Psychological Predictors in Colorectal IBD Surgery Recovery

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT03893942
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Study Start: 2019-04-16
• Primary Completion: 2020-10-25
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 month 12	Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)

Trial Locations

Locations (1)

IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery; 🇮🇹 Rozzano, MI, Italy