
• Colonic Neoplasms
• Outcome Assessment

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