Quality Improvement Audit of ERAS Protocol Adherence in Emergency Laparotomy

NCT06757127 | Completed

• 2 other identifiers: ALNAO-EC-2024-09ANH/EC/2024/082
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The percentage of compliance with ERAS protocol criteria across preoperative, intraoperative, and postoperative phases.

  The percentage of compliance with ERAS protocol criteria across preoperative, intraoperative, and postoperative phases

  From enrollment to 30 days post-intervention for each phase (pre-intervention and post-intervention phases)

Study Arms (2)

Pre-Intervention Assessment of Staff Adherence to ERAS Protocol in Emergency Laparotomy

OTHER

This arm involves evaluating the baseline adherence of healthcare staff, including doctors, nurses, and anesthesia technicians, to the ERAS protocols for emergency laparotomy patients. Data collection was exclusively based on direct observation to assess adherence accurately while minimizing any observer effect that might alter staff behavior. A checklist based on ERAS ® Society guidelines for emergency laparotomy, tailored to the resource constraints of the setting, was used to assess compliance with criteria across preoperative, intraoperative, and postoperative phases. No intervention was applied during this phase, serving as a baseline for comparison with post-intervention outcomes

Other: ERAS Protocol Adaptation for Emergency Laparotomy

Post-Intervention Assessment of Staff Adherence to ERAS Protocol in Emergency Laparotomy

NO INTERVENTION

This arm evaluates the adherence of healthcare staff to the ERAS protocol following the implementation of a quality improvement intervention. The same criteria checklist was used to assess compliance across the preoperative, intraoperative, and postoperative phases. This phase aims to measure the impact of the training and identify improvements in compliance rates compared to the pre-intervention assessment.

Interventions

ERAS Protocol Adaptation for Emergency Laparotomy OTHER

The intervention incorporated a comprehensive quality improvement approach, including a presentation, live demonstrations, and an instructional video to support the implementation of ERAS protocols. These methods emphasized the key components outlined by the ERAS ® Society guidelines for emergency laparotomy, ensuring that participants understood the importance of each protocol step and its application in clinical practice. As part of the quality improvement initiative, efforts were made to engage key stakeholders, including local governance and healthcare authorities, to align the intervention with policy frameworks. Training materials, including videos and manuals, were reviewed by a consultant surgeon to ensure accuracy and relevance. Additionally, a consultant surgeon conducted individual demonstrations in the operating room and ward, supplemented by weekly morning meetings with nurses, anesthesiologists, residents, and doctors for one month.

Pre-Intervention Assessment of Staff Adherence to ERAS Protocol in Emergency Laparotomy

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sudan Medical Specialization Board: lead

Study Sites (1)

Alnao Teaching Hospital

Khartoum, Omdurman, Sudan

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Alsadig Suliman, MBBS, Msc

  Sudan Medical Specialization Board

  PRINCIPAL INVESTIGATOR

• Aamir Hamza, Prof Surgery

  University of Bahri

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 15, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)