Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202502863551536 Date of Registration: 03/02/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessing the effectiveness of implementing ERAS protocols on hospital length of stay and patient outcomes in Bellwether surgical procedures in Ethiopia: Randomized Pragmatic Cluster Trial
Official scientific title Optimizing Surgical Care in Ethiopia: Assessing ERAS Implementation, Evaluating Outcomes, and Examining Economic Impact
Brief summary describing the background and objectives of the trial Background Access to surgical care in Ethiopia remains inadequate and disproportionately unequal. The number of surgeries performed in Ethiopia's public health facilities falls significantly short of the target of 5000 surgeries per 100,000 population per year, which is intended to be achieved by 2030. Although research is limited, a systematic review and meta-analysis of gastrointestinal surgery have shown that Enhanced Recovery After Surgery (ERAS) practices in African settings offer similar benefits to those in high-income countries. These benefits include shorter hospital stays, reduced complications, and improved patient outcomes, which are crucial in resource-constrained settings to minimize surgery-related costs. Therefore, implementing ERAS protocols in Ethiopia is not only feasible but may also have a greater impact than in high-income countries, leading to improved outcomes for patients undergoing surgeries. However, there is a lack of research on the implementation and impact of ERAS protocols in Ethiopia. Further research is needed to assess the specific challenges and opportunities for implementing ERAS protocols in Ethiopia's healthcare system. Aim This study aims to assess the efficacy of strict adherence to an ERAS element recommended in the national perioperative guidelines through a bundled approach, known as the "Triple Intervention Strategy", on the postoperative outcomes of patients undergoing laparotomy and caesarian section surgical procedures in Ethiopia. The strategy includes three ERAS interventions: starting postoperative feeding and drinking, early ambulation, and early removal of a urinary catheter.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 13/01/2025
Actual trial start date 13/01/2025
Anticipated date of last follow up 11/02/2025
Actual Last follow-up date 11/02/2025
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Postoperative ERAS protocol Not applicable one month Patients who met the inclusion criteria will start - early feeding, immediate intake of clear fluid and solids after 4 hours but not more than 12 hours, - early urinary catheter removal within the first 24 hours, and - initiation of ambulation within the first 24 hours post-surgery. 500
Control Group Routine care Not applicable One Month In this group patient will undergo routine care in the postoperative care. There will be no innervation to initiate early diet, exercise and catheter removal. 500 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Laparotomy surgeries and cesarean sections and gynecology surgery - Age greater or equal to 18 years - Willing to participate in the study - Patients who died in the Table (Intraoperative death) - Patient admitted to the ICU directly after surgery or referred to other facilities - Patients who have undergone surgical procedures other than CS and laparotomy - Patients whose age are less than 18 (not sure I am to include all above 14 but need evidence for that) 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2024 UNIVERSITY OF CAPE TOWN Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
D23/GSH Main road Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/08/2024 Arba Minch University Institutional Research Ethics Review Board Office
Ethics Committee Address
Street address City Postal code Country
Arba Minch Ethiopia Arba Minch 21 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome length of hospital stays, which will be compared between the intervention and control groups. At discharge time
Secondary Outcome postoperative complications At discharge time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Network for Perioperative and Critical care Not applicable Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Cape Town Department of Anaesthesia and Perioperative Medicine D23/GSH Main road Cape Town 7700 South Africa
Network for Perioperative and Critical Care Debre Berhan University Asrat Woldeyes Health Sciences Campus Debre Berhan Debre Berhan 445 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Network for Perioperative and Critical Care Debre Berhan University Asrat Woldeyes Health Sciences Campus Debre Berhan Debre Berhan 445 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Desta Galcha Arba Minch Arba Minch 21 Ethiopia
Peniel Kenna Addis Ababa Addis Ababa 1000 Ethiopia
Beti Muleye Addis Ababa Addis Ababa 1000 Ethiopia
Ermiyas Belay Addis Ababa Sidist Killo Addis Ababa 1000 Ethiopia
Prof Salome Maswime D23/GSH Main road Cape Town 7700 South Africa
Prof Bruce Biccard D23/GSH Main road Cape Town 7700 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fitsum Belachew fitsum@n4pcc.com 0919829303 Not applicable
City Postal code Country Position/Affiliation
Adiss Ababa Ethiopia Lead Researcher
Role Name Email Phone Street address
Public Enquiries Peniel Dula peniel@n4pcc.com +251948300930 Not applicable
City Postal code Country Position/Affiliation
Adiss Ababa Ethiopia Trial Administrator
Role Name Email Phone Street address
Scientific Enquiries Ermias Belay ermiyasbelay03@gmail.com +25124000776 Not applicable
City Postal code Country Position/Affiliation
Adiss Ababa Ethiopia Biostatistician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share de-identified IPD that underpins the results of this study with researchers or other organizations upon reasonable request. The data shared will exclude any information that could potentially identify participants, ensuring full compliance with data privacy regulations. Statistical Analysis Plan January 2026 The de-identified IPD will be available to global health academics, including but not limited to researchers in the field of surgery, anesthesia, and perioperative medicine. Requests must specify the intended use of the IPD and be submitted to the Principal Investigator (PI) for review. If further inquiries or clarifications are required, the PI or research team will reach out to the requester. Otherwise, requests that align with ethical and scientific standards will be processed and granted accordingly.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 22/01/2025 As discussed above. ERAS Trial in Bellwether surgical procedures: Randomized Pragmatic Cluster Trial ERAS Trial in Bellwether surgical procedures: Randomized Pragmatic Cluster Trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 29/01/2025 I have now revised the title to align with the title on the ethics approval letters. Thank you. ERAS Trial in Bellwether surgical procedures: Randomized Pragmatic Cluster Trial Optimizing Surgical Care in Ethiopia: Assessing ERAS Implementation, Evaluating Outcomes, and Examining Economic Impact
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 20/01/2025 PACTR Admin 13 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 22/01/2025 I can confirm now that we have ticked all the applicable age groups up to that of the maximum age. Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/01/2025 I was asked to submit the ethics approval letter from Ethiopia, where the recruitment is taking place. One of the study collaborators applied for this ethics committee, hence the name listed as PI is his, while the others, including mine, are designated as collaborators. TRUE, Arba Minch University Institutional Research Ethics Review Board Office , Arba Minch Ethiopia , Arba Minch, 21, Ethiopia, , 21 Aug 2024, +251468810279, irb.amu@yahoo.com, 33295_30447_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 29/01/2025 The reason for the change in the IPD description is to align the statement with the specific requirements for study registration, as clarified by the feedback received. The original description focused on sharing summarized results and ensuring transparency in reporting, which is common for publications but does not satisfy the requirement for an IPD sharing statement. Once the trial analysis is complete and results are generated, we must share our findings with the global community to ensure transparency and reproducibility, thereby contributing to the advancement of scientific knowledge and fostering collaboration among researchers worldwide. We intend to share de-identified IPD that underpins the results of this study with researchers or other organizations upon reasonable request. The data shared will exclude any information that could potentially identify participants, ensuring full compliance with data privacy regulations.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 29/01/2025 The Key Access Criteria is updated to clarify the process for requesting and reviewing access to de-identified IPD. It will be open for the global health academics, including but not limited to surgery/anesthesia residents, fellows, or researchers in the perioperative area.The request must specify the reason for the IPD. Upon receiving the request, the PI and research team will review it. If further inquiries are needed, the PI will reach out; otherwise, the request will be processed accordingly. The de-identified IPD will be available to global health academics, including but not limited to researchers in the field of surgery, anesthesia, and perioperative medicine. Requests must specify the intended use of the IPD and be submitted to the Principal Investigator (PI) for review. If further inquiries or clarifications are required, the PI or research team will reach out to the requester. Otherwise, requests that align with ethical and scientific standards will be processed and granted accordingly.