HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTreviso Regional Hospital
About this trial
Patients who will undergo surgery for HD after the diagnosis of IBD over a 12-month period will be enrolled across Europe.
Primary objective of this study is to determine the safety and effectiveness of surgical treatments for HD in a large multicenter cohort of IBD patients.
Secondary aim is to identify factors that may affect clinical and surgical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age of 18 years and above;
established diagnosis of Crohn's disease or ulcerative colitis at the time of surgery for hemorrhoidal disease;
planned surgery for hemorrhoidal disease during the study period, including hemorrhoidectomy (open, close or submucosal), transanal hemorrhoidal dearterialization, hemorrhoidal laser procedure, stapled hemorrhoidopexy).
Disqualifiers
previous surgery for hemorrhoidal disease other than office-based treatments (e.g., sclerotherapy injection, rubber band ligation);
active perianal disease at the time of surgical intervention.
Trial population
Patients who will undergo surgery for hemorrhoidal disease after the diagnosis of IBD will be enrolled in several centers across the European territory.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Patients who will undergo surgery for hemorrhoidal disease after the diagnosis of IBD
Trial outcomes
Primary outcomes
1
Safety and effectiveness of surgical treatments for hemorrhoidal disease
Data on patient demographics and clinical characteristics, operative details, and clinical and surgical outcomes will be collected. The surgical outcomes will include: length of hospital stay, 30-day readmission, and post-operative complications at medium- (6 months) and long-term (12 months) follow-up. The clinical outcomes will include: IBD flare, defined according to standard scores (i.e., partial Mayo score for ulcerative colitis and Harvey-Bradshaw Index for Crohn's disease) and need for therapeutic change or dose escalation during the 6 months after surgery, new onset of perianal disease, anal continence status at last follow-up.
Time frame
12 months from surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: