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
Istituto Clinico Humanitas
80 participants
Nov 22, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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.
Interventions
Standard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06299423