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

NCT ID: NCT05182762

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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

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Colorectal Cancer Postoperative Complications Surgical Complication Non-communicable Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Ljungman

Consultant surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ljungman, MD PhD

Role: STUDY_DIRECTOR

Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg..

Stina Lindholm, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Academy, University of Gothenburg.

Sofia Lindskogen, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Academy, University of Gothenburg.

Göran Kurlberg, Asoc prof

Role: STUDY_DIRECTOR

Dep. of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg.

Bawantha Gamage, MD

Role: STUDY_DIRECTOR

Dep. of Surgery, Colombo South Teaching Hospital, University of Sri Jayewardenepura.

Locations

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University of Gothenburg, Sahlgrenska Academy

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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MO/PLEC/2020:822

Identifier Type: -

Identifier Source: org_study_id

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