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NCT05994326 Clinical Trial

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

Colorectal Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05994326
Other study ID # Dnr: 2019-03867
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 12, 2022
Est. completion date December 11, 2022

Study information
Verified date August 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date December 11, 2022
Est. primary completion date December 11, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Ethiopia Tikur Anbessa Specialized Hospital Addis Ababa

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Ethiopia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion postoperative complications 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 Mean length of stay Mean number of days in hospital From admission to date of discharge from hospital, up to 30 days
Secondary Type of surgery performed 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
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