Clinical trial NCT05488041: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Meir Medical Center
name: Nazareth Hospital
First posted: 2022-08-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Defecation disorders in patients with UC
timeFrame: Two years
Secondary outcomes:
measure: To examine a possible correlation between the findings in anal manometry and other disease parameters, clinical, laboratory, and histological characteristics.
timeFrame: Two years
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
Study officials:
affiliation: Shamir (Assaf-Harofeh MC)
name: Vered Richter, Dr
role: PRINCIPAL_INVESTIGATOR
References: