Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial

Not Applicable

Not yet recruiting

• Conditions: Post-operative Complications

• Registration Number: NCT06932653
• Lead Sponsor: University of Birmingham

Brief Summary

SurgPASS is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. If SurgPASS is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.

Detailed Description

Title: Reducing deaths after surgery in low- and middle-income countries: A pilot cluster randomised trial

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

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-06-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Training and checklist completion	Within 30 days postoperatively	Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)

Trial Locations

Locations (5)

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