Clinical trial NCT03893942: Psychological Predictors in Colorectal IBD Surgery Recovery
Official title: Psychological Predictors of Post-surgical Recovery in Inflammatory Bowel Disease: a Pilot Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammatory Bowel Diseases
Mindfulness
Psychological predictors
Colorectal surgery
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) scheduled for elective curative colorectal surgery.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Correlation between psychological predictors questionnaires outcome and length of hospital stay
timeFrame: Post-operative day 7
measure: Correlation between psychological predictors questionnaires outcome and quality of life
timeFrame: Post-operative day 30
measure: Correlation between psychological predictors questionnaires outcome and quality of life
timeFrame: Post-operative day 90
measure: Correlation between psychological predictors questionnaires outcome and quality of life
timeFrame: Post-operative month 6
measure: Correlation between psychological predictors questionnaires outcome and quality of life
timeFrame: Post-operative month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: