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NCT Number: NCT07429929

Saudi Emergency Laparotomy Audit

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emergency laparotomy

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haytham AlAbbas, FRCSC

CONTACT

[email protected]

00966567323272

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

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

Acronym: SELA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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