How well three surgical risk calculators can predict 30-day mortality after emergency abdominal surgery: a retrospective study from Northeastern Romania
| ISRCTN | ISRCTN14537109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14537109 |
| Sponsor | Universitatea de Medicina și Farmacie Grigore T. Popa - Iași |
| Funder | Universitatea de Medicina și Farmacie Grigore T. Popa - Iasi |
- Submission date
- 03/12/2025
- Registration date
- 30/12/2025
- Last edited
- 30/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Emergency laparotomy is a high-risk surgical procedure with significant mortality, especially in patients over 70. Risk prediction scores, such as NELA, ACS-NSQIP, and SORT, are commonly used internationally to estimate postoperative mortality, but their performance in Romania has not been evaluated. This study aims to compare the predicted 30-day mortality generated by these tools with the actual observed mortality in Romanian patients who underwent emergency laparotomy between 2022 and 2023. It also aims to assess long-term survival and identify the most common emergency procedures associated with a high mortality risk.
Who can participate?
The study includes adults aged 18 and over who underwent emergency abdominal surgery (laparotomy or laparoscopy) in one of six hospitals in Northeastern Romania between January 1, 2022, and December 31, 2023. Patients are included based on the standard eligibility criteria defined by the National Emergency Laparotomy Audit (NELA).
What does the study involve?
This is a retrospective observational study. Data will be collected from hospital records and will include patient demographics, surgical details, risk scores, and outcomes. The date of death will be ascertain by medical records scrutiny, contacting the general practitioner and as a last resort contacting the family. No intervention or treatment will be given as part of this study.
What are the possible benefits and risks of participating?
There are no direct benefits or risks for patients, as all data are collected retrospectively. However, the findings may help improve risk prediction and surgical care for future patients undergoing emergency laparotomy.
Where is the study run from?
The study is coordinated by “Grigore T. Popa” University of Medicine and Pharmacy in Iași, Romania, and involves six hospitals in the Northeastern region.
When is the study starting and how long is it expected to run for?
The study period covers surgeries performed from January 2022 to December 2023. Data collection is scheduled for September - December 2025.
Who is funding the study?
The study is funded by a doctoral grant from “Grigore T. Popa” University of Medicine and Pharmacy, Iași (Romania).
Who is the main contact?
Dr Iordache Gabriel-Andi, PhD Student
andi.iordache@umfiasi.ro
Contact information
Scientific, Principal investigator, Public
Department of General and Upper GI Surgery, Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 0QQ
United Kingdom
 ORCID ID |
0000-0002-1105-443X |
|---|---|
| Phone | +447928927762 |
| andrei.moscalu@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre retrospective longitudinal cohort study |
| Secondary study design | Cohort study |
| Scientific title | A retrospective longitudinal observational study of observed and predicted 30-day mortality after emergency laparotomy using NELA, ACS-NSQIP, and SORT risk scores in six hospitals in Northeastern Romania (Mortality In Romania: Real vs. predicted Outcomes in emeRgency laparotomy) |
| Study acronym | MIRRoR |
| Study objectives | To determine the actual 30-day postoperative mortality following emergency laparotomy performed in six hospitals in Northeastern Romania and to compare it with mortality predictions generated by three preoperative risk assessment tools: NELA, ACS-NSQIP, and SORT. Analyses will be conducted for the entire cohort and stratified by age (<70 vs. ≥70 years). This is the first retrospective national initiative to evaluate the performance of these models in Romanian surgical practice. |
| Ethics approval(s) |
Approved 22/12/2025, Ethics Committee of the “Grigore T. Popa” University of Medicine and Pharmacy of Iași (Str. Universității nr. 16, Iași, 700115, Romania; +40 232 301 603; eticacercetarii@umfiasi.ro), ref: 691 / 22.12.2025. |
| Health condition(s) or problem(s) studied | Emergency general surgical conditions requiring laparotomy, including gastrointestinal perforation, bowel ischemia, intra-abdominal abscess, gastrointestinal bleeding, and mechanical obstruction. The study focuses on postoperative mortality following emergency laparotomy. |
| Intervention | This is a multicentre, retrospective, longitudinal cohort study conducted across six hospitals in Northeastern Romania, including two tertiary-level centres. The study includes adult patients (≥18 years) who underwent emergency laparotomy between January 1, 2022, and December 31, 2023. Data are collected retrospectively from medical records, and the primary outcome is 30-day postoperative mortality. The observed mortality will be compared with that predicted by three risk assessment tools: NELA, ACS-NSQIP, and SORT. |
