Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
NCT ID: NCT06932653
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2025-06-01
2026-01-31
Brief Summary
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Detailed Description
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Aim: This pilot randomised cluster trial aims to evaluate the feasibility of a large-scale cluster randomised trial to assess the effectiveness and implementation of a pre-operative checklist to reduce deaths after surgery. If this pilot study is successful, we aim to assess the intervention in a separate full-scale cluster randomised trial.
* Objective 1: To determine feasibility and fidelity of delivering the intervention.
* Objective 2: To determine the rate recruitment to inform how long it will take to recruit to a future cluster randomised trial.
* Objective 3: To obtain information on postoperative outcomes to help inform the outcomes used and sample size of the future cluster randomised trial.
Design: Pilot cluster randomised trial.
Inclusion: Adult (\>18 years old) non-pregnant patients undergoing emergency abdominal surgery with an incision of ≥5cm.
Exclusion: Patients undergoing minimally invasive surgery, or surgery for appendicitis.
Intervention: SurgPASS is an intervention of a preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.
Comparator: Usual care as per local practice at that site.
Follow-up period: 30-days from surgery.
Number of participants: 300 participants: 25 participants in each of 12 clusters (hospitals), from 6 countries.
Outcomes: Since this is a pilot study, there are no pre-specified primary outcomes. However, there are four key outcomes of interest to assess ahead of the main phase randomised clinical trial.
* Outcome 1: Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)
* Outcome 2: Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial)
* Outcome 3: Measure 30-day overall complication rates to inform overall sample size of potential full trial
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention - Surgpass checklist and training champions
A preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.
SurgPASS - intervention
SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.
Comparator - usual care
Usual care as per local practice at that site.
No interventions assigned to this group
Interventions
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SurgPASS - intervention
SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.
Eligibility Criteria
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Inclusion Criteria
* Patient must not be pregnant
* Adults only (greater than or equal to 18 years old)
Exclusion Criteria
* Surgery for appendicitis
18 Years
ALL
No
Sponsors
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Lagos State University
OTHER
Christian Medical College and Hospital, Ludhiana
UNKNOWN
University Teaching Hospital of Kigali
UNKNOWN
Ministry of Health, Ghana
OTHER_GOV
Université d'Abomey-Calavi
OTHER
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Aneel Bhangu
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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University of Abomey-Calavi, Abomey-Calavi
Cotonou, , Benin
Tamale Teaching Hospital, Tamale
Tamale, , Ghana
Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008
Ludhiana, , India
Lagos University Teaching Hospital (Hub), Lagos
Lagos, , Nigeria
University Teaching Hospital of Kigali (Hub), Kigali
Kigali, , Rwanda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SurgPASS
Identifier Type: -
Identifier Source: org_study_id
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