Treatment of IBS in Primary Health Care.

NCT ID: NCT05144581

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2024-05-31

Brief Summary

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The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.

Detailed Description

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The defining features of IBS comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the Rome IV criteria. The spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. Despite the prevalence of IBS, its management remains a challenge for global healthcare systems.

Treatment of IBS comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. Pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics.

Since the majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (GPs) to recommended therapeutic approaches for IBS.

In this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in Örebro Region. Patients will be identified by ICD-code K.58. The used treatments will be categorized in grade of recommendation as well as in strength of evidence. The efficacy of the used treatments will be evaluated, if possible. Over the counter agents, and lifestyle adjustments will not be evaluated.

The used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). The eventual use of inappropriate treatments will be recorded as well. The efficacy of the used treatments will be, if possible, evaluated from the patient registers. The standardized and validated questionnaires IBS-Symptom Severity Score and IBS-Quality of Life scores are not routinely used within the primary health care. For this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect".

Descriptive statistics will be used.

Conditions

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Irritable Bowel Syndrome

Keywords

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Irritable bowel syndrome Functional gastrointestinal disorders

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients diagnosed with IBS

Patients diagnosed with IBS within primary care in Region Örebro County 2013-2017, identified by ICD-code K.58.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2013-2017.

Exclusion Criteria

* Patients \< 18 years or \> 65 years.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michiel van Nieuwenhoven, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Region Örebro County

Central Contacts

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Jussi Rauma, M.D.

Role: CONTACT

Phone: +460702484167

Email: [email protected]

Other Identifiers

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277071

Identifier Type: -

Identifier Source: org_study_id