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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT05994326
Collaborator
(none)
47
Enrollment
1
Location
3
Actual Duration (Months)
15.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    47 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Perioperative Care and Short-term Outcomes of Colorectal Surgery: A Prospective Study From Tikur Anbessa Specialized Hospital in Addis Abeba Ethiopia
    Actual Study Start Date :
    Sep 12, 2022
    Actual Primary Completion Date :
    Dec 11, 2022
    Actual Study Completion Date :
    Dec 11, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Proportion postoperative complications [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

    Secondary Outcome Measures

    1. Mean length of stay [From admission to date of discharge from hospital, up to 30 days]

      Mean number of days in hospital

    2. Type of surgery performed [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tikur Anbessa Specialized Hospital Addis Ababa Ethiopia

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Åsa Hallqvist Everhov, Principal investigator, Ass professor, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT05994326
    Other Study ID Numbers:
    • Dnr: 2019-03867
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 16, 2023