Anal Manometry Examination in Patients With Ulcerative Colitis

• ClinicalTrials.gov Identifier: NCT05488041
• Recruitment Status: Recruiting
• First Posted: August 4, 2022
• Last Update Posted: August 4, 2022
• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Meir Medical Center; Nazareth Hospital
• Information provided by (Responsible Party): Vered Richter, Assaf-Harofeh Medical Center

Tracking Information

• First Submitted Date: November 16, 2021
• First Posted Date: August 4, 2022
• Last Update Posted Date: August 4, 2022
• Actual Study Start Date: June 1, 2022
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2022)

Defecation disorders in patients with UC [ Time Frame: Two years ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 3, 2022)

To examine a possible correlation between the findings in anal manometry and other disease parameters, clinical, laboratory, and histological characteristics. [ Time Frame: Two years ]

The investigators will examine a possible correlation between defecation disorders in patients with UC in remission to the following parameters: disease characteristics: disease extension, presence of stenosis, presence of anal fissure or hemorrhoids, levels of CRP and calprotectin, presence of extra-intestinal manifestations; to symptoms such as the number of defecations per day, the texture of stool according to Bristol, exertion effort, feeling of emptiness, tenesmus, use of laxatives / anti-diarrhea medication, use of leakage pads; to findings in biopsies taken from the last colonoscopy/sigmoidoscopy. A comparison will be made to a control group of UC patients in remission without anorectal symptoms, as well as to the normal values in the literature

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Anal Manometry Examination in Patients With Ulcerative Colitis
• Official Title: Characteristics of Anal Manometry Examination in Patients With Ulcerative Colitis (UC) in Remission With Anorectal Symptoms in a New Disease Compared to a Disease of Many Years

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.

Detailed Description

The study will include patients with ulcerative colitis in clinical, laboratory, and endoscopic remission, and with one of the following symptoms: Urgency, fecal incontinence, incontinence to gas, tenesmus, rectal discomfort, rectal pain, excessive straining and incomplete evacuation.

Patients that will not be included: patients after ileal pouch-anal anastomosis (IPAA), and patients with colonic stenosis that could not be passed with an endoscope.

Patients will undergo an anorectal manometry test and the results will be compared to a control group that will include patients with ulcerative colitis in remission without anorectal complaints, as well as to the normal values in the literature.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Ulcerative Colitis

Intervention

Procedure: Performing anorectal manometry

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.

Study Arms

• Experimental: UC patients with anorectal symptoms
  Patients with ulcerative colitis in remission who have anorectal symptoms will undergo an anal manometry test to characterize these symptoms.
  Intervention: Procedure: Performing anorectal manometry
• Active Comparator: UC patients without anorectal symptoms
  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
  Intervention: Procedure: Performing anorectal manometry

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2022): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Vered ר Richter, Dr; 972-50-5191976; richterv@gmail.com

Contact: Efrat Broide, Prof; 972-54-4819077; efibroide@yahoo.com

• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT05488041
• Other Study ID Numbers: 0232-21-ASF
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: All patient data will be securely stored at the medical center

• Current Responsible Party: Vered Richter, Assaf-Harofeh Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Assaf-Harofeh Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Meir Medical Center
• Nazareth Hospital

Investigators

• Principal Investigator: Vered Richter, Dr; Shamir (Assaf-Harofeh MC)

• PRS Account: Assaf-Harofeh Medical Center
• Verification Date: August 2022