Emergency LaparotomyNCT06757127
Quality Improvement Audit of ERAS Protocol Adherence in Emergency Laparotomy
A study testing ERAS Protocol Adaptation for Emergency Laparotomy in people with Emergency Laparotomy and Quality Improvement, run by Sudan Medical Specialization Board at 1 site in Sudan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Emergency Laparotomy, Quality Improvement, Implementation Science
- What is being tested?
- ERAS Protocol Adaptation for Emergency Laparotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSudan
- Study dates
- 1 Feb 2024to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 59 years
- Underwent emergency laparotomy due to trauma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Surgical Outcomes with a Closed-Loop Audit of ERAS Protocols in Emergency Laparotomy At a Conflict-Affected Hospital
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.
Read the 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.
- Conditions
- Emergency Laparotomy, Quality Improvement, Implementation Science, Enhanced Recovery After Surgery (ERAS) Protocol
- Being tested
- ERAS Protocol Adaptation for Emergency Laparotomy
- Keywords
- Enhanced Recovery After Surgery (ERAS), Emergency Laparotomy, Resource-Limited Settings, Patient-Centered Care, Audit and Compliance, Surgical Care Optimization
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS Protocol Adaptation for Emergency LaparotomyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 30 days post-intervention for each phase (pre-intervention and post-intervention phases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Feb 2024
- Primary completion1 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudan Medical Specialization Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alsadig Suliman, Sudan Medical Specialization Board
- Investigators
- Alsadig Suliman, MBBS, Msc, Principal investigator, Sudan Medical Specialization BoardAamir Hamza, Prof Surgery, Study chair, University of Bahri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757127
- Sponsor's protocol ID
- ALNAO-EC-2024-09
- Other IDs
- ANH/EC/2024/082
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Surgical Outcomes with a Closed-Loop Audit of ERAS Protocols in Emergency Laparotomy At a Conflict-Affected Hospital
- ClinicalTrials.gov ID
- NCT06757127
- Acronym / sponsor ID
- ALNAO-EC-2024-09
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sudan Medical Specialization BoardOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Assessment of Staff Adherence to ERAS Protocol in Emergency Laparotomy | Other | Other: ERAS Protocol Adaptation for Emergency LaparotomyThis 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 |
| 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 59 years
- Underwent emergency laparotomy due to trauma
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS Protocol Adaptation for Emergency LaparotomyThe 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. | Other | Pre-Intervention Assessment of Staff Adherence to ERAS Protocol in Emergency Laparotomy |
Primary outcome
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)
The percentage of compliance with ERAS protocol criteria across preoperative, intraoperative, and postoperative phases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alsadig Suliman, MBBS, Msc principal investigator
Sudan Medical Specialization Board
Aamir Hamza, Prof Surgery study chair
University of Bahri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS Protocol Adaptation for Emergency Laparotomy in people with Emergency Laparotomy and Quality Improvement, run by Sudan Medical Specialization Board at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.