An interventional study of SurgPASS - intervention in Post-operative Complications, sponsored by University of Birmingham. Not yet recruiting at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by University of Birmingham · Not applicable, Interventional, and Other
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.
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.
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.
University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
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Exclusion criteria:
A preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.
Other: SurgPASS - intervention
Usual care as per local practice at that site.
SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.
Training and checklist completion
Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)
Time frame: Within 30 days postoperatively
Duration of time to recruit sample size per cluster
Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial)
Time frame: Within 6 months post cluster activation
Complication rates
Measure 30-day overall complication rates to inform overall sample size of potential full trial
Time frame: Within 30 days postoperatively
Plan to share: No — 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).
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Dec 2025, 6 months later.
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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