HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study
Observational · No treatment assigned · Sites not listed yet · Treviso Regional Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD (Inflammatory Bowel Disease), Hemorrhoid and Safety. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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).
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2025-01-01 (planned).
- Main results expected around 2026-12-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Safety and effectiveness of surgical treatments for hemorrhoidal disease (12 months from surgery)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD (Inflammatory Bowel Disease); Hemorrhoid; Safety; Sugery; Surgery Related Complications Rate |
| Lead sponsor | Treviso Regional Hospital |
| Enrollment | 50 (estimated) |
| Start date | 2025-01-01 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2024-10-15 |
| Last updated | 2024-10-15 |
| Official title | HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study |
| ClinicalTrials.gov ID | NCT06638814 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.