Anal Manometry Examination in Patients With Ulcerative Colitis

NCT05488041 | Unknown

• 1 other identifier: 0232-21-ASF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune-related diseases. IBD symptoms frequently overlap with symptoms of functional GI disorders such as irritable bowel syndrome (IBS) and defecatory disorders, and these symptoms are common in patients with active disease, and also in quiescent disease. Underdiagnosis of abnormal anorectal function may result in an inappropriate escalation of IBD therapy. In this study, the investigators aim to evaluate if damage from chronic inflammation in UC results in anorectal damage such as hypersensitive, hyperactive, poorly compliant rectum, and hypotensive sphincter. If this is the case, early aggressive treatment of the disease is needed. Another important point in this study is to find out which of the anorectal symptoms are due to a hypersensitive, hyperactive, and poorly compliant rectum and not due to mucosal inflammation. The diagnosis of abnormal anorectal function via manometry may help to give the appropriate treatment, such as biofeedback or pharmacological treatment such as loperamide or tricyclic anti-depressants. This may avoid escalation or replacing effective IBD therapy unnecessarily.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Defecation disorders in patients with UC

  To evaluate the rate and types of defecation disorders in patients with UC in remission as examined by anorectal manometry (ARM), and to examine the correlation between these anorectal pathologies and disease duration in years.

  Two years

Secondary Outcomes (1)

• To examine a possible correlation between the findings in anal manometry and other disease parameters, clinical, laboratory, and histological characteristics.

  Two years

Study Arms (2)

UC patients with anorectal symptoms

EXPERIMENTAL

Patients with ulcerative colitis in remission who have anorectal symptoms will undergo an anal manometry test to characterize these symptoms.

Procedure: Performing anorectal manometry

UC patients without anorectal symptoms

ACTIVE COMPARATOR

Patients with ulcerative colitis in remission without anorectal symptoms will undergo an anal manometry test to characterize their anorectal function and to compare to those with symptoms

Procedure: Performing anorectal manometry

Interventions

Performing anorectal manometry PROCEDURE

Anorectal manometry is a safe, low-risk procedure and is unlikely to cause any pain, colorectal perforation is very rare. Seven cases have been published in four reports. * Anorectal Manometry - NY Gastroenterology Associates n.d. https://www.gastroenterologistnewyork.com/preparing-for-procedure/anorectal-manometry/ (accessed July 14, 2021). * Bionda M, Lenglinger J, … AH-J of E, 2020 undefined. Closure of Large Rectal Iatrogenic Perforation by Endoscopic Suture Device: Go for it. BorisUnibeCh 2020;01:13-5. https://doi.org/10.48350/151165.

UC patients with anorectal symptoms; UC patients without anorectal symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with UC in our clinics who have one of the following symptoms: Urgency, fecal incontinence, incontinence to gas, tenesmus, rectal discomfort, rectal pain, excessive straining, and incomplete evacuation
• A patient who has had a recent colonoscopy/sigmoidoscopy with endoscopic remission defined as Mayo endoscopic score ≤1

You may not qualify if:

• Patient after ileal pouch-anal anastomosis surgery (IPAA)
• Patients with colonic stenosis that did not allow endoscopic passage and did not undergo an endoscopic evaluation prior to the study

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Meir Medical Center: collaborator
• Nazareth Hospital: collaborator

Study Sites (1)

Shamir Medical Center (Assaf Harofeh)

Ẕerifin, Israel

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Vered Richter, Dr

  Shamir (Assaf-Harofeh MC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vered ר Richter, Dr

CONTACT

972-50-5191976; richterv@gmail.com

Efrat Broide, Prof

CONTACT

972-54-4819077; efibroide@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: August 4, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)