Health TrialsbyHealthPanel

Saudi Emergency Laparotomy Audit

ConditionsLaparotomyLaparotomy 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
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorKing Faisal Specialist Hospital & Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Emergency Laparotomy

    Procedure/Surgery

    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.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Emergency Laparotomy Cohort1 intervention

Trial outcomes

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.

Time frame
30 days following the date of emergency laparotomy

Secondary outcomes

1

90-day all-cause mortality

All-cause mortality occurring within 90 days of emergency laparotomy, identified through hospital records and follow-up documentation during the retrospective audit period.

Time frame
90 days following the date of emergency laparotomy
2

Postoperative complications

Occurrence of postoperative complications following emergency laparotomy, as documented in inpatient records, including surgical, medical, and critical care-related complications.

Time frame
From date of emergency laparotomy until hospital discharge or in-hospital death (up to 90 days)
3

Length of hospital stay

Total duration of hospital stay following emergency laparotomy, calculated from the date of surgery to the date of discharge or in-hospital death.

Time frame
From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days
4

Postoperative ICU admission

Requirement for postoperative admission to the intensive care unit following emergency laparotomy, as documented in clinical and critical care records.

Time frame
From date of emergency laparotomy until hospital discharge or in-hospital death, assessed up to 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Faisal Specialist Hospital & Research Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: