Clinical trial NCT06757127: Quality Improvement Audit of ERAS Protocol Adherence in Emergency Laparotomy
Official title: Enhancing Surgical Outcomes with a Closed-Loop Audit of ERAS Protocols in Emergency Laparotomy At a Conflict-Affected Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Laparotomy
Quality Improvement
Implementation Science
Enhanced Recovery After Surgery (ERAS) Protocol
Keywords: Enhanced Recovery After Surgery (ERAS)
Emergency Laparotomy
Resource-Limited Settings
Patient-Centered Care
Audit and Compliance
Surgical Care Optimization
Lead sponsor: Sudan Medical Specialization Board
Sponsor class: OTHER_GOV
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: This study evaluates the implementation of Enhanced Recovery After Surgery (ERAS) protocols during emergency laparotomy procedures in a resource-limited hospital in Sudan. ERAS protocols are evidence-based guidelines designed to improve patient outcomes by reducing surgical stress and optimizing care across preoperative, intraoperative, and postoperative phases.

The audit will included adult patients and assessed adherence to ERAS society criteria tailored to local constraints. Data were collected through direct observations. A quality improvement and intervention was implemented, involving live demonstrations, instructional videos, and illustrated manuals to enhance staff understanding and compliance with the protocols.

By addressing gaps in protocol adherence and overcoming barriers such as resource limitations and knowledge gaps, the study highlights the feasibility of adapting ERAS protocols to emergency settings in low-resource environments, aiming to improve surgical care and patient outcomes.

Detailed description: This study examines adherence to ERAS protocols during emergency laparotomy procedures in a resource-limited hospital in Sudan. While traditionally associated with elective surgeries, this study focuses on their adaptation to emergency laparotomies, which present unique challenges due to their urgency and complexity.

The study was conducted as a single-center, prospective clinical audit from, involving adult patients undergoing emergency laparotomy. The ERAS criteria assessed were tailored to the hospital's limited resources and encompassed criteria elements spanning preoperative, intraoperative, and postoperative phases. These criteria were designed to address critical aspects of patient care, such as early warning system usage, sepsis management, risk assessment, fluid and electrolyte correction, and patient education.

The study methodology included data collection in two phases: a pre-intervention phase to establish baseline compliance and a post-intervention phase following the implementation of a quality improvement initiative. The initiative involved extensive training for staff, including live demonstrations, instructional videos, and illustrated manuals, aimed at standardizing and improving protocol adherence.

Data collection was exclusively based on direct observation to assess adherence accurately while minimizing any observer effect that might alter staff behavior. Compliance with each criterion was assessed using a binary scoring system (compliant = 1, non-compliant = 0). The checklist was adapted from the ERAS Society guidelines, modified to fit the constraints of a low-resource setting, and underwent a pilot phase to ensure clarity and practicality.

The audit team consisted of eight members, including doctors, nurses, and an anesthesia technician, all trained to standardize data collection and scoring methods. Interventions emphasized practical applications of ERAS protocols in emergency settings and engaged key stakeholders to align improvements with institutional policies.

This study highlights the challenges of implementing ERAS protocols in resource-constrained environments, focusing on adapting these evidence-based practices to enhance patient care and improve surgical outcomes in emergency scenarios. By addressing barriers such as limited supplies, inadequate training, and workflow constraints, the study provides insights into the feasibility of scaling ERAS protocols in similar settings.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 59 years
* Underwent emergency laparotomy due to trauma

Exclusion Criteria:

* Patients who died during surgery or subsequent hospitalization
* Patients with incomplete medical records
* Patients who required re-laparotomy due to complications from previous surgeries
* Patients taking chronic anticoagulants

Primary outcomes:
measure: The percentage of compliance with ERAS protocol criteria across preoperative, intraoperative, and postoperative phases.
timeFrame: From enrollment to 30 days post-intervention for each phase (pre-intervention and post-intervention phases)
Secondary outcomes:
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Alnao Teaching Hospital
state: Omdurman
Study officials:
affiliation: Sudan Medical Specialization Board
name: Alsadig Suliman, MBBS, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bahri
name: Aamir Hamza, Prof Surgery
role: STUDY_CHAIR
References: