NCT05994326

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

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

September 12, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 24, 2023

Last Update Submit

August 15, 2023

Conditions

Colorectal Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mean length of stay

    From admission to date of discharge from hospital, up to 30 days

  • Type of surgery performed

    From admission to date of discharge from hospital, up to 30 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tikur Anbessa Specialized Hospital

Addis Ababa, Ethiopia

Location

Study Officials

  • Åsa Everhov, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Ass professor

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 16, 2023

Study Start

September 12, 2022

Primary Completion

December 11, 2022

Study Completion

December 11, 2022

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)