Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360666
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-11
First Post:
2024-03-26
Brief Title:
Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia
Sponsor:
Asst Melegnano e Martesana
Organization:
Asst Melegnano e Martesana
Study Overview
Official Title:
Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEURAX
Brief Summary:
The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery The main question it aims to answer is
Does general anesthesia lower complications compared to loco-regional anesthesia keeping the patient spontaneously breathing and sedated in laparoscopic abdominal major surgery Participants are followed for neurological sequelae for 90 days following surgery
Does general anesthesia lower complications compared to loco-regional anesthesia keeping the patient spontaneously breathing and sedated in laparoscopic abdominal major surgery Participants are followed for neurological sequelae for 90 days following surgery
Detailed Description:
BACKGROUND Laparoscopic abdominal surgery has historically required general anesthesia However the use of general anesthetics has neurological effects including the risk of postoperative neurological disorders Cognitive impairments amnesia cognitive delay postoperative cognitive dysfunction difficulty in resuming daily activities occur in variable percentages of patients based on the type and dosage of anesthetics duration of exposure cerebral perfusion pressure baseline cognitive status and patient age Mechanical ventilation during general anesthesia often leads to lung atelectasis compounded by reduced diaphragmatic excursion due to laparoscopic insufflation potentially impacting tissue oxygenation and leading to postoperative complications General anesthetics also have negative inotropic and chronotropic effects affecting tissue perfusion and increasing the risk of neurological and surgical complications and cardiovascular events
The increasing complexity of surgical techniques and patient comorbidities necessitates exploring alternatives to general anesthesia particularly for fragile patients undergoing laparoscopic abdominal surgery Regional anesthesia techniques have been advocated to provide effective anesthesia while minimizing neurological cardiovascular and respiratory impacts thereby improving clinical outcomes and functional recovery
RATIONALE Given the significant impact of anesthesia on postoperative complications in fragile patients undergoing laparoscopic abdominal surgery we aim to develop an anesthetic strategy that optimizes clinical and functional outcomes especially in terms of preserving neurocognitive and respiratory function by reducing reliance on general anesthetics This has led us to reconsider regional anesthesia as an alternative during laparoscopic abdominal surgery
STUDY DESIGN This is a retrospective observational cohort clinical study monocentric with analysis of previous months following acquisition of study consent and follow-up
Each patient underwent preoperative evaluation with a standard anesthesiology visit based on national and international guidelines SIAARTI-ERAS-ESC Additionally preoperative neurologic status was assessed using the Mental Test delirium assessment with NU-Desc and Frailty Scale Lung ultrasound assessment was routinely performed on the day of surgery see attached assessment scores before the start of anesthesia procedures and again 2 hours after surgery completion Patients were sedated with non-GABAergic anesthetics targeting RASS 0-2
Data related to procedures performed anesthetic techniques used complications radiological and laboratory reports will be extracted anonymously from the Dedalus O4C T4Health and TrackCare applications
Information in aggregated form and stratified by type of procedure will be collected in a Microsoft Excel database and used for subsequent statistical analysis
FOLLOW-UP At 1 and 3 months during routine post-operative visits patients were assessed for neurologic status Mental Test delirium assessment with NU-Desc Frailty Scale Mortality was assessed at 3 months post-surgery Patients followed at other centers were contacted by phone to assess neurologic status and mortality
STATISTICAL ANALYSIS Data were treated anonymously and managed using an electronic Case Report Form eCRF developed with the Microsoft Excel platform Data related to neurologic reassessments during follow-ups are reported in the data collection sheet developed using Microsoft Excel
Statistical analysis will be performed using MedCalc version 20118 32-bit Appropriate statistical tests including ANOVA Chi-square test and T-test will be used where applicable Continuous variables will be expressed as mean standard deviation categorical variables as percentages Variables with a p-value 005 will be considered statistically significant
RESULTS PUBLICATION Publication of study data will occur upon study completion
ETHICALLEGAL ASPECTS
91 ACCE Approval A copy of the patients informed consent must be submitted to the Ethics Committee EC along with the protocol for written approval Written approval of the protocol and informed consent must be obtained before patient recruitment begins
EC favorable opinion must be obtained before the trial starts The researcher should inform the EC of any protocol amendments which must be approved by the EC
92 Informed Consent All eligible patients will be asked for informed consent to participate in the study
93 Personal Data Handling Personal data collected must comply with the European General Data Protection Regulation GDPR Legislative Decree 1962003 and subsequent amendments and any other applicable Italian laws for personal data protection applicable data protection law
