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
