Colorectal CancerNCT05182762
Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries
An observational study of Colorectal Cancer and Postoperative Complications, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Postoperative Complications, Surgical Complication
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 100 consecutive patients retrospectively collected from the medical journals at Colombo South Teaching Hospital in Colombo, Sri Lanka.
Who may be able to join
- Patients who has gone through colorectal cancer resection.
- Surgery performed at Colombo South Teaching Hospital in Colombo, Sri Lanka.
Who cannot join
- Reason for resection other than colorectal cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries: the Clavien-Dindo Classification in a Sri Lankan Cohort
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.
Read the 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.
- Conditions
- Colorectal Cancer, Postoperative Complications, Surgical Complication, Non-communicable Disease
- Keywords
- Colorectal cancer, Sri Lanka, Clavien-Dindo Classification, Postoperative complications, Surgical quality
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications, Noncommunicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Clavien-Dindo Grade
Postoperative complications graded by the Clavien-Dindo Classification.
Measured: February 2020 to March 2020
Secondary outcomes (1)
Age comparison
Comparison of prevalence and severity of complications between patients <60 and ≥60 years of age.
Measured: February 2020 to March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Feb 2020
- Primary completion17 Mar 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ljungman, Sahlgrenska University Hospital
- Investigators
- David Ljungman, MD PhD, Study director, Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg..Stina Lindholm, MD, Principal investigator, Sahlgrenska Academy, University of Gothenburg.Sofia Lindskogen, MD, Principal investigator, Sahlgrenska Academy, University of Gothenburg.Göran Kurlberg, Asoc prof, Study director, Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg.Bawantha Gamage, MD, Study director, Dep. of Surgery, Colombo South Teaching Hospital, University of Sri Jayewardenepura.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182762
- Sponsor's protocol ID
- MO/PLEC/2020:822
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries: the Clavien-Dindo Classification in a Sri Lankan Cohort
- ClinicalTrials.gov ID
- NCT05182762
- Acronym / sponsor ID
- MO/PLEC/2020:822
- Conditions
- Colorectal Cancer, Postoperative Complications, Surgical Complication, Non-communicable Disease
- Keywords
- Colorectal cancer, Sri Lanka, Clavien-Dindo Classification, Postoperative complications, Surgical quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 consecutive patients retrospectively collected from the medical journals at Colombo South Teaching Hospital in Colombo, Sri Lanka.
Key inclusion criteria (2 listed)
- Patients who has gone through colorectal cancer resection.
- Surgery performed at Colombo South Teaching Hospital in Colombo, Sri Lanka.
Key exclusion criteria (1 listed)
- Reason for resection other than colorectal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clavien-Dindo Grade
Time frame: February 2020 to March 2020
Postoperative complications graded by the Clavien-Dindo Classification.
1 secondary outcome
Age comparison
Time frame: February 2020 to March 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ljungman, MD PhD study director
Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg..
Stina Lindholm, MD principal investigator
Sahlgrenska Academy, University of Gothenburg.
Sofia Lindskogen, MD principal investigator
Sahlgrenska Academy, University of Gothenburg.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Postoperative Complications, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clavien-Dindo Grade (time frame: February 2020 to March 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.