The Promoter will handle personal data provided in a pseudo-anonymized form in compliance with applicable data protection law
The Promoter will implement necessary measures to comply with applicable data protection law and implement appropriate technical and organizational measures to ensure GDPR compliance
The Promoter is responsible for providing Principal Investigators and Research Personnel with necessary information regarding how the Promoter will collect and manage their personal data before such information is provided
The Promoter ensures correct handling of personal data as required by the GDPR If a data breach involving personal data is identified the user must promptly notify other users within 24 hours of becoming aware of the breach In such cases the user must cooperate fully to remedy the data breach fulfill mandatory notification within specified timeframes and manage any resulting damage
Data breach involving personal data is defined in articles 33 and 34 of the GDPR
DATA COLLECTION MANAGEMENT AND STORAGE CRF The study will be conducted in accordance with the Helsinki Declaration and in compliance with good clinical practice norms Ministerial Decree of Health dated 15071997 and subsequent amendments and applicable regulatory provisions
The Promoter will appropriately maintain clinical records and research data in compliance with section 49 of ICH-GCP E6 regulatory agency provisions and institution regulations to ensure patient confidentiality protection As a participant in a clinical study the Promoter will allow authorized personnel and regulatory agencies to review and when permitted by law copy clinical records for data quality checks audits safety evaluations and study progress assessments
Source documents include all information original records of clinical findings observations or other activities necessary for the reconstruction and evaluation of the clinical study Examples include but are not limited to medical records clinical charts laboratory notebooks memoranda patient diaries or assessment lists drug dispensing records data recorded by automated instruments certified copies or transcriptions verified for accuracy and completeness microfiche photographic negatives microfilm or magnetic media X-ray films subject cards and records kept in pharmacies laboratories and technical-medical departments involved in the clinical study
Data collection is the responsibility of personnel at the study center under the supervision of the centers Principal Investigator The Case Report Form CRF is the primary tool for data collection The researcher should ensure accuracy completeness legibility and timeliness of data entered into the CRF and other relevant data Data recorded in the CRF derived from source documents must match the originals and any discrepancies should be explained All required CRF data must be recorded and any missing data must be explained Any changes or corrections to a paper CRF must be dated initialed by the compiler explained if necessary and not obscure the original data The researcher should track changes and corrections made to CRFs
The researcherinstitution should maintain study documents as specified in Essential Documents for Conducting a Clinical Study ICH-GCP E6 section 8 and as required by regulatory agencies and guidelines Measures should be taken to prevent accidental or premature destruction of documentation
Essential documents written and electronic should be retained for at least fifteen 15 years from study completion unless the Promoter provides written authorization to dispose of or retain data for an additional period if permitted by law regulatory agencies andor guidelines
The increasing complexity of surgical techniques and patient comorbidities necessitates exploring alternatives to general anesthesia particularly for fragile patients undergoing laparoscopic abdominal surgery Regional anesthesia techniques have been advocated to provide effective anesthesia while minimizing neurological cardiovascular and respiratory impacts thereby improving clinical outcomes and functional recovery
RATIONALE Given the significant impact of anesthesia on postoperative complications in fragile patients undergoing laparoscopic abdominal surgery we aim to develop an anesthetic strategy that optimizes clinical and functional outcomes especially in terms of preserving neurocognitive and respiratory function by reducing reliance on general anesthetics This has led us to reconsider regional anesthesia as an alternative during laparoscopic abdominal surgery
STUDY DESIGN This is a retrospective observational cohort clinical study monocentric with analysis of previous months following acquisition of study consent and follow-up
Each patient underwent preoperative evaluation with a standard anesthesiology visit based on national and international guidelines SIAARTI-ERAS-ESC Additionally preoperative neurologic status was assessed using the Mental Test delirium assessment with NU-Desc and Frailty Scale Lung ultrasound assessment was routinely performed on the day of surgery see attached assessment scores before the start of anesthesia procedures and again 2 hours after surgery completion Patients were sedated with non-GABAergic anesthetics targeting RASS 0-2
Data related to procedures performed anesthetic techniques used complications radiological and laboratory reports will be extracted anonymously from the Dedalus O4C T4Health and TrackCare applications
Information in aggregated form and stratified by type of procedure will be collected in a Microsoft Excel database and used for subsequent statistical analysis
FOLLOW-UP At 1 and 3 months during routine post-operative visits patients were assessed for neurologic status Mental Test delirium assessment with NU-Desc Frailty Scale Mortality was assessed at 3 months post-surgery Patients followed at other centers were contacted by phone to assess neurologic status and mortality
STATISTICAL ANALYSIS Data were treated anonymously and managed using an electronic Case Report Form eCRF developed with the Microsoft Excel platform Data related to neurologic reassessments during follow-ups are reported in the data collection sheet developed using Microsoft Excel
Statistical analysis will be performed using MedCalc version 20118 32-bit Appropriate statistical tests including ANOVA Chi-square test and T-test will be used where applicable Continuous variables will be expressed as mean standard deviation categorical variables as percentages Variables with a p-value 005 will be considered statistically significant
RESULTS PUBLICATION Publication of study data will occur upon study completion
ETHICALLEGAL ASPECTS
91 ACCE Approval A copy of the patients informed consent must be submitted to the Ethics Committee EC along with the protocol for written approval Written approval of the protocol and informed consent must be obtained before patient recruitment begins
EC favorable opinion must be obtained before the trial starts The researcher should inform the EC of any protocol amendments which must be approved by the EC
92 Informed Consent All eligible patients will be asked for informed consent to participate in the study
93 Personal Data Handling Personal data collected must comply with the European General Data Protection Regulation GDPR Legislative Decree 1962003 and subsequent amendments and any other applicable Italian laws for personal data protection applicable data protection law
The Promoter will handle personal data provided in a pseudo-anonymized form in compliance with applicable data protection law
The Promoter will implement necessary measures to comply with applicable data protection law and implement appropriate technical and organizational measures to ensure GDPR compliance
The Promoter is responsible for providing Principal Investigators and Research Personnel with necessary information regarding how the Promoter will collect and manage their personal data before such information is provided
The Promoter ensures correct handling of personal data as required by the GDPR If a data breach involving personal data is identified the user must promptly notify other users within 24 hours of becoming aware of the breach In such cases the user must cooperate fully to remedy the data breach fulfill mandatory notification within specified timeframes and manage any resulting damage
Data breach involving personal data is defined in articles 33 and 34 of the GDPR
DATA COLLECTION MANAGEMENT AND STORAGE CRF The study will be conducted in accordance with the Helsinki Declaration and in compliance with good clinical practice norms Ministerial Decree of Health dated 15071997 and subsequent amendments and applicable regulatory provisions
The Promoter will appropriately maintain clinical records and research data in compliance with section 49 of ICH-GCP E6 regulatory agency provisions and institution regulations to ensure patient confidentiality protection As a participant in a clinical study the Promoter will allow authorized personnel and regulatory agencies to review and when permitted by law copy clinical records for data quality checks audits safety evaluations and study progress assessments
Source documents include all information original records of clinical findings observations or other activities necessary for the reconstruction and evaluation of the clinical study Examples include but are not limited to medical records clinical charts laboratory notebooks memoranda patient diaries or assessment lists drug dispensing records data recorded by automated instruments certified copies or transcriptions verified for accuracy and completeness microfiche photographic negatives microfilm or magnetic media X-ray films subject cards and records kept in pharmacies laboratories and technical-medical departments involved in the clinical study
Data collection is the responsibility of personnel at the study center under the supervision of the centers Principal Investigator The Case Report Form CRF is the primary tool for data collection The researcher should ensure accuracy completeness legibility and timeliness of data entered into the CRF and other relevant data Data recorded in the CRF derived from source documents must match the originals and any discrepancies should be explained All required CRF data must be recorded and any missing data must be explained Any changes or corrections to a paper CRF must be dated initialed by the compiler explained if necessary and not obscure the original data The researcher should track changes and corrections made to CRFs
The researcherinstitution should maintain study documents as specified in Essential Documents for Conducting a Clinical Study ICH-GCP E6 section 8 and as required by regulatory agencies and guidelines Measures should be taken to prevent accidental or premature destruction of documentation
Essential documents written and electronic should be retained for at least fifteen 15 years from study completion unless the Promoter provides written authorization to dispose of or retain data for an additional period if permitted by law regulatory agencies andor guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None