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

NCT06932653 | Not Yet Recruiting

• 1 other identifier: SurgPASS
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 5

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.

Conditions

Post-operative Complications

Keywords

pilot; cluster; surgical safety

Outcome Measures

Primary Outcomes (1)

• Training and checklist completion

  Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)

  Within 30 days postoperatively

Other Outcomes (2)

• Duration of time to recruit sample size per cluster

  Within 6 months post cluster activation

• Complication rates

  Within 30 days postoperatively

Study Arms (2)

Intervention - Surgpass checklist and training champions

EXPERIMENTAL

A preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.

Other: SurgPASS - intervention

Comparator - usual care

NO INTERVENTION

Usual care as per local practice at that site.

Interventions

SurgPASS - intervention OTHER

SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.

Intervention - Surgpass checklist and training champions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Minimally invasive surgery
• Surgery for appendicitis

Sponsors & Collaborators

• University of Birmingham: lead
• Lagos State University: collaborator
• Christian Medical College and Hospital, Ludhiana: collaborator
• University Teaching Hospital of Kigali: collaborator
• Ministry of Health, Ghana: collaborator
• Université d'Abomey-Calavi: collaborator

Study Sites (5)

University of Abomey-Calavi, Abomey-Calavi

Cotonou, Benin

Location

Tamale Teaching Hospital, Tamale

Tamale, Ghana

Location

Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008

Ludhiana, India

Location

Lagos University Teaching Hospital (Hub), Lagos

Lagos, Nigeria

Location

University Teaching Hospital of Kigali (Hub), Kigali

Kigali, Rwanda

Location

Study Officials

• Aneel Bhangu

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Lillywhite

CONTACT

+44 (0)121 415 9103; r.e.lillywhite@bham.ac.uk

Divya Kapoor

CONTACT

+44 (0)121 415 9103; d.kapoor@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot cluster randomised trial.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1); NG (1); RW (1); IN (1); BE (1)