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NCT05182762 Clinical Trial

Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries

Colorectal Cancer Clinical Trial

Official title:
Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries: the Clavien-Dindo Classification in a Sri Lankan Cohort

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05182762
Other study ID # MO/PLEC/2020:822
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date December 1, 2021

Study information
Verified date December 2021
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting and to compare the prevalence and severity of complications in patients <60 and ≥60 years of age a retrospective medical records review is used.

Description:

Background: Colorectal cancer (CRC) is increasing in Low- and Middle-Income Countries (LMIC) as part of the ongoing epidemiological transition. Surgery is the main treatment and the global health agenda is increasingly putting focus on improving the safety and quality of surgical care in low-resource settings. The current systems for measuring surgical quality are mainly customized for high-income countries. Aim: To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting. Additionally, to compare the prevalence and severity of complications in patients <60 and ≥60 years of age. Material and methods: Retrospective medical records review for postoperative complications and severity grading using the CDC.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 1, 2021
Est. primary completion date March 17, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who has gone through colorectal cancer resection. - Surgery performed at Colombo South Teaching Hospital in Colombo, Sri Lanka. Exclusion Criteria: - Reason for resection other than colorectal cancer.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden University of Gothenburg, Sahlgrenska Academy Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clavien-Dindo Grade Postoperative complications graded by the Clavien-Dindo Classification. February 2020 to March 2020
Secondary Age comparison Comparison of prevalence and severity of complications between patients <60 and =60 years of age. February 2020 to March 2020
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