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Clinical Trials/CTRI/2025/01/079568
CTRI/2025/01/079568Not yet recruitingNot Applicable

Study Of Anorectal Manometry Profile Of Patients With Functional Constipation Or Constipation Predominant Irritable Bowel Syndrome In A Tertiary Care Center Of Eastern India

IPGMER and SSKM Hospital1 site in 1 country100 target enrollmentStarted: February 7, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Differences in anorectal manometry parameters between functional constipation and constipation predominant irritable bowel syndrome group.

Study Overview

Brief Summary

Purpose of the study to evaluate the anorectal manometry profile of patients with functional constipation or constipation predominant irritable bowel syndrome. Initially basic details will be taken, question related to onset of symptoms, progression of symptoms and other relevant questions on present, past and personal details will be asked. Those who will fulfill inclusion criteria will be included in study. Subjects will be asked about their blood test reports and radiological investigations. Subject will undergo digital rectal examination, ultrasound of whole abdomen, colonoscopy/ sigmoidoscopy and anorectal manometry. After that difference in anorectal manometry between functional constipation and constipation predominant irritable bowel syndrome will be evaluated.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient of either gender and age group above 18 years and less than 65 years, chronic constipation of more than 6-month duration defined according to ROME IV criteria (with Bristol stool form I to III) and fulfilling the ROME IV criteria of Functional constipation or constipation-predominant irritable bowel syndrome.
  • 2.Normal sigmoidoscopy/colonoscopy.

Exclusion Criteria

  • Patients having Constipation due to secondary causes like mechanical obstruction and drugs.
  • Patients having diabetes mellitus (HbA1c more than 7.5) Patients having thyroid disease (TSH value more than 7) Patients having decompensate liver disease.
  • Patients having Stage 3 and above Chronic kidney disease Patients having history of abdominal surgery except cholecystectomy and appendectomy Patients having history of Gynecological surgery Patients not giving consent.

Outcomes

Primary Outcomes

Differences in anorectal manometry parameters between functional constipation and constipation predominant irritable bowel syndrome group.

Time Frame: At end of study

Secondary Outcomes

  • Proportion of patients with dyssynergia.

Investigators

Sponsor
IPGMER and SSKM Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Probal Saha

IPGMER AND SSKMH

Study Sites (1)

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