Anorectal Manometry of Patients With Constipation Predominant IBS

Anorectal Manometry of Patients With Constipation Predominant Irritable Bowel Syndrome

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

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation-predominant Irritable 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 Type: Observational
• Enrollment (Estimated): 102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

both males and females between age 18-60 years

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: June 18, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation
• Other Study ID Numbers: Anorectal manometery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No