Saudi Emergency Laparotomy Audit (SELA): A National Multicenter Observational Audit of Outcomes Following Emergency Laparotomy in Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- 30-day all-cause mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Emergency Laparotomy Cohort
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.
干预措施: Emergency Laparotomy (Procedure)
结局指标
主要结局
30-day all-cause mortality
时间窗: 30 days following the date of emergency laparotomy
All-cause mortality occurring within 30 days of emergency laparotomy, determined from hospital records and follow-up documentation as part of the retrospective audit.
次要结局
- Postoperative ICU admission(From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days)
- Repeat Laparotomy(From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days)
- Postoperative complications(From date of emergency laparotomy until hospital discharge or in-hospital death (up to 90 days))
- Length of hospital stay(From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days)
- 90-day all-cause mortality(90 days following the date of emergency laparotomy)
研究者
Haytham Alabbas
Consultant
King Faisal Specialist Hospital & Research Center