Anorectal Manometry of Patients With Constipation Predominant IBS

Not yet recruiting

• Conditions: Constipation-predominant Irritable Bowel Syndrome

• Registration Number: NCT05921383
• Lead Sponsor: Assiut University

Brief 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

Detailed 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

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-18
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Study Start: 2023-07-01
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Value of manometry for diagnosis of functional constipation	1years	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