Clinical trial NCT06932653: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
Official title: SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-operative Complications
Keywords: pilot
cluster
surgical safety
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Lagos State University
name: Christian Medical College and Hospital, Ludhiana
name: University Teaching Hospital of Kigali
name: Ministry of Health, Ghana
name: Université d'Abomey-Calavi
First posted: 2025-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot cluster randomised trial.
Primary purpose: OTHER

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.

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

Eligibility criteria: 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 outcomes:
measure: Training and checklist completion
timeFrame: Within 30 days postoperatively
Secondary outcomes:
Other outcomes:
measure: Duration of time to recruit sample size per cluster
timeFrame: Within 6 months post cluster activation
measure: Complication rates
timeFrame: Within 30 days postoperatively
Locations:
city: Cotonou
country: Benin
facility: University of Abomey-Calavi, Abomey-Calavi
city: Tamale
country: Ghana
facility: Tamale Teaching Hospital, Tamale
city: Ludhiana
country: India
facility: Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital (Hub), Lagos
city: Kigali
country: Rwanda
facility: University Teaching Hospital of Kigali (Hub), Kigali
Study officials:
affiliation: University of Birmingham
name: Aneel Bhangu
role: PRINCIPAL_INVESTIGATOR
References: