Health Trials

Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial

ConditionPost-operative Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Minimally invasive surgery

Surgery for appendicitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • SurgPASS - intervention

    Other intervention

    SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Intervention - Surgpass checklist and training championsExperimental treatment 1 intervention
Group B: Comparator - usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

1

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
2

Complication rates

Measure 30-day overall complication rates to inform overall sample size of potential full trial

Time frame
Within 30 days postoperatively

Sponsors and contacts

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University of Birmingham

Lead sponsor

Lagos State University

Collaborator

Christian Medical College and Hospital, Ludhiana

Collaborator

University Teaching Hospital of Kigali

Collaborator

Ministry of Health, Ghana

Collaborator

Université d'Abomey-Calavi

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: