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

February 2, 2021 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Rozzano, MI, Italy, 20089
        • IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Actual)

October 25, 2020

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2214 (Other Identifier: University of California, Irvine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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