Factors Affecting Dissatisfaction to Treatments in Patients With Chronic Constipation and IBS With Constipation

NCT02813616 | Completed

• 1 other identifier: SC-2016
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic constipation (CC) and Irritable Bowel Syndrome with Constipation (IBS-C) are two conditions difficult to manage because factors affecting dissatisfaction to treatments are misleading. This observational multicentric national study is aimed to assess which factors are related with a clinically significant improvement in patients with CC and IBS-C. Patients will be evaluated at baseline and after every one-month "standard of care" therapy with standardised questionnaires to assess bowel habit and satisfaction to treatments. Somatisation, quality of life, colonic transit time and resting anal pressure will be assessed at baseline.

Conditions

Constipation; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of patients achieving a sustained improvement

  Sustained improvement is defined as a satisfaction score \> 4 on a 7 point visual analogue scale for 2 consecutive months with the same treatment regimen.

  2 months

Secondary Outcomes (10)

• Factors associated with sustained improvement: Gender

  2 months

• Factors associated with sustained improvement: Age

  2 months

• Factors associated with sustained improvement; Somatisation score

  2 months

• Factors associated with sustained improvement: Quality of life

  2 months

• Factors associated with sustained improvement: Anal resting pressure

  2 months

Other Outcomes (1)

• Agreement between M-PAC-Sym and Satisfaction Score

  1 month

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatients reffering to a third level center

You may qualify if:

• All patients aged 18 - 80 years old with IBS-C and CC. The diagnosis of CC and IBS-C will be defined according to Rome III criteria.

You may not qualify if:

• Patients with secondary causes of CC
• Pregnancy

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20148, Italy

Location

Related Publications (1)

• Basilisco G; Italian Society of Neurogastroenterology Motility (SINGEM) Study Group. Patient dissatisfaction with medical therapy for chronic constipation or irritable bowel syndrome with constipation: analysis of N-of-1 prospective trials in 81 patients. Aliment Pharmacol Ther. 2020 Mar;51(6):629-636. doi: 10.1111/apt.15657. Epub 2020 Feb 12.

  PMID: 32048753 DERIVED

MeSH Terms

Conditions

Constipation; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Guido Basilisco

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 27, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)