Clinical trial NCT05921383: Anorectal Manometry of Patients With Constipation Predominant IBS
Official title: Anorectal Manometry of Patients With Constipation Predominant Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Constipation-predominant Irritable Bowel Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: both males and females between age 18-60 years

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

Eligibility criteria: 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

Primary outcomes:
measure: Value of manometry for diagnosis of functional constipation
timeFrame: 1years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.