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

NCT06932653 · tracked via the Priya Life Science India tracker

Sponsor

University of Birmingham

Phase

Not applicable

Started

2025-06-01

Last updated

2025-04-17

Condition(s) studied

Post-operative Complications

Investigational drug(s) / intervention(s)

SurgPASS - intervention

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Training and checklist completion — Within 30 days postoperatively
Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)

Trial sites (5)

Facility	City	Region
University of Abomey-Calavi, Abomey-Calavi	Cotonou	Benin
Tamale Teaching Hospital, Tamale	Tamale	Ghana
Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008	Ludhiana	India
Lagos University Teaching Hospital (Hub), Lagos	Lagos	Nigeria
University Teaching Hospital of Kigali (Hub), Kigali	Kigali	Rwanda

More University of Birmingham trials in India

Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery Recruiting

A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI Starting soon

A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06932653 on ClinicalTrials.gov ↗ ← All trials in India