An interventional study of ERAS Protocol Adaptation for Emergency Laparotomy in Emergency Laparotomy, Quality Improvement and Implementation Science, sponsored by Sudan Medical Specialization Board. Completed at 1 site in Sudan. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Sudan Medical Specialization Board · Not applicable, Interventional, and Screening
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.
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.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
This study's enrollment of 40 is below the median of 116 across 527 interventional studies indexed under Patient Compliance.
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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
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.
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.
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
Time frame: From enrollment to 30 days post-intervention for each phase (pre-intervention and post-intervention phases)
Plan to share: No — Due to limitations in resources and infrastructure, we do not have a mechanism to securely share IPD at this time. Additionally, our ethical and regulatory approvals do not cover IPD sharing.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Sudan Medical Specialization Board