Post-operative Complications
Conditions
Keywords
pilot, cluster, surgical safety
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
Interventions
OTHERSurgPASS - intervention
SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.
Sponsors
Lagos State University
Christian Medical College and Hospital, Ludhiana
University Teaching Hospital of Kigali
Ministry of Health, Ghana
Université d'Abomey-Calavi
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
Pilot cluster randomised trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of time to recruit sample size per cluster | Within 6 months post cluster activation | Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial) |
| Complication rates | Within 30 days postoperatively | Measure 30-day overall complication rates to inform overall sample size of potential full trial |
Countries
Benin, Ghana, India, Nigeria, Rwanda
Contacts
Primary ContactRachel Lillywhite
Backup ContactDivya Kapoor
Outcome results
None listed