Anal Manometry Examination in Patients With Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT05488041 |
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Recruitment Status :
Recruiting
First Posted : August 4, 2022
Last Update Posted : August 4, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis | Procedure: Performing anorectal manometry | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | June 1, 2022 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
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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
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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.
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- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05488041
| Contact: Vered ר Richter, Dr | 972-50-5191976 | richterv@gmail.com | |
| Contact: Efrat Broide, Prof | 972-54-4819077 | efibroide@yahoo.com |
| Israel | |
| Shamir Medical Center (Assaf Harofeh) | Recruiting |
| Zerifin, Israel | |
| Contact: Vered Richter 050-519-1976 richterv@gmail.com | |
| Principal Investigator: | Vered Richter, Dr | Shamir (Assaf-Harofeh MC) |
| Responsible Party: | Vered Richter, Principal Investigator, Assaf-Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT05488041 |
| Other Study ID Numbers: |
0232-21-ASF |
| First Posted: | August 4, 2022 Key Record Dates |
| Last Update Posted: | August 4, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | All patient data will be securely stored at the medical center |
| 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 |
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |