MIND-IBD: Psychological Predictors in Colorectal IBD Surgery Recovery

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03893942

Collaborator

(none)

Enrollment

Location

23.5

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Other: Questionnaires administration Other: Langer Mindfulness Scale (LMS) Other: Mindful Attention Awareness Scale (MAAS) Other: Cognitive Flexibility Scale (CFS) Other: Life Orientation Test (LOT) Other: Mini Locus of Control test (MLS) Other: Hospital Anxiety and Depression Scale (HADS) Other: Perceived Stress Scale (PSS)

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Psychological Predictors of Post-surgical Recovery in Inflammatory Bowel Disease: a Pilot Cohort Study

Actual Study Start Date :

Apr 16, 2019

Actual Primary Completion Date :

Oct 25, 2020

Anticipated Study Completion Date :

Apr 1, 2021

Outcome Measures

Primary Outcome Measures

Correlation between psychological predictors questionnaires outcome and length of hospital stay [Post-operative day 7]
Length of stay calculated in days from the day of surgery until the day of discharge
Correlation between psychological predictors questionnaires outcome and quality of life [Post-operative day 30]
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)
Correlation between psychological predictors questionnaires outcome and quality of life [Post-operative day 90]
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)
Correlation between psychological predictors questionnaires outcome and quality of life [Post-operative month 6]
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)
Correlation between psychological predictors questionnaires outcome and quality of life [Post-operative month 12]
Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)