Anal Manometry Examination in Patients With Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Performing anorectal manometry

Intervention Type 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 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

Group Type ACTIVE_COMPARATOR

Performing anorectal manometry

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No