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

Istituto Clinico Humanitas

Status: Enrolling

Conditions: Surgery; Inflammatory Bowel Diseases

Treatments: Device: Howdy Senior® device

Study type: Interventional

Funder types: Other

Identifiers

NCT06299423

3677

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Howdy Senior® device

Experimental group

Description:

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.

Treatment:

Device: Howdy Senior® device

Standard perioperative management

No Intervention group

Description:

Patients belonging to the historical cohort of comparison, who underwent standard perioperative management and surgical intervention between January 2021 and January 2022.