Saudi Emergency Laparotomy Audit

Official title

Saudi Emergency Laparotomy Audit (SELA): A National Multicenter Observational Audit of Outcomes Following Emergency Laparotomy in Saudi Arabia

Overview

The Saudi Emergency Laparotomy Audit (SELA) is a national, multicenter observational clinical audit designed to evaluate outcomes and quality of care for patients undergoing emergency laparotomy in Saudi Arabia. The audit will collect standardized data on patient characteristics, comorbidities, perioperative processes, and postoperative outcomes through a retrospective baseline phase followed by a prospective registry phase. SELA aims to establish national benchmarks, assess applicability of international risk models, support development of a Saudi-specific risk prediction tool, and drive quality improvement through systematic feedback and benchmarking across participating hospitals.

Detailed description

The Saudi Emergency Laparotomy Audit (SELA) is a national, multicenter observational clinical audit designed to systematically evaluate outcomes and quality of care for patients undergoing emergency laparotomy in Saudi Arabia. Emergency laparotomy is associated with substantial morbidity and mortality, yet outcome data within the country are currently fragmented, heterogeneous, and largely limited to single-center reports. SELA aims to address this gap by establishing a standardized national audit framework based exclusively on retrospective data collection.

SELA will be conducted as a retrospective annual audit, with participating hospitals submitting data on all eligible emergency laparotomy cases performed during defined audit periods. Data will be extracted from routinely collected clinical records, including emergency department documentation, operative notes, anesthesia records, laboratory systems, and inpatient and critical care charts. No prospective recruitment, real-time data entry, or deviation from standard clinical care will occur.

The audit will capture standardized variables covering patient demographics, comorbidities, preoperative physiological and biochemical status, operative characteristics, perioperative process measures, and postoperative outcomes, including short- and intermediate-term mortality and morbidity. A unified data dictionary with predefined variable definitions will be used to ensure consistency across centers and audit cycles. SELA is strictly non-interventional, with no assigned treatments or modifications to existing clinical pathways.

SELA is designed as a recurring quality improvement initiative. Annual retrospective audit cycles will allow benchmarking of hospital-level and national outcomes, assessment of variations in care delivery, and monitoring of trends over time. De-identified aggregated data will be used to evaluate the applicability of established international risk models and to support development and refinement of Saudi-specific risk stratification tools based on local population characteristics.

The long-term objective of SELA is to establish a sustainable national audit infrastructure that supports continuous quality improvement, informs health system planning and resource allocation, enables multicenter research, and contributes to evidence-based policy and guideline development for emergency general surgery in Saudi Arabia.

Interventions

• Procedure Emergency Laparotomy
  Emergency laparotomy performed as part of routine clinical care for acute intra-abdominal surgical conditions. This audit observes outcomes following emergency laparotomy without altering standard perioperative management, with data collected retrospectively from existing clinical records.

Primary outcome measures

• 30-day all-cause mortality [Time frame: 30 days following the date of emergency laparotomy]

Secondary outcome measures (5)

• 90-day all-cause mortality [Time frame: 90 days following the date of emergency laparotomy]
• Postoperative complications [Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death (up to 90 days)]
• Length of hospital stay [Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days]
• Postoperative ICU admission [Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days]
• Repeat Laparotomy [Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days]

Eligibility criteria

Inclusion criteria

• Age ≥14 years
• Undergoing an emergency (E1-E4) laparotomy, laparoscopy, or laparoscopically-assisted abdominal operation
• Procedures involving the stomach, small bowel, large bowel, or rectum for acute pathology (e.g., perforation, ischemia, abscess, bleeding, or obstruction)
• Washout/evacuation of intra-peritoneal abscess or hematoma (excluding those secondary to appendicitis or cholecystitis)
• Bowel resection or repair for obstructed/incarcerated hernias with acute presentation (incisional, umbilical, inguinal, femoral)
• Adhesiolysis (open or laparoscopic)
• Trauma-related emergency abdominal procedures
• Inoperable pathology where a definitive operative procedure was intended (not purely diagnostic)
• Return to theatre for major wound dehiscence ("burst abdomen")
• Complications requiring general surgical intervention following interventional radiology procedures
• Complications requiring general surgical intervention following gynecological oncology surgery
• Complications following elective or non-elective general/upper GI surgery, where the above criteria are met

Exclusion criteria

• Age <14 years
• Elective laparotomy or laparoscopy
• Diagnostic-only laparotomy or laparoscopy (unless abandoned due to inoperable disease)
• Appendicectomy or cholecystectomy (including their complications), unless incidental to a more major non-elective gastrointestinal procedure
• Non-elective hernia repair without bowel resection or adhesiolysis
• Minor wound dehiscence repair (unless bowel resection is required)
• Stoma formation via trephine or laparoscopic approach (include only if midline laparotomy is the primary procedure)
• Vascular, obstetric, gynecological (except gynecological oncology complications requiring general surgery input), transplant, hepatobiliary, urological, renal, pancreatic, or splenic procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Saudi Arabia · 1 center

• King Faisal Specialist Hospital & Research Centre — Jeddah

Publications

• Ingraham AM, Richards KE, Hall BL, Ko CY. Quality improvement in surgery: the American College of Surgeons National Surgical Quality Improvement Program approach. Adv Surg. 2010;44:251-67. doi: 10.1016/j.yasu.2010.05.003. PMID 20919525
• Vester-Andersen M, Lundstrom LH, Moller MH, Waldau T, Rosenberg J, Moller AM; Danish Anaesthesia Database. Mortality and postoperative care pathways after emergency gastrointestinal surgery in 2904 patients: a population-based cohort study. Br J Anaesth. 2014 May;112(5):860-70. doi: 10.1093/bja/aet487. Epub 2014 Feb 10. PMID 24520008
• GlobalSurg Collaborative. Mortality of emergency abdominal surgery in high-, middle- and low-income countries. Br J Surg. 2016 Jul;103(8):971-988. doi: 10.1002/bjs.10151. Epub 2016 May 4. PMID 27145169
• Saunders DI, Murray D, Pichel AC, Varley S, Peden CJ; UK Emergency Laparotomy Network. Variations in mortality after emergency laparotomy: the first report of the UK Emergency Laparotomy Network. Br J Anaesth. 2012 Sep;109(3):368-75. doi: 10.1093/bja/aes165. Epub 2012 Jun 22. PMID 22728205

Identifiers

NCT: NCT07429929 · 2251788

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