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

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Saudi Arabia
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Faisal Specialist Hospital & Research Center

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.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2251788

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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