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

April 10, 2025 updated by: University of Birmingham

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Comparator - usual care
Usual care as per local practice at that site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within 30 days postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of time to recruit sample size per cluster
Time Frame: Within 6 months post cluster activation
Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial)
Within 6 months post cluster activation
Complication rates
Time Frame: Within 30 days postoperatively
Measure 30-day overall complication rates to inform overall sample size of potential full trial
Within 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Lagos State University
Université d'Abomey-Calavi
Tamale Teaching Hospital, Tamale, Ghana
Christian Medical College and Hospital, Ludhiana
University Teaching Hospital of Kigali

Investigators

  • Principal Investigator: Aneel Bhangu, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SurgPASS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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