Textbook Outcome in Colon Carcinoma

NCT ID: NCT05675904

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

564 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Outcome Assessment Cancer of Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Colon oncological resection

Intervention Type PROCEDURE

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

Colon oncological resection

Intervention Type PROCEDURE

Scheduled colon cancer surgery

Interventions

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Colon oncological resection

Scheduled colon cancer surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario de Alicante

OTHER

Sponsor Role lead

Responsible Party

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Candido Fernando Alcazar-Lopez

Principal Investigator, Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital General Universitario Dr. Balmis

Alicante, , Spain

Site Status

Countries

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Spain

Other Identifiers

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12/2022

Identifier Type: -

Identifier Source: org_study_id

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