NCT07429929

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

February 7, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

February 7, 2026

Last Update Submit

February 22, 2026

Conditions

LaparotomyLaparotomy SurgeryEmergency TreatmentAbdominal DiseasesGastrointestinal DiseasesIntestinal ObstructionIntestinal Obstruction and IleusIntestinal PerforationIntestinal IschemiaPeritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative ComplicationsPeritonitis BacterialPeritonitis Caused by Perforated Left-sided Colon DiverticulitisPeritonitis InfectiousSepsisPostoperative Complications After Gastrointestinal OperationsSurgical Procedures, OperativeMortality

Keywords

Emergency laparotomySurgical auditPostoperative outcomesPerioperative careMortalityMorbidityQuality improvementRisk stratificationRetrospective auditSaudi Arabia

Outcome Measures

Primary Outcomes (1)

  • 30-day all-cause mortality

    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 Outcomes (5)

  • 90-day all-cause mortality

    90 days following the date of emergency laparotomy

  • 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

  • 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

Study Arms (1)

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

Interventions

Emergency LaparotomyPROCEDURE

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.

Emergency Laparotomy Cohort

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Faisal Specialist Hospital & Research Centre

Jeddah, Mecca Region, 23433, Saudi Arabia

Location

Related Publications (4)

  • 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.

    PMID: 20919525BACKGROUND

  • 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.

    PMID: 24520008BACKGROUND

  • 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.

    PMID: 27145169BACKGROUND

  • 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.

    PMID: 22728205BACKGROUND

Related Links

MeSH Terms

Conditions

Gastrointestinal DiseasesIntestinal ObstructionIleusIntestinal PerforationPostoperative ComplicationsSepsis

Condition Hierarchy (Ancestors)

Digestive System DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammation

Central Study Contacts

Haytham AlAbbas, FRCSC

CONTACT

00966567323272HALABBAS@kfshrc.edu.sa

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 24, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

SA(1)