Psychological Predictors in Colorectal IBD Surgery Recovery (MIND-IBD)

Istituto Clinico Humanitas

Status: Unknown

Conditions: Inflammatory Bowel Diseases

Treatments: Other: Cognitive Flexibility Scale (CFS); Other: Mini Locus of Control test (MLS); Other: Life Orientation Test (LOT); Other: Mindful Attention Awareness Scale (MAAS); Other: Hospital Anxiety and Depression Scale (HADS); Other: Langer Mindfulness Scale (LMS); Other: Perceived Stress Scale (PSS); Other: Questionnaires administration

Study type: Observational

Funder types: Other

Identifiers

NCT03893942

2214

Details and patient eligibility

About

This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal surgery for Inflammatory Bowel Diseases (IBD), including Crohn's disease and Ulcerative Colitis.

Full description

The chronic nature of Inflammatory Bowel Disease (IBD) leads to a significant impact on patients' lives, beyond intestinal symptoms alone. The sequelae of this can be seen in the increased rates of depression and reduced quality of life (QoL). Surgery may provide a way to effectively induce long-term symptoms remission, although there is a short postoperative transitory period whereas quality of life might decrease. Over the last years, increasing interest has been gained by perioperative recovery protocols, aiming to accelerate functional recovery and to reduce complications. Some of these protocols include an in-depth discussion with both dedicated nurses and/or surgeons to decrease surgery-associated stress reaction. Nevertheless, no one of the proposed protocols has included a psychological assessment in order to correlate it with functional recovery. We suggest that studying the psychological characteristics of the patients (with a specific focus on mindfulness) could lead to open a new research front to optimize patients' outcomes.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 18 years old (both males and females).
• Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis).
• Patients scheduled for elective open or laparoscopic surgery for curative intent.

Exclusion criteria

• Patients unable to give the written informed consent.
• Patients < 18 years old.
• Patients undergoing surgery in emergency setting.
• Patients with pre-operative evidence of colorectal cancer or High Grade/Low grade dysplasia.
• Pregnant or breastfeeding patients.
• Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia)