Perioperative Care and Short-term Outcomes of Colorectal Surgery in Addis Abeba

August 15, 2023 updated by: Åsa Hallqvist Everhov, Karolinska Institutet

Perioperative Care and Short-term Outcomes of Colorectal Surgery: A Prospective Study From Tikur Anbessa Specialized Hospital in Addis Abeba Ethiopia

Observational cohort study of adult patients undergoing colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months.

Study Overview

Status

Completed

Conditions

Detailed Description

Observational prospective cohort study, including all adult (≥18) patients undergoing colorectal surgery at Tikur Anbessa Specialized Hospital in Addis Abeba for 3 months. Variables are patients' characteristics, risk factors, investigations, types of operations, level of training of surgeon, and postoperative management. The data collection is conducted at admission, day of surgery, and discharge. The primary outcomes are in-hospital complications and length of stay, and the secondary outcomes are perioperative management.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia
        • Tikur Anbessa Specialized Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years) with willingness and ability to give informed consent, who were admitted to the surgical department at TASH (elective or in an emergency) and operated for a colorectal condition

Description

Inclusion Criteria:

  • Age ≥18 years
  • Willingness and ability to give informed consent
  • Admitted to the surgical department at TASH (elective or in an emergency) and operated for a colorectal condition

Exclusion Criteria:

-Emergency conditions usually managed in general surgery, e.g., perianal conditions and adhesive small bowel obstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion postoperative complications
Time Frame: From date of surgery to date of discharge from hospital or maximun 30 days postoperatively
Number and proportion (%) of patients with any postoperative complication according to Clavien-Dindo
From date of surgery to date of discharge from hospital or maximun 30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean length of stay
Time Frame: From admission to date of discharge from hospital, up to 30 days
Mean number of days in hospital
From admission to date of discharge from hospital, up to 30 days
Type of surgery performed
Time Frame: From admission to date of discharge from hospital, up to 30 days
Number and proportion (%) of colorectal operations performed (colectomy, rectal resection, stoma without resection)
From admission to date of discharge from hospital, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Åsa Everhov, MD PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

December 11, 2022

Study Completion (Actual)

December 11, 2022

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Dnr: 2019-03867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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