Psychological Predictors in Colorectal IBD Surgery Recovery

NCT03893942 | Unknown

• 1 other identifier: 2214
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Diseases; Mindfulness; Psychological predictors; Colorectal surgery

Outcome Measures

Primary Outcomes (5)

• Correlation between psychological predictors questionnaires outcome and length of hospital stay

  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

  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

  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

  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

  Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S\_IBDQOL)

  Post-operative month 12

Interventions

Questionnaires administration OTHER

Psychological and quality of life questionnaires

Langer Mindfulness Scale (LMS) OTHER

The LMS is a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.

Mindful Attention Awareness Scale (MAAS) OTHER

The MAAS is a 15-item questionnaire, designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present

Cognitive Flexibility Scale (CFS) OTHER

The CFS is 12-item self-report test assessing awareness.

Life Orientation Test (LOT) OTHER

The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.

Mini Locus of Control test (MLS) OTHER

The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.

Hospital Anxiety and Depression Scale (HADS) OTHER

The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology

Perceived Stress Scale (PSS) OTHER

The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Istituto Clinico Humanitas, Division of Colon and Rectal Surgery

Rozzano, MI, 20089, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone; Perceived Stress Scale

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Antonino Spinelli, MD, PhD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: April 16, 2019
• Primary Completion: October 25, 2020
• Study Completion: April 1, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)