Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

Clinical Outcomes and Institutional Integration of the ERAS (Enhanced Recovery After Surgery) Protocol in Pediatric Appendicetomies: A Mixed Methodological IDEAL (Idea, Development, Exploration, Assessment, Long-term Study) 2a Preliminary Study

Acute appendicitis is the most common surgical emergency in children. Despite the widespread adoption of laparoscopic appendectomy, postoperative care still varies widely between institutions, with prolonged fasting, opioid-based analgesia, delayed feeding, and routine drain placement being common. Enhanced Recovery After Surgery (ERAS) is an evidence-based, multidisciplinary care pathway that has been shown in adults - and increasingly in children - to reduce length of stay, opioid consumption, and postoperative complications.

This single-center, prospective, single-arm cohort feasibility study (IDEAL Stage 2a) tests whether a comprehensive 20-item pediatric ERAS protocol, adapted for minimally invasive appendectomy in children aged 5-18 with non-complicated acute appendicitis (ASA I-II), can be implemented with high fidelity and acceptable safety in a tertiary academic pediatric surgery department. We aim to enroll 100 patients to obtain ~80 evaluable cases. The primary endpoint is the global ERAS compliance rate (target ≥80%, with the lower bound of the 95% confidence interval staying above 70%). Co-primary safety endpoints include Clavien-Dindo ≥III complications and 30-day unplanned readmission rates, both targeted at <5%. Secondary endpoints include time to medical readiness for discharge, actual length of stay, opioid sparing, and parent-reported outcomes.

The study includes a structured run-in phase (first 5 patients) with explicit decision logic to either continue with the protocol unchanged or revise it before full enrollment. Audit-and-feedback cycles every 20 patients monitor compliance drift. The findings will inform a definitive institutional clinical guideline and provide hypothesis-generating data for future multi-center trials.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Appendicitis; Pediatric Surgery; ERAS; Appendectomy, Laparoscopic
• Intervention / Treatment: Other: Comprehensive 20-Item Pediatric ERAS Protocol

Detailed Description

Background and Rationale Acute appendicitis affects roughly 1 in 10 children in their lifetime and remains the leading cause of emergency abdominal surgery in pediatric populations. Although laparoscopic appendectomy has become the standard of care for non-complicated cases, perioperative practice patterns vary substantially. Routine prolonged preoperative fasting, opioid-based postoperative analgesia, delayed enteral feeding, and the prophylactic use of nasogastric tubes, abdominal drains, and urinary catheters persist in many institutions despite evidence to the contrary. This unwarranted clinical variation prolongs recovery, increases adverse events, and exposes children to avoidable opioid exposure.

Enhanced Recovery After Surgery (ERAS) protocols package multiple evidence-based perioperative interventions into a coordinated multidisciplinary care pathway. Adult ERAS programs have consistently demonstrated reductions in complications, length of stay, and resource utilization. Pediatric ERAS adoption has lagged but is accelerating, particularly in colorectal, urological, and now general surgical contexts. Most pediatric ERAS reports to date, however, focus on elective procedures - applying ERAS to a time-pressured, emergent context like acute appendicitis introduces operational challenges (limited preoperative optimization window, variable family preparation, fluctuating staffing) that must be tested locally before adoption.

Conceptual Framework This study follows the IDEAL Framework Stage 2a (Development) for surgical innovation: a structured, prospective evaluation of a defined protocol in a single center, with explicit revision logic and transparent reporting. Implementation science elements are integrated through (a) Knowledge-Attitudes-Practice (KAP) surveys before and after the pilot, (b) a CFIR 2.0-informed barriers assessment, and (c) NoMAD-based normalization process measures. The study is registered as observational (cohort, prospective) consistent with the absence of randomization or experimental drug/device assignment; the "exposure" is the institutional ERAS protocol applied to consecutive eligible patients.

The 20-Item ERAS Protocol

The protocol spans the perioperative pathway in three blocks:

Preoperative (5 items): ERAS counseling and family education; avoidance of prolonged fasting (clear fluids permitted up to 2 hours; solids ≥6 hours); no oral carbohydrate loading (acute appendicitis context); no mechanical bowel preparation; restricted sedative premedication.

Intraoperative (9 items): timely prophylactic antibiotics (within 30-60 min of incision); regional analgesia with 0.25% bupivacaine port-site infiltration; short-acting anesthetic agents; restricted intraoperative opioid (<0.1 mg/kg morphine equivalent); active normothermia (core temp >36 °C); goal-directed euvolemic fluid therapy (3-7 mL/kg/h crystalloid, zero balance target); minimally invasive surgical approach; avoidance of routine drains/tubes; universal PONV prophylaxis (ondansetron + dexamethasone 0.15 mg/kg, max 8 mg).

Postoperative (6 items): early NG tube removal; early oral feeding (clear fluids within 2-4 hours; staged advancement to age-appropriate diet); early IV fluid discontinuation (saline lock once 100 mL tolerated orally); early mobilization (out of bed by hour 4, corridor walk by hour 6); multimodal scheduled "zigzag" oral analgesia (paracetamol 15 mg/kg PO q6h alternating with ibuprofen 10 mg/kg PO q6h, every 3 hours); criterion-based discharge planning.

Decision Algorithms

Three algorithms standardize bedside decisions:

• PONV cascade (3 levels: nausea → 30-min pause; first emesis → rescue antiemetic from a different receptor class with 1-hour wait then re-challenge from clear fluids; clinically significant emesis → suspend ERAS feeding goals, restart IV maintenance, surgical reassessment for ileus/mechanical/leak);
• Rescue analgesia (triggered by VAS ≥5 in patients ≥7 years or FLACC ≥5 in <7 years on two consecutive measurements 30 minutes apart, despite scheduled paracetamol+ibuprofen; managed with low-dose IV opioid recorded as rescue, not as a protocol deviation);
• Medical Readiness for Discharge (MRD): a six-criterion checklist (tolerating ≥Phase 2 diet without vomiting; oral analgesia adequate VAS/FLACC <4; age-appropriate ambulation; spontaneous urine output; family preparedness; physiologic stability with SpO2 >95% on room air, temperature <38 °C in last 4 hours, vital signs within PALS limits). Notably, gas/stool passage is explicitly NOT an MRD criterion. After MRD, patients enter a brief "in-hospital home simulation" phase before actual discharge to measure the institutional/cultural delay (Δ time = T-discharge - T-MRD).

Run-in Phase and Decision Gate

Per IDEAL Stage 2a methodology, the first 5 enrolled patients constitute a Run-in (Vanguard) phase. After the 5th patient, the leadership team conducts an Early Safety and Compliance Audit:

• Decision A (Protocol Stable): if ≥70% compliance and no Clavien-Dindo ≥III complications, the patients are included in the main analysis and enrollment continues.
• Decision B (Protocol Revision): if a systemic implementability barrier is identified, the first 5 patients are excluded from primary feasibility analysis, the protocol is revised to Version 2.0, ethics committee notification/approval is obtained, and the screening target is increased to N=105 to preserve statistical power. A pre-specified sensitivity analysis includes the original 5 patients in an "all-enrolled" set for transparency.

Audit and Feedback Compliance scorecard data are reviewed every 20 patients (h20, h40, h60, h80) by the leadership team. Compliance items are dichotomously coded (1=achieved, 0=not). Up to 3 items may be voided due to medical contraindication; ≥4 voided items classify the patient as "complex" and exclude them from the primary compliance analysis. Rescue analgesia use does NOT affect compliance scoring of the multimodal oral analgesia item but is reported as a secondary metric (total opioid consumption in mg/kg morphine equivalents).

Stopping Rules (3-tier) Level 1 (Immediate report): Any Clavien-Dindo ≥III complication is reported to the IRB within 24 hours as a Serious Adverse Event.

Level 2 (Temporary halt): Triggered by (a) any Grade IV/V complication, OR (b) cumulative Clavien-Dindo ≥III rate exceeding 10% in any consecutive 10-patient window, OR (c) unplanned true readmission rate exceeding 10% in any consecutive 10-patient window. Enrollment pauses; the leadership team holds an emergency safety meeting with at least one independent senior clinician (department chair or hospital quality/safety representative) as observer.

Level 3 (Permanent halt): If post-pause review concludes the complications are protocol-attributable, the study is permanently terminated and the IRB is notified with a detailed report.

Mixed Methods and Implementation Science The study uses a Concurrent Embedded mixed-methods design. Quantitative implementation outcomes (compliance, MRD time, length of stay, complications, opioid use) are integrated with provider surveys (KAP pre/post, CFIR Barriers, NoMAD post-pilot) and parent-reported outcomes (study-specific PROMs CRF: VAS for parental anxiety/satisfaction, categorical Yes/No items for quality of recovery). Qualitative content analysis of an open-ended PROMs question uses two-coder blinded review with Cohen's κ ≥0.70 threshold and third-coder consensus arbitration.

Statistical Analysis Sample size: precision-based, single-proportion formula yields n=80 evaluable patients to estimate compliance at 80% with a 95% CI half-width of ±8.7% (lower bound 71.3%, upper 88.7%) - verified in G*Power 3.1 ('Proportion: Confidence Interval Width' module). Allowing for ~20% cumulative attrition (10-15% intraoperative reclassification, 2-5% laparoscopic-to-open conversion, 3-5% follow-up loss), 100 patients are enrolled.

The primary endpoint compliance rate is reported as a point estimate with Wilson 95% CI. Co-primary safety endpoints (Clavien-Dindo ≥III, 30-day readmission) are similarly reported. Critical-item compliance is reported per item with 95% CIs. Survey modules: KAP pre vs post - Wilcoxon signed-rank if paired n ≥15, otherwise descriptive only; KAP/CFIR Cronbach α ≥0.70 threshold reported (gating); NoMAD α reported but non-gating. Subgroup analyses are exploratory/hypothesis-generating. Missing data: pre-specified multiple imputation thresholds. Reporting follows CONSORT-Pilot.

Anticipated Outcomes If feasibility is demonstrated (compliance ≥80% with CI lower bound >70%, safety endpoints below 5%), the protocol will be formalized as the institutional standard for non-complicated pediatric appendectomy and will inform a planned multi-center IDEAL Stage 3 trial. If feasibility is not demonstrated, the audit data will identify specific implementability barriers for targeted revision before any further deployment.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmet B DOĞAN, Associate Professor; Phone Number: +90 533 390 86 34; Email: drkarden@gmail.com
• Study Contact Backup: Name: Yasin Sipahi, Research Assistant; Phone Number: +90 507 119 00 58; Email: sipahiysn@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Kayseri
    • Kayseri, Kayseri, Turkey (Türkiye), 38039
      • Erciyes University Faculty of Medicine, Department of Pediatric Surgery
      • Contact: Yasin Sipahi, Research Assistant; Phone Number: +90 507 119 00 58; Email: sipahiysn@hotmail.com
      • Contact: Ahmet DOĞAN, Associate Professor; Phone Number: +90 533 390 86 34; Email: drkarden@gmail.com
      • Principal Investigator: Ahmet B DOĞAN, Associate Professor
      • Sub-Investigator: Yasin Sipahi, Research Assistant
      • Sub-Investigator: Karamehmet YILDIZ, Professor
      • Sub-Investigator: Sibel S PEHLİVAN, Associate Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pediatric patients aged 5 to 18 years (preschool, school-age, and adolescent).
2. Acute appendicitis without preoperative radiologic or clinical evidence of complication/perforation, who are candidates for and accept laparoscopic surgery.
3. ASA Physical Status I (healthy) or ASA II (mild systemic disease).
4. Family/legal guardians literate in Turkish (or the institution's primary service language) and able to comprehend the educational materials.
5. Written informed consent from parents/legal guardians; for children of sufficient developmental maturity (generally ≥7 years), age-appropriate written assent.

Exclusion Criteria:

1. Preoperative imaging or clinical evidence of complicated appendicitis (perforation, generalized peritonitis, intra-abdominal abscess) anticipated to require an extended procedure (anastomosis, resection, or extensive peritoneal irrigation).
2. History of chronic pain syndrome or regular/sustained opioid use within the past 3 months.
3. Therapeutic preoperative antibiotic treatment for an active infection (other than surgical prophylaxis).
4. ASA III or higher; immunosuppression, progressive neurological disease, chronic inflammatory bowel disease, or other significant comorbidities likely to interfere with postoperative recovery/mobilization.
5. Anatomic/mechanical contraindications to laparoscopy or pneumoperitoneum (e.g., prior major open abdominal surgery with suspected adhesions, abdominal wall defects).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ERAS Protocol Implementation Cohort; Children aged 5-18 with non-complicated acute appendicitis (ASA I-II) undergoing elective minimally invasive (laparoscopic) appendectomy who receive the comprehensive 20-item perioperative ERAS protocol as the institutional standard of care during the pilot period. The arm is single; there is no concurrent control group. Comparison anchors are pre-specified literature thresholds (≥70% compliance lower bound) and historical descriptive baseline data from the preceding 6 months at the same institution.

