NCT05675904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
564

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

December 17, 2022

Last Update Submit

January 5, 2023

Conditions

Outcome AssessmentCancer of Colon

Outcome Measures

Primary Outcomes (3)

  • Textbook Outcome

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

    September 2012- August 2016

  • Overall survival

    relationship between Textbook Outcome and overall survival

    From surgery to 160 months

  • disease-free survival

    relationship between Textbook Outcome and disease-free survival

    From surgery to 160 months

Study Arms (2)

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

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

Interventions

Colon oncological resectionPROCEDURE

Scheduled colon cancer surgery

No Textbook outcomeYes Textbook Outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective colon cancer resection with confirmed histological diagnosis

You may qualify if:

  • Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physician

Study Record Dates

First Submitted

December 17, 2022

First Posted

January 9, 2023

Study Start

January 1, 2022

Primary Completion

June 28, 2022

Study Completion

October 1, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)