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How well three surgical risk calculators can predict 30-day mortality after emergency abdominal surgery: a retrospective study from Northeastern Romania

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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14537109
Enrollment
1500
Registered
2025-12-30
Start date
2025-12-23
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. Surgery

Interventions

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 yea

Sponsors

Universitatea de Medicina ?i Farmacie Grigore T. Popa - Ia?i
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. 30-day postoperative mortality is measured using hospital records at 30 days after surgery 2. Predicted mortality using NELA score is measured using NELA risk calculator at preoperative baseline 3. Predicted mortality using ACS-NSQIP score is measured using ACS-NSQIP risk calculator at preoperative baseline 4. Predicted mortality using SORT score is measured using SORT risk calculator at preoperative baseline

Secondary

MeasureTime frame
Survival status is measured using Kaplan-Meier survival analysis at 3, 6, 12, 24, and 36 months postoperatively

Countries

Romania

Contacts

Public ContactAndrei Moscalu
andrei.moscalu@nhs.net+447928927762

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026