NCT06299423

Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Surgery

Interventions

Type	Name	Description
DEVICE	Howdy Senior® device	Standard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments.

Timeline

• Start date: 2023-11-22
• Primary completion: 2025-06-30
• Completion: 2025-11-30
• First posted: 2024-03-07
• Last updated: 2024-03-08

Locations

1 site across 1 country: Italy