Textbook Outcome in Colon Carcinoma

• Sponsor: Hospital General Universitario de Alicante (Other)
• Overall Status: Completed
• CT.gov ID: NCT05675904
• Collaborator: (none)
• Enrollment: 564
• Location: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 62.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Outcome Assessment; Cancer of Colon	Procedure: Colon oncological resection

Study Design

• Study Type: Observational
• Actual Enrollment: 564 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Textbook Outcome in Colon Carcinoma: Implications for Overall Survival and Disease-free Survival.
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Jun 28, 2022
• Actual Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Yes Textbook Outcome Patients undergoing scheduled colon cancer surgery with a 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	Procedure: Colon oncological resection; Scheduled colon cancer surgery
No Textbook outcome Patients undergoing scheduled colon cancer surgery without any of the following items: 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	Procedure: Colon oncological resection; Scheduled colon cancer surgery

Outcome Measures

Primary Outcome Measures

1. Textbook Outcome [September 2012- August 2016]

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

2. Overall survival [From surgery to 160 months]

   relationship between Textbook Outcome and overall survival

3. disease-free survival [From surgery to 160 months]

   relationship between Textbook Outcome and disease-free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General Universitario Dr. Balmis	Alicante		Spain	03010

Sponsors and Collaborators

• Hospital General Universitario de Alicante

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Candido Fernando Alcazar-Lopez, Principal Investigator, Physician, Hospital General Universitario de Alicante
• ClinicalTrials.gov Identifier: NCT05675904
• Other Study ID Numbers: 12/2022
• First Posted: Jan 9, 2023
• Last Update Posted: Jan 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Jan 9, 2023