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

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT05182762

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Postoperative Complications Surgical Complication Non-communicable Disease

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Mar 17, 2020

Actual Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

Clavien-Dindo Grade [February 2020 to March 2020]
Postoperative complications graded by the Clavien-Dindo Classification.

Secondary Outcome Measures

Age comparison [February 2020 to March 2020]
Comparison of prevalence and severity of complications between patients <60 and ≥60 years of age.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Gothenburg, Sahlgrenska Academy	Gothenburg		Sweden

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

Study Director: David Ljungman, MD PhD, Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg..
Principal Investigator: Stina Lindholm, MD, Sahlgrenska Academy, University of Gothenburg.
Principal Investigator: Sofia Lindskogen, MD, Sahlgrenska Academy, University of Gothenburg.
Study Director: Göran Kurlberg, Asoc prof, Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg.
Study Director: Bawantha Gamage, MD, Dep. of Surgery, Colombo South Teaching Hospital, University of Sri Jayewardenepura.