Clinical trial NCT06299423: Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients
Official title: Perioperative Electrocardiogram Remote Monitoring to Assess Preoperative Psychological Distress and Improve Postoperative Recovery in Inflammatory Bowel Disease Surgery: a Pilot Single-arm Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Surgery
Keywords: Inflammatory Bowel Disease
Surgery
Anxiety and Depression
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single-center, interventional, case-series study with a historical cohort of comparison
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV)
timeFrame: From 14 days to 1 day before surgery
Secondary outcomes:
measure: Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI)
timeFrame: 90 days after surgery
measure: Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S)
timeFrame: From 14 days to 1 day before surgery
measure: Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery
timeFrame: 24 hours after surgery
measure: 90-day postoperative complications
timeFrame: 90 days after surgery
measure: Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV)
timeFrame: 90 days after surgery
measure: Healthcare costs
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
Study officials:
affiliation: IRCCS Huamanitas Research Hospital
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: