Post-operative ComplicationsSurgPASSNCT06932653
Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
A study testing SurgPASS - intervention in people with Post-operative Complications, run by University of Birmingham at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Complications
- What is being tested?
- SurgPASS - intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Jun 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Minimally invasive surgery
- Surgery for appendicitis
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Benin1 site
University of Abomey-Calavi, Abomey-Calavi
Cotonou
Ismail Lawani, ismaillawani@gmail.com
Ghana1 site
Tamale Teaching Hospital, Tamale
Tamale
Stephen Tabiri, kstephenba14@gmail.com
India1 site
Christian Medical College (CMC) & Hospital, Ludhiana, Ludhiana, 141008
Ludhiana
Parvez Haque, pdhaque@gmail.com
Nigeria1 site
Lagos University Teaching Hospital (Hub), Lagos
Lagos
Adesoji Ademuyiwa, adesojiademuyiwa@yahoo.co.uk
Rwanda1 site
University Teaching Hospital of Kigali (Hub), Kigali
Kigali
Faustin Ntirenganya, fostino21@yahoo.fr
About this study
Official title: SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised 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.
Read the 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
- Conditions
- Post-operative Complications
- Being tested
- SurgPASS - intervention
- Keywords
- pilot, cluster, surgical safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgPASS - interventionOther
SurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Surgpass checklist and training champions | Experimental | A preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions. Receives: Other: SurgPASS - intervention |
| Comparator - usual care | No intervention | Usual care as per local practice at that site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training and checklist completion
Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot cluster randomised trial.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lagos State University, Christian Medical College and Hospital, Ludhiana, India, University Teaching Hospital of Kigali, Ministry of Health, Ghana, Université d'Abomey-Calavi
- Responsible party
- Sponsor
- Investigators
- Aneel Bhangu, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932653
- Sponsor's protocol ID
- SurgPASS
- Acronym
- SurgPASS
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT06932653
- Acronym / sponsor ID
- SurgPASS / SurgPASS
- Conditions
- Post-operative Complications
- Keywords
- pilot, cluster, surgical safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Lagos State University, Christian Medical College and Hospital, Ludhiana, India, University Teaching Hospital of Kigali, Ministry of Health, Ghana, Université d'Abomey-Calavi
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot cluster randomised trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Surgpass checklist and training champions | Experimental | Other: SurgPASS - interventionA preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions. |
| Comparator - usual care | No intervention | –Usual care as per local practice at that site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Minimally invasive surgery
- Surgery for appendicitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgPASS - interventionSurgPASS consists of a preoperative surgical passport used for any patients requiring emergency laparotomy, a simulation training course and local clinical champions. | Other | Intervention - Surgpass checklist and training champions |
Primary outcome
Training and checklist completion
Time frame: Within 30 days postoperatively
Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aneel Bhangu principal investigator
University of Birmingham
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurgPASS - intervention in people with Post-operative Complications, run by University of Birmingham at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Benin, Ghana, India, Nigeria, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Lillywhite (+44 (0)121 415 9103, r.e.lillywhite@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training and checklist completion (time frame: Within 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.