Anorectal Manometry of Patients With Constipation Predominant IBS

NCT ID: NCT05921383

Last Updated: 2023-06-27

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

NOT_YET_RECRUITING

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

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The aim of The study is to compare between the anorectal manometric profile of patients with functional constipation and patients with constipation predominant irritabe bowel syndrome

Detailed Description

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Chronic constipation (CC) is a common medical problem throughout the world \[1-3\] The global prevalence of CC in the community varies from 11% to 18% \[4\].

In patients presenting to tertiary care facilities, specific pathophysiological abnormalities like defecatory disorder and slow colonic transit contribute to CC.

CC has a significant burden on the utilization of healthcare resources, including the cost of inpatient and outpatient care, laboratory tests, and diagnostic procedures \[5, 6\].

CC is characterized by difficulty in passing stools or a low frequency of bowel movements, often accompanied by straining during defecation or a feeling of incomplete evacuation \[7, 8\].

For western population, CC is defined by Bristol stool form (BSF) I-II, while in Indian patients, addition of type III Bristol stool form increases diagnostic sensitivity \[2\]. In the ROME IV criteria, it has been suggested that all patients with CC without evidence of structural or metabolic abnormalities to explain symptoms should be considered under the umbrella of functional constipation (FC) \[8\].

FC is defined as the presence of two or more of the followings during the previous 3 months:

1. Defecatory straining (\> 25% of bowel movements)
2. Hard or lumpy stools (\> 25% of bowel movements)
3. Feeling of incomplete evacuation (\> 25% of bowel movements)
4. Defecatory obstruction (\> 25% of bowel movements)
5. Manual maneuvers to facilitate defecation (\> 25% of bowel movements)
6. Fewer than three spontaneous complete bowel movements per week. Symptoms must be present for at least 6 months before the diagnosis, and diarrhea must not be present except after using a laxative \[8\].

Patients with FC should not meet irritable bowel syndrome (IBS) criteria, although bloating may be present. In contrast, patients with irritable bowel syndrome with constipation (IBS-C) have abdominal pain as the predominant symptom along with Bristol stool form types 1 or 2 more than 25% of the times. \[8\].

Among patients presenting with CC, Indian studies have reported FC to be commoner than IBS-C \[9, 10-12\].

High-resolution (HR-) anorectal manometry has significant diagnostic value in the assessment of anorectal disorders \[13\] This study aimed to compare the clinical and anorectal manometry profile of patients with FC and constipation-predominant irritable bowel syndrome

Conditions

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Constipation-predominant Irritable Bowel Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age between 18- 60 years old .
2. Patients fulfill ROME IV criteria of chronic constipation.

Exclusion Criteria

* Patient with secondary causes of constipation :-

1. Thyroid disease
2. Acute or chronic kidney disease
3. Acute or Chronic Liver Disease.
4. Malignancy 5 -Medication 6 -Uncontrolled diabetes mellitus 7 -Inflammatory bowel diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Heba Sayed Zaki Bebe

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015 Mar 3;313(9):949-58. doi: 10.1001/jama.2015.0954.

Reference Type RESULT
PMID: 25734736 (View on PubMed)

Related Links

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Other Identifiers

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Anorectal manometery

Identifier Type: -

Identifier Source: org_study_id

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