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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05921383
Other study ID # Anorectal manometery
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date December 2025

Study information

Verified date June 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 102
Est. completion date December 2025
Est. primary completion date November 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Value of manometry for diagnosis of functional constipation 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 1years
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