Clinical trial NCT05182762: Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries
Official title: Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries: the Clavien-Dindo Classification in a Sri Lankan Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Postoperative Complications
Surgical Complication
Non-communicable Disease
Keywords: Colorectal cancer
Sri Lanka
Clavien-Dindo Classification
Postoperative complications
Surgical quality
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 consecutive patients retrospectively collected from the medical journals at Colombo South Teaching Hospital in Colombo, Sri Lanka.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clavien-Dindo Grade
timeFrame: February 2020 to March 2020
Secondary outcomes:
measure: Age comparison
timeFrame: February 2020 to March 2020
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg, Sahlgrenska Academy
Study officials:
affiliation: Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg..
name: David Ljungman, MD PhD
role: STUDY_DIRECTOR
affiliation: Sahlgrenska Academy, University of Gothenburg.
name: Stina Lindholm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska Academy, University of Gothenburg.
name: Sofia Lindskogen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg.
name: Göran Kurlberg, Asoc prof
role: STUDY_DIRECTOR
affiliation: Dep. of Surgery, Colombo South Teaching Hospital, University of Sri Jayewardenepura.
name: Bawantha Gamage, MD
role: STUDY_DIRECTOR
References: