Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients (PeRseo)

Perioperative Electrocardiogram Remote Monitoring to Assess Preoperative Psychological Distress and Improve Postoperative Recovery in Inflammatory Bowel Disease Surgery: a Pilot Single-arm Prospective Study

Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Surgery
• Intervention / Treatment: Device: Howdy Senior® device

Detailed Description

Inflammatory Bowel Disease (IBD) patients are at high risk of postoperative complications and delayed recovery. Preoperative anxiety and low patient's awareness of the disease may increase the risk of postoperative complications inducing an autonomic impairment which may in turn determine an inflammatory unbalance. This correlation can be confirmed through the preoperative monitoring of the autonomic function- with wearable electrocardiogram (ECG) devices. The Howdy Senior® device (ComfTech Srl) allows the real-time remote ECG monitoring and the computation of stress and fatigue indexes.

The Howdy Senior® device may also provide a reliable tool for remotely monitoring the patient's clinical parameters after discharge.

This study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the Howdy Senior® device for the postoperative patients' remote monitoring.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • Irccs Humanitas Research Hospital
      • Contact: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients aged more than 18 years old.
• Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis.
• Patients scheduled for elective intestinal resection.

Exclusion Criteria:

• Diagnosis of Undetermined Colitis.
• Recurrent disease.
• Concomitant diagnosis of malignancy.
• Established diagnosis of major depressive disorder or anxiety disorder.
• Diagnosis of ventricular or supraventricular arrythmia.
• Active pharmacological treatment with β-blockers or other drugs affecting the heart rate.
• Known hypersensitivity to cotton or silver.
• Emergent surgery.
• Planned open surgery.
• Any concomitant surgery unrelated to the main surgical indication. Patients undergoing perianal surgery for related perianal disease can be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Howdy Senior® device; Patients will undergo standard perioperative management. Additionally, patients will perform three preoperative and twelve postoperative HOWDY Senior® assessments. The assessment consists of a nocturnal electrocardiogram (ECG) measure and a morning rest Heart Rate Variability (HRV) measure of five minutes.	Device: Howdy Senior® device; Standard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments.
No Intervention: Standard perioperative management; Patients belonging to the historical cohort of comparison, who underwent standard perioperative management and surgical intervention between January 2021 and January 2022.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV)	Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reporting scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the median value of at least three Heart Rate Variability (HRV) measures collected in the preoperative period through the Howdy Senior® device.	From 14 days to 1 day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI)	Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reporting scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the median value of the Comprehensive Complication Index (CCI) (Index ranging from 0 (no complication) to 100 (death)) at 90 days after the surgical intervention	90 days after surgery
Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery	Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reported scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the level of serum C-Reactive Protein (CRP, µg/mL) measured 24 hours after surgery.	24 hours after surgery
90-day postoperative complications	Rate difference of 90-day postoperative complications (classified according to the Clavien-Dindo scale) between the interventional cohort and the historical cohort of comparison.	90 days after surgery
Healthcare costs	Median difference of the healthcare resources used in the interventional cohort and the historical cohort of comparison.	6 months after surgery
Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S)	Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reported scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the preoperative Patient Health Engagement Scale (PHE-S, self-reporting scale ranging from 0 (complete disease awareness) to 12 (complete absence of disease awareness).	From 14 days to 1 day before surgery
Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV)	Correlation between the 90-day Postoperative Recovery Profile (PRP) (Scale ranging from 0 (completely recovered) to 68 (not recovered)) and the median value of at least twelve Heart Rate Variability (HRV) measures collected in the postoperative period through the Howdy Senior® device.	90 days after surgery

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Antonino Spinelli, MD, PhD, IRCCS Huamanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Inflammatory Bowel Disease; Anxiety and Depression
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 3677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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