Enhanced surgical safety checklist implementation to improve safety culture among surgical and anesthesiology residents in a Romanian tertiary hospital
| ISRCTN | ISRCTN88241350 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88241350 |
| Sponsor | Ovidius University |
| Funder | Investigator initiated and funded |
- Submission date
- 24/02/2026
- Registration date
- 26/02/2026
- Last edited
- 26/02/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Viorel Gherghina
Scientific, Principal investigator, Public
Scientific, Principal investigator, Public
Tomis 147 Bl A3 Sc C Ap 46
Constanta
900502
Romania
| 0000-0002-8695-6104 | |
| Phone | +40 745222615 |
| viorel.gherghina@365365univ-ovidius.ro |
Ms Iuliana Cîndea
Scientific
Scientific
Faculty of Medicine, Ovidius University of Constanta
Constanta
900502
Romania
| iulia.cindea@365univ-ovidius.ro |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Non-randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Health services research, This study aims to assess the impact of an enhanced Surgical Safety Checklist educational program on safety culture perceptions among surgical and anesthesiology residents. | |
| Scientific title | Enhanced surgical safety checklist implementation improves safety culture among surgical and anesthesiology residents: a prospective interventional study in a resource-limited tertiary hospital | |
| Study objectives | Primary objective To determine whether an enhanced Surgical Safety Checklist implementation strategy improves safety culture perceptions (teamwork climate and safety climate SAQ domains) among surgical and anesthesiology residents after six months Secondary objectives 1. To assess Surgical Safety Checklist compliance rates following enhanced implementation 2. To identify predictors of improvement in safety culture perceptions among residents | |
| Ethics approval(s) |
Approved 15/06/2024, Ethics Committee of the Emergency Clinical Hospital of Constanta (Bulevardul Tomis 145, Constanța, 900591, Romania; +40 241 503 245; spitaljudetean_cta@gmail.com), ref: 113/2024 | |
| Health condition(s) or problem(s) studied | Patient safety culture in surgical care | |
| Intervention | Implementation of an enhanced Surgical Safety Checklist program including: Interactive SSC training session (2-hour structured education with simulation scenarios). Structured postoperative feedback forms completed by residents after procedures. Biweekly interdisciplinary mentorship sessions with senior surgeons and anesthesiologists. Duration of intervention: 6 months. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 24 Years |
| Upper age limit | 40 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | Surgical and anesthesiology-intensive care residents rotating in the operating theatre of a tertiary emergency hospital during the study period and providing written informed consent. |
| Key exclusion criteria | Prior formal Surgical Safety Checklist training or fewer than 10 operating theatre shifts during the study period. |
| Date of first enrolment | 01/07/2024 |
| Date of final enrolment | 31/07/2024 |
Locations
Countries of recruitment
- Romania
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
25/02/2026: Trial's existence confirmed by Emergency Clinical Hospital of Constanta.