Saudi Emergency Laparotomy Audit (SELA)

February 22, 2026 updated by: Haytham Alabbas, King Faisal Specialist Hospital & Research Center

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

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.

Study Overview

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

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Mecca Region
      • Jeddah, Mecca Region, Saudi Arabia, 23433
        • King Faisal Specialist Hospital & Research Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 7, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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