Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SurgPASS - intervention.
- Who it may be relevant to
- Registry conditions: Post-operative Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Benin, Ghana, India, Nigeria, Rwanda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
Overview
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
- Other SurgPASS - intervention
SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.
Primary outcome measures
- Training and checklist completion [Time frame: Within 30 days postoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Benin · 1 center
- University of Abomey-Calavi, Abomey-Calavi — Cotonou
Ghana · 1 center
- Tamale Teaching Hospital, Tamale — Tamale
India · 1 center
- Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008 — Ludhiana
Nigeria · 1 center
- Lagos University Teaching Hospital (Hub), Lagos — Lagos
Rwanda · 1 center
- University Teaching Hospital of Kigali (Hub), Kigali — Kigali
Identifiers
NCT: NCT06932653 · SurgPASS