NCT06932653

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Post-operative Complications

Interventions

Type	Name	Description
OTHER	SurgPASS - intervention	SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

5 sites across 5 countries: Benin, Ghana, India, Nigeria, Rwanda