- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429929
Saudi Emergency Laparotomy Audit (SELA)
Saudi Emergency Laparotomy Audit (SELA): A National Multicenter Observational Audit of Outcomes Following Emergency Laparotomy in Saudi Arabia
Study Overview
Status
Conditions
- Gastrointestinal Diseases
- Sepsis
- Mortality
- Intestinal Obstruction
- Peritonitis Infectious
- Laparotomy
- Emergency Treatment
- Intestinal Ischemia
- Intestinal Perforation
- Surgical Procedures, Operative
- Peritonitis Caused by Perforated Left-sided Colon Diverticulitis
- Intestinal Obstruction and Ileus
- Laparotomy Surgery
- Peritonitis Bacterial
- Abdominal Diseases
- Postoperative Complications After Gastrointestinal Operations
- Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Haytham AlAbbas, FRCSC
- Phone Number: 00966567323272
- Email: HALABBAS@kfshrc.edu.sa
Study Locations
-
-
Mecca Region
-
Jeddah, Mecca Region, Saudi Arabia, 23433
- King Faisal Specialist Hospital & Research Centre
-
Contact:
- Donya Bahussain
- Phone Number: 00966553400509
- Email: dbahussain@kfshrc.edu.sa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day all-cause mortality
Time Frame: 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.
|
30 days following the date of emergency laparotomy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
90-day all-cause mortality
Time Frame: 90 days following the date of emergency laparotomy
|
All-cause mortality occurring within 90 days of emergency laparotomy, identified through hospital records and follow-up documentation during the retrospective audit period.
|
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)
|
Occurrence of postoperative complications following emergency laparotomy, as documented in inpatient records, including surgical, medical, and critical care-related complications.
|
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
|
Total duration of hospital stay following emergency laparotomy, calculated from the date of surgery to the date of discharge or in-hospital death.
|
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
|
Requirement for postoperative admission to the intensive care unit following emergency laparotomy, as documented in clinical and critical care records.
|
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
|
Requirement for unplanned return to the operating theatre for re-laparotomy following the index emergency laparotomy.
|
From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Br J Surg. 2017 Apr;104(5):632. doi: 10.1002/bjs.10463.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2251788
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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