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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Non-communicable Disease
• Noncommunicable Diseases
• Postoperative Complications
• Surgical Complication

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