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

Inclusion criteria

• Patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm
• Patient must not be pregnant
• Adults only (greater than or equal to 18 years old)

Exclusion criteria

• Minimally invasive surgery
• Surgery for appendicitis