Anal Manometry Examination in Patients With Ulcerative Colitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05488041
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assaf-Harofeh Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vered Richter, Dr
Principal Investigator Affiliation Shamir (Assaf-Harofeh MC)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

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.

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

Interventions

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.

Contact a Trial Team

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International Sites

Shamir Medical Center (Assaf Harofeh), Zerifin, Israel

Status

Recruiting

Address

Shamir Medical Center (Assaf Harofeh)

Zerifin, ,

Site Contact

Vered Richter

richterv@gmail.com

050-519-1976

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