Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries: the Clavien-Dindo Classification in a Sri Lankan Cohort
Conditions: Colorectal Cancer, Postoperative Complications, Surgical Complication, Non-communicable Disease
Sponsor: Sahlgrenska University Hospital

December 1, 2021 
 
 
Measuring quality in colorectal cancer surgery in Low- and Middle-
Income Countries: The Clavien-Dindo Classification in a Sri Lankan 
cohort 
 
S. Lindholma, S. Lindskogena, B. Gamageb, G. Kurlbergc, D. Ljungmanc,d*  
a Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden 
b Department of Surgery, Colombo South Teaching Hospital, University of Sri 
Jayewardenepura, Nugegoda, Sri Lanka 
c Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of 
Gothenburg, Gothenburg, Sweden 
d Region Västra Götaland, Department of Surgery, Sahlgrenska University Hospital, 
Gothenburg, Sweden 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

December 1, 2021 
 
 
STUDY SUMMARY 
 
Title 
Measuring quality in colorectal cancer surgery in Low- and Middle-
Income Countries: The Clavien-Dindo Classification in a Sri Lankan 
cohort. 
Methodology 
Retrospective, medical record study, cohort 
Study Duration Data collection from February to March 2020.  
Study 
Center(s) 
Single center (Colombo South Teaching Hospital, CSTH, Sri Lanka). 
Objectives 
Primary Objective: To test the applicability of the Clavien-Dindo 
Classification in a Low- and Middle-Income Country.  
 
Secondary Objectives: To compare the prevalence and severity of 
complications between patients <60 and ≥60 years of age. To determine 
length of hospital stay (LOS). 
 
Number of 
subjects 
88 patients. 
Diagnosis and 
Main Inclusion 
Criteria 
Inclusion criteria: 
- Male and female patients in any age 
- Patients who undergone colorectal cancer resection 
- Operation performed at Colombo South Teaching Hospital 
- Surgery performed at any date 
 
Exclusion criteria: 
- Reason for resection other than colorectal cancer. 
 
Study Product, 
Dose, Route, 
Regimen 
No intervention. 
Statistical 
Methodology 
Primary Endpoint: Clavien-Dindo Classification calculated with 
descriptive analyzes. 
 
Secondary Endpoints: Chi-squared test. 
 
 
Purpose:  
The aim of this study is to investigate short-term outcome after colorectal cancer surgery in a 
Sri Lankan facility using the Clavien-Dindo Classification to evaluate it as an applicable 
instrument for measuring surgical quality at medical institutions in Low- and Middle-Income 
Countries. 
 
Background: 
Colorectal cancer is increasing in Low- and Middle-Income Countries as a part of the on-
going epidemiological transition. Surgery is the main treatment and global health is now 
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. 
 
 

December 1, 2021 
 
 
Goals of the study: 
1. To investigate short-term outcome after colorectal cancer surgery in a Sri Lankan facility 
using the Clavien-Dindo Classification to evaluate it as an applicable instrument for 
measuring surgical quality at medical institutions in Low- and Middle-Income Countries. 
2. To determine length of hospital stay (LOS) as an indicator of process quality. 
3. To compare prevalence and severity of overall complications between patients <60 and ≥60 
years of age. 
 
Duration of the Study: 
Data collection February to March 2020. Statistical analyzes April to May 2020. 
 
Potential Benefits and Risks to Patients: 
There is no benefits or risks for the patients since the study is retrospective and based on 
medical records. 
 
Methods: 
- Study Design 
This is a retrospective single centre cohort study based on medical records of patients who 
have undergone resection for colorectal cancer at Colombo South Teaching Hospital (CSTH) 
from 2017 to the time for data collection. STROCSS guidelines will be used in the reporting 
of the research. The medical records will be reviewed retrospectively for postoperative 
complications and the severity will be graded using the Clavien-Dindo Classification. 
 
- Study population and selection criteria 
No consent forms are needed since the study is retrospective and based on medical records. 
Patients included in the study will have undergone colorectal cancer resection at Colombo 
South Teaching Hospital. Both male and female patients in any age will be included. Patients 
will be excluded from the study if reason for resection is other than colorectal cancer.  
 
- Recruitment methods 
Patients will be collected from the medical records at the surgical department at Colombo 
South Teaching Hospital.  
 
- Data collection and reporting 
Demographic, clinical and pathological characteristics of patients and details of surgeries and 
postoperative outcome will be obtained from the medical records and documented in Excel. 
Length of hospital stay (LOS) will be calculated. The medical record will be reviewed for 
postoperative complications and the treatment required. The severity of complications will be 
graded according to the Clavien-Dindo Classification. Patients will be anonymized using 
unique study identification numbers. 
 
Participant Withdrawal or Termination: 
None since it is a retrospective study based on medical records. 
 
RANDOMIZATION 
None, since no intervention is planned. 
 
STATISTICAL ANALYSIS PLAN 
- Primary Endpoint: Distribution of the Clavien-Dindo Classification will be determined by 
using descriptive analyzes in Statistical Package for the Social Sciences (SPSS) version 26. 

December 1, 2021 
 
 
- Secondary Endpoints: To test if there is any difference in the prevalence and severity of 
complications between patients <60 and ≥60 years of age  the Chi-squared test will be used. 
P<0.05 is considered statistically significant. 
 
ASSESSMENT OF SAFETY 
No risk of adverse events since the study is retrospective and based on medical records. 
 
DATA MONITORING 
The Principal Investigators will be responsible to ensure that the study is conducted in 
accordance with the protocol. Also, that the reported data are accurate, complete and valid.  
 
DATA HANDLING AND RECORD KEEPING 
Only the Principal Investigators will handle personal patient information and no unneeded 
sensitive information is being collected. The data will be kept in a personal computer locked 
in. All data will be anonymized using unique study identification numbers in an Excel file, 
which will be used for the rest of the study time. 
 
INSTITUTIONAL REVIEW BOARD 
Ethical approval was received from the Ethics Review Committee of the Colombo South 
Teaching Hospital, January 13th 2020 (reference number MO/PLEC/2020:822). 
 
CONSENT PROCESS 
No informed consent form is needed since this is a retrospective, medical record study. 
 
 
LAWS AND REGULATIONS 
This study will align to the principles of the Helsinki Declaration. It will be reported 
according to the STROCSS guidelines. No national laws or regulations will be crossed. The 
trial will be registered on www.clintrials.gov. 
 
PUBLICATION AND DATA SHARING POLICY 
Data is owned by the participating institutions. Manuscript is written by participating 
institutions, data sharing upon reasonable request. 
 
 
STUDY PERSONNEL AND ROLES 
 
Stina Lindholm, MD 
Principal Investigator 
Conceptualization, 
methodology, formal 
analysis, investigation, 
writing, project 
administration.  
Sofia Lindskogen, MD 
Principal Investigator 
Conceptualization, 
methodology, investigation, 
visualization, writing, 
project administration. 
David Ljungmang, MD 
PhD 
Co-Investigator, Project Manager 
Supervision, validation, 
writing (review & editing). 
Göran Kurlberg, Assoc 
Prof 
Co-Investigator, Project Manager 
Supervision, validation, 
writing (review & editing). 

December 1, 2021 
 
 
Bawantha Gamage, MD Project Manager 
Supervision, validation, 
writing (review & editing). 
 
 
CONFLICTS OF INTEREST 
No conflicts of interest have been reported.