| Intervention type | Not Specified |
| Primary outcome measure(s) |
1. 30-day postoperative mortality is measured using hospital records at 30 days after surgery |
| Key secondary outcome measure(s) |
Survival status is measured using Kaplan-Meier survival analysis at 3, 6, 12, 24, and 36 months postoperatively |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 1500 |
| Total final enrolment | 1512 |
| Key inclusion criteria | 1. Adults aged 18 years and older 2. Open, laparoscopic, or laparoscopically-assisted abdominal procedures performed in an expedited, urgent, or emergency setting (as defined by NCEPOD) 3. Procedures involving the stomach, small bowel, colon, or rectum 4. Cases involving: gastrointestinal perforation, intestinal ischaemia, intra-abdominal abscess, gastrointestinal haemorrhage, or mechanical obstruction 5. All procedures where appendicitis is the primary diagnosis, regardless of severity or extent 6. Laparotomy or enterotomy for gallstone ileus 7. Any laparotomy or laparoscopy undertaken for primary oesophageal pathology 8. Emergency laparotomy/laparoscopy for gastric pathologies, including haemorrhage, hiatal hernia repair, and removal of foreign bodies or gastric bands 9. Emergency procedures for bleeding duodenal ulcers, gallstone ileus, or foreign body removal from the small intestine 10. Emergency surgery for colorectal pathology, including iatrogenic perforations post-endoscopy 11. Emergency formation of a colostomy or ileostomy as a primary procedure via midline laparotomy 12. Return to theatre for major abdominal wound dehiscence (“burst abdomen”) 13. Emergency laparotomy for bowel ischaemia not preceded by primary vascular or endovascular intervention 14. Return to theatre requiring general surgical assistance following gynaecology-oncology surgery 15. Washout or drainage of peritoneal abscess or haematoma 16. Emergency repair of inguinal, femoral, incisional, or parastomal hernias involving adhesiolysis or bowel resection/repair 17. Laparotomy or laparoscopy undertaken exclusively for adhesiolysis 18. Any abdominal procedure performed for blunt or penetrating trauma, including laparotomy for foreign body removal from the sigmoid or rectum 19. All procedures related to organ transplantation, including reoperations 20. Any reoperation for complications following elective upper gastrointestinal or colorectal procedures meeting NELA criteria, and returns to theatre involving general surgical assistance following gynaecology-oncology surgery or interventional radiology procedures |
| Key exclusion criteria | 1. Children under 18 years 2. Elective (non-emergency) surgical procedures 3. Diagnostic laparotomy/laparoscopy where no therapeutic procedure is performed due to inoperable findings (e.g., peritoneal or hepatic metastases, non-viable ischaemic bowel) 4. Surgeries targeting the oesophagus, spleen, kidneys, liver, gallbladder, biliary tract, pancreas, or urinary tract 5. Any primary surgery of the gallbladder or biliary tract, unless incidental to a major gastrointestinal procedure 6. Iatrogenic gastric perforation following endoscopic procedures 7. Foreign body removal from the colon or rectum (considered trauma cases) 8. Emergency stoma formation via trephine incision or laparoscopic approach 9. Minor or superficial wound dehiscence unless it results in bowel pathology necessitating resection 10. Laparotomies for primary vascular pathologies or complications following vascular procedures, regardless of whether bowel resection was performed 11. Laparotomies for primary gynaecological pathology, including ruptured ectopic pregnancy or pelvic abscess due to pelvic inflammatory disease 12. Returns to theatre for complications of gynaecological surgery unless involving gastrointestinal complications secondary to gynaecology-oncology procedures 13. Any procedure related to pancreatitis, removal of peritoneal dialysis catheters, or washout/drainage procedures related to appendicectomy, cholecystectomy, or vascular/urological/gynaecological surgery 14. Emergency hernia repairs not involving adhesiolysis or bowel resection/repair 15. All procedures related to organ transplantation, including reoperations 16. Returns to theatre for complications following non-gastrointestinal surgery (e.g., renal, urological, vascular, hepatic, pancreatic, oesophageal, or splenic surgery), except where complications follow gynaecology-oncology surgery or interventional radiology and require general surgical intervention |
| Date of first enrolment | 23/12/2025 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- Romania
Study participating centres
Iași
700111
Romania
Suceava
720237
Romania
Galați
800578
Romania
Fălticeni
725200
Romania
Pașcani
705200
Romania
Bârlad
731054
Romania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 29/12/2025 | No | No |
Additional files
- 48605_Protocol.pdf
- Protocol file
Editorial Notes
29/12/2025: Study’s existence confirmed by the Ethics Committee of Sf. Spiridon Emergency Clinical Hospital, Iasi County, Romania.