Other: Comprehensive 20-Item Pediatric ERAS Protocol; A multidisciplinary 20-item perioperative care pathway spanning preoperative (5 items: family education, fasting management with clear fluids permitted up to 2 hours preoperatively, no oral carbohydrate loading, no mechanical bowel preparation, restricted sedative premedication), intraoperative (9 items: timely prophylactic antibiotics within 30-60 min of incision, regional analgesia with 0.25% bupivacaine port-site infiltration, short-acting anesthetic agents, restricted intraoperative opioid <0.1 mg/kg morphine equivalent, active normothermia >36 °C, goal-directed euvolemic fluid therapy 3-7 mL/kg/h, minimally invasive surgical approach, avoidance of routine drains/tubes, universal PONV prophylaxis with ondansetron + dexamethasone 0.15 mg/kg max 8 mg), and postoperative (6 items: early NG tube removal, early oral feeding within 2-4 hours, early IV fluid discontinuation, early mobilization with corridor walk by hour 6, multimodal scheduled zigzag oral analgesia with paracetamol 15 mg/

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global ERAS Compliance Rate	Proportion of patients in the evaluable cohort (n≈80) achieving full compliance with at least 80% of the applicable 20 ERAS items (i.e., at least 16 of 20 items implemented as planned). Each of the 20 items is dichotomously coded (1 = achieved, 0 = not achieved). Up to 3 items may be voided per patient due to medical contraindication; patients with ≥4 voided items are classified as "complex" and excluded from the primary analysis. The compliance rate is reported as a point estimate with Wilson 95% confidence interval. The pre-specified success criterion is the lower bound of the 95% CI exceeding 70%.	Index hospitalization, from preoperative admission through actual discharge (typically ≤72 hours).
Postoperative Major Complication and Unplanned Readmission Rate (30-day)(Co-primary)	Composite of (a) Clavien-Dindo Grade III or higher major complications occurring within 30 days of surgery, AND (b) unplanned true inpatient readmission within 30 days of discharge. Each component is reported separately as a proportion with 95% CI. The pre-specified success criterion is each component remaining below 5%. Both feasibility (Primary Outcome 1) and this safety composite must be met for the protocol to be considered feasible-and-safe.	30 days postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Critical-Item Compliance Rate	Per-item compliance rate for each of 5 critical ERAS components: (i) multimodal analgesia, (ii) goal-directed perioperative fluid management, (iii) early oral feeding, (iv) minimally invasive surgical approach, (v) drain/tube restriction. Reported as proportions with 95% CIs. Each is targeted at >80%.	From surgery (Day 0) through hospital discharge, an average of 2 days
Time to Medical Readiness for Discharge (MRD)	Time from arrival at the post-anesthesia care unit (T0) to the time the patient meets all 6 MRD criteria, reported in hours. MRD criteria are: (i) tolerating at least Phase 2 diet without vomiting and without IV support (no vomiting in last 4 hours); (ii) pain controlled on oral analgesics alone with VAS or FLACC <4; (iii) age-appropriate unsupported ambulation; (iv) spontaneous urine output; (v) family preparedness for home care; (vi) physiologic stability and normothermia (room-air SpO2 >95% or baseline; temperature <38 °C in the last 4 hours; heart rate, blood pressure, respiratory rate within PALS 2020 limits ±10%).	From PACU arrival until MRD criteria met (typically ≤48 hours).
Actual Length of Hospital Stay	Time in hours from end of surgery to actual hospital discharge.	From end of surgery to actual hospital discharge, an average of 2 days
Delta Time (Institutional Discharge Delay Metric)	T-Discharge minus T-MRD, in hours - measures the institutional/cultural delay between objective medical readiness and actual discharge.	From objective medical readiness (T-MRD) to actual hospital discharge, an average of 1 day
Time to First Oral Tolerance (Water)	Time from end of surgery (T0) to successful oral water tolerance in hours.	From end of surgery (Day 0) to first successful oral water tolerance, an average of 4 hours
Time to First Unsupported Ambulation	Time from end of surgery (T0) to first unsupported ambulation in hours.	From end of surgery (Day 0) to first unsupported ambulation, an average of 8 hours
Time to First Age-Appropriate Normal Diet (Phase 3)	Time from end of surgery (T0) to first tolerated age-appropriate normal diet (≥150 mL or age-appropriate portion) in hours.	From end of surgery (Day 0) to first tolerated age-appropriate normal diet, an average of 24 hours.
Total Rescue Opioid Consumption (0-24 hours)	Total rescue opioid consumption between hour 0 and hour 24 postoperatively, normalized to milligram morphine equivalent dose (MED) per kilogram body weight (mg/kg).	First 24 hours postoperative.
Parent-Reported Outcomes (PROMs) - Anxiety, Satisfaction, Quality of Recovery	Three components measured via the study-specific "ERAS Family Experience and Clinical Monitoring Form" administered before actual discharge: (a) parental preoperative anxiety on a 0-10 visual analog scale (VAS); (b) parental postoperative satisfaction on a 0-10 VAS (target ≥8/10); (c) attainment rates of categorical (Yes/No) quality-of-recovery items including information adequacy, early oral tolerance, mobilization adequacy, and oral analgesia pain control. Reported as median (IQR) for VAS and proportions with 95% CIs for categorical items.	Pre-discharge (typically postoperative day 0-2).
Provider Knowledge-Attitudes-Practice (KAP) Change	Pre-pilot vs post-pilot KAP module score change among the multidisciplinary team (surgeons, anesthesiologists, OR/ward nurses). Wilcoxon signed-rank test if paired n ≥15; otherwise descriptive only.	Pre-pilot (before patient enrollment) and post-pilot (after final patient enrollment), approximately 12 months apart.
CFIR Barriers Assessment	CFIR 2.0-informed barriers/facilitators perception scores among the multidisciplinary team, administered pre-pilot.	Pre-pilot (before patient enrollment).
NoMAD Normalization Process Measure	NoMAD-TR (Turkish-validated) normalization measures of how the ERAS protocol becomes embedded in routine practice, administered post-pilot.	Post-pilot (within 1 month of last patient discharge).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance-Outcome Correlation (hypothesis-generating)	Spearman rank correlation between individual ERAS Compliance Score and (a) MRD time, (b) total rescue opioid use, (c) actual LOS. Reported as point estimate with 95% CI; pre-specified as exploratory/hypothesis-generating given the limited sample size.	Cumulative across 30-day follow-up.

Collaborators and Investigators

• Sponsor: Ahmet Burak Doğan, MD
• Investigators: Principal Investigator: Ahmet B DOĞAN, Associate Professor, Erciyes University, Faculty of Medicine, Department of Pediatric Surgery

Publications and helpful links

General Publications

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
• Finch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, McColl E, Steen IN, Cook C, Vernazza CR, Mackintosh N, Sharma S, Barbery G, Steele J, Rapley T. Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med Res Methodol. 2018 Nov 15;18(1):135. doi: 10.1186/s12874-018-0591-x.
• Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
• Singh N, Ahn J, Chen X, Park S, Singh S, Cardamone S, Davis R, Hsieh H, Moore RP. Improved Post-Operative Outcomes and Reduced Narcotic Use With ERAS Protocol in a Pediatric Ambulatory Surgery Setting. Paediatr Neonatal Pain. 2025 Mar 10;7(1):e70004. doi: 10.1002/pne2.70004. eCollection 2025 Mar.
• Selesner L, Gutierrez A, Vaughn C, Graveson A, Yoo A, Wooten A, Wilson R, Jafri M, Azarow K, Krishnaswami S, Fialkowski E. Standardized Perioperative Protocols and Variance in Pediatric Surgery. JAMA Surg. 2025 Oct 1;160(10):1108-1116. doi: 10.1001/jamasurg.2025.2927.
• Roberts K, Brindle M, McLuckie D. Enhanced recovery after surgery in paediatrics: a review of the literature. BJA Educ. 2020 Jul;20(7):235-241. doi: 10.1016/j.bjae.2020.03.004. Epub 2020 May 6. No abstract available.
• Strine AC, Chu DI, Brockel MA, Wilcox DT, Vricella GJ, Coplen DE, Traxel EJ, Chaudhry R, VanderBrink BA, Yerkes EB, Chan YY, Burjek NE, Zee RS, Herndon CDA, Ahn JJ, Merguerian PA, Meenakshi-Sundaram B, Rensing AJ, Frimberger D, Rove KO; PURSUE Study Group. Feasibility of Enhanced Recovery After Surgery (ERAS) implementation in Pediatric Urology: Pilot-phase outcomes of a prospective, multi-center study. J Pediatr Urol. 2024 Apr;20(2):256.e1-256.e11. doi: 10.1016/j.jpurol.2023.12.017. Epub 2023 Dec 30.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: ERU-PEDERAS-2026-263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the published results, the full study protocol, the statistical analysis plan, and the informed consent forms will be made available upon reasonable request following primary publication. Access will be granted to investigators with a methodologically sound proposal for individual participant data meta-analyses or hypothesis-confirming research. Requests will be reviewed by the principal investigator and the study steering committee. Data will be transferred via encrypted email or institutional secure repository following execution of a data sharing agreement.
• IPD Sharing Time Frame: Beginning 6 months and ending 5 years following primary publication.
• IPD Sharing Access Criteria: Investigators with a methodologically sound proposal for individual participant data meta-analyses or hypothesis-confirming research. Requests will be reviewed by the principal investigator and the study steering committee. Data will be transferred via encrypted email or institutional secure repository following execution of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No