Building Capacity for Screening & Early Diagnosis of Colorectal Cancer Through a Comprehensive Colonoscopy Training Program in Nigeria

NCT05686499 | Recruiting DMC

• 1 other identifier: ERC/2022/07/03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This protocol seeks to develop a colonoscopy training program in Nigeria in order to increase the number of health care providers proficient in colonoscopy. The goal is to improve capacity for screening and early diagnosis of colorectal cancer (CRC) by training and expanding the healthcare workforce that is competent in endoscopy techniques. The project has three components, a needs assessment, simulation training, and training on live patients. The first part of this project determines the number of providers and endoscopy procedures currently performed in Nigeria, as well as patient access to facilities that have colonoscopy capabilities, through a mixed methods approach. Surveys, focus in-depth interviews with key stakeholders, and use geographic information system (GIS) modeling technology will be employed to perform a needs assessment. The second component of this project investigates whether a locally developed low fidelity (LF) simulation colonoscopy training model is an effective teaching, training, and assessment tool for skill acquisition and confidence compared to a high-fidelity (HF) colonoscopy model. The third component of this project is training healthcare providers on real patients who have an indication for colonoscopy. This project seeks to build capacity for endoscopy services in order to increase capacity for screening and early diagnosis of CRC. At the end of the project, it is expected the number of providers trained to perform colonoscopy in a resource limited setting like Nigeria will increase.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• ratio of low-fidelity simulator trained endoscopists with improved colonoscopy performance on real patients to high-fidelity simulator trained endoscopists with improved performance on real patients

  proportion of LF simulator training who can perform colonoscopy adequately on live patient to proportion of HF simulator training who can perform colonoscopy adequately on live patients

  5 days

Study Arms (2)

High Fidelity (HF) Arm

ACTIVE COMPARATOR

The HF simulator will be Limbs and Things Colonoscopy Training Model product KKM40.

Other: Didactic Lectures and demonstrations

Low Fidelity (LF) Arm

EXPERIMENTAL

The LF simulator will be made in Nigeria, based on low fidelity models that have been published in the literature

Other: Didactic Lectures and demonstrations

Interventions

Didactic Lectures and demonstrations OTHER

1. Trainees will receive 4-6 hours of didactic colonscopy lecture sessions based on the American Board of Surgery Flexible Endoscopy curriculum for general surgery residents, general surgery resident curriculum (SCORE) endoscopy module, and the Joint Advisory group on GI Endoscopy program adapted to Nigeria context. 2. Trainees will have the opportunity to practice colonoscopy on HF or LF simulators (depending on the arm) with immediate feedback from instructors.

High Fidelity (HF) Arm; Low Fidelity (LF) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Health care professionals will include consultants and registrars in medicine, surgery, and gastroenterology

You may not qualify if:

• Participants under the age of 18
• Participants unwilling to sign consent

Sponsors & Collaborators

• Obafemi Awolowo University Teaching Hospital: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (2)

Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals

Ile-Ife, Osun State, 220005, Nigeria

RECRUITING

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, 220005, Nigeria

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Trainees will be selected from among resident doctors and consultants working in teaching hospitals and federal medical centres that have facilities for colonoscopy. These will be randomized into two arms - high fidelity (HF) and low fidelity (LF) arms. Baseline test will then be carried out by the trainees after which they will be exposed to colonoscopy lectures and demonstrations using respective fidelity type to which they are randomized. Simulation examination will then be carried out after which trainees will be cross-overed to alternate arms for further simulation on different fidelity types. They will then all have opportunity to perform colonoscopy on live patients which will be supervised and accessed by trainers.

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: January 17, 2023
• Study Start: March 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available within three months of study commencement and it will be hosted on the redcap for 10years
• Access Criteria: Being a research staff (principal investigator, co-investigators, programme / clinical research managers, clinical research coordinators, research assistants) working in the two collaborative sites

Locations

NG (2)