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Clinical Trial NCT06932653 (SurgPASS) for Post-operative Complications is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
University of BirminghamReducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial (SurgPASS)
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
SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
- SurgPASS
cluster
surgical safety
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIntervention - 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. | 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 InterventionComparator - usual care Usual care as per local practice at that site. | N/A |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
- 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)
- Minimally invasive surgery
- Surgery for appendicitis
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