Inflammatory Bowel Diseases, Surgery
Conditions
Keywords
Inflammatory Bowel Disease, Surgery, Anxiety and Depression
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.
Interventions
DEVICEHowdy Senior® device
Standard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-center, interventional, case-series study with a historical cohort of comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV) | From 14 days to 1 day before surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S) | From 14 days to 1 day before 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 preoperative Patient Health Engagement Scale (PHE-S, self-reporting scale ranging from 0 (complete disease awareness) to 12 (complete absence of disease awareness). |
| Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery | 24 hours 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. |
| Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI) | 90 days after surgery | 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 |
| Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV) | 90 days after surgery | 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. |
| Healthcare costs | 6 months after surgery | Median difference of the healthcare resources used in the interventional cohort and the historical cohort of comparison. |
| 90-day postoperative complications | 90 days after surgery | Rate difference of 90-day postoperative complications (classified according to the Clavien-Dindo scale) between the interventional cohort and the historical cohort of comparison. |
Countries
Italy
Contacts
Primary ContactAnnalisa Maroli, PhD
Outcome results
None listed