SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Birmingham
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- Training and checklist completion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
Given this is a cluster trial, blinding of participants are not relevant as the entire cluster will be randomised to either the intervention or usual care.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: SurgPASS - intervention (Other)
Comparator - usual care
Usual care as per local practice at that site.
Outcomes
Primary Outcomes
Training and checklist completion
Time Frame: Within 30 days postoperatively
Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)
Secondary Outcomes
No secondary outcomes reported