NCT05182762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
Last Updated

January 10, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 8, 2021

Last Update Submit

December 21, 2021

Conditions

Colorectal CancerPostoperative ComplicationsSurgical ComplicationNon-communicable Disease

Keywords

Colorectal cancerSri LankaClavien-Dindo ClassificationPostoperative complicationsSurgical quality

Outcome Measures

Primary Outcomes (1)

  • Clavien-Dindo Grade

    Postoperative complications graded by the Clavien-Dindo Classification.

    February 2020 to March 2020

Secondary Outcomes (1)

  • Age comparison

    February 2020 to March 2020

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 consecutive patients retrospectively collected from the medical journals at Colombo South Teaching Hospital in Colombo, Sri Lanka.

You may qualify if:

  • Patients who has gone through colorectal cancer resection.
  • Surgery performed at Colombo South Teaching Hospital in Colombo, Sri Lanka.

You may not qualify if:

  • Reason for resection other than colorectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg, Sahlgrenska Academy

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPostoperative ComplicationsNoncommunicable Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • David Ljungman, MD PhD

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

    STUDY DIRECTOR

  • Stina Lindholm, MD

    Sahlgrenska Academy, University of Gothenburg.

    PRINCIPAL INVESTIGATOR

  • Sofia Lindskogen, MD

    Sahlgrenska Academy, University of Gothenburg.

    PRINCIPAL INVESTIGATOR

  • 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.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant surgeon

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 10, 2022

Study Start

February 1, 2020

Primary Completion

March 17, 2020

Study Completion

December 1, 2021

Last Updated

January 10, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)