An observational study in Laparotomy, Laparotomy Surgery and Emergency Treatment, sponsored by King Faisal Specialist Hospital & Research Center. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by King Faisal Specialist Hospital & Research Center · Observational
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.
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 350 across 147 observational studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →King Faisal Specialist Hospital & Research Center is the lead sponsor of 99 studies on the registry; 18 are open to participants now.
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The study population consists of all eligible patients aged 14 years and older who underwent emergency laparotomy or emergency laparoscopic abdominal surgery at participating hospitals in Saudi Arabia during the defined retrospective audit period. Patients are identified through hospital records and include those operated on for acute intra-abdominal surgical conditions such as gastrointestinal perforation, obstruction, ischemia, bleeding, sepsis, and related emergencies requiring non-elective abdominal surgery. The audit includes consecutive cases meeting predefined inclusion criteria and excludes elective procedures and non-eligible surgical specialties, with data collected retrospectively from routinely documented clinical, operative, and postoperative records.
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Exclusion Criteria:
This cohort includes all eligible patients undergoing emergency laparotomy at participating hospitals during the defined retrospective audit period. Patients are identified through hospital records and include non-elective abdominal surgical procedures performed for acute intra-abdominal pathology, with data collected retrospectively from routinely documented clinical, operative, and postoperative records.
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.
30-day all-cause mortality
All-cause mortality occurring within 30 days of emergency laparotomy, determined from hospital records and follow-up documentation as part of the retrospective audit.
Time frame: 30 days following the date of emergency laparotomy
90-day all-cause mortality
All-cause mortality occurring within 90 days of emergency laparotomy, identified through hospital records and follow-up documentation during the retrospective audit period.
Time frame: 90 days following the date of emergency laparotomy
Postoperative complications
Occurrence of postoperative complications following emergency laparotomy, as documented in inpatient records, including surgical, medical, and critical care-related complications.
Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death (up to 90 days)
Length of hospital stay
Total duration of hospital stay following emergency laparotomy, calculated from the date of surgery to the date of discharge or in-hospital death.
Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days
Postoperative ICU admission
Requirement for postoperative admission to the intensive care unit following emergency laparotomy, as documented in clinical and critical care records.
Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days
Repeat Laparotomy
Requirement for unplanned return to the operating theatre for re-laparotomy following the index emergency laparotomy.
Time frame: From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days
Plan to share: No — Individual participant data (IPD) will not be shared. The study is a retrospective national clinical audit using de-identified routinely collected data, conducted under institutional approvals with strict data governance, confidentiality, and role-based access controls. Data sharing is restricted to aggregated and anonymized analyses for audit reporting and approved research outputs in accordance with institutional and regulatory policies.
Start is estimated for Jun 2026; primary completion for Dec 2027, 18 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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King Faisal Specialist Hospital & Research Center