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

Overview

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.

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

Interventions

Eligibility

Locations (5)

Outcomes

Central Contacts