An observational study in IBD (Inflammatory Bowel Disease), Hemorrhoid and Safety, sponsored by Treviso Regional Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Treviso Regional Hospital · Observational
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.
To date, there is no consensus in the scientific literature regarding the exact indications for surgery for hemorrhoidal disease (HD) in patients with inflammatory bowel disease (IBD). The HEAD-IBD-II study is a multicenter, prospective cohort designed to evaluate the safety and effectiveness of surgical treatments for hemorrhoidal disease (HD) in patients with inflammatory bowel disease (IBD). This study aims to collect contemporary, real-world data from multiple hospitals across various countries, focusing on the surgical management of HD in this unique patient population. The study will include adult patients with a confirmed diagnosis of Crohn's disease or ulcerative colitis who undergo surgery for HD.
The data collection process will involve detailed records of patient demographics, pre-operative status, operative techniques, and post-operative outcomes, with a specific focus on short-, medium-, and long-term surgical and clinical results. The study will track outcomes such as postoperative complications, recurrence of symptoms, IBD flare-ups, and anal continence.
In addition, factors such as surgical volume, techniques employed, and individual patient characteristics will be analyzed to identify variables that may impact the outcomes. The study is designed to generate hypotheses and explore variability in current practices, thereby highlighting areas in need of further investigation through randomized controlled trials.
All patient data will be collected anonymously through a secure electronic case report form (eCRF), and results will be disseminated according to the STROBE guidelines for observational studies. Ethical approval will be obtained from participating institutions, and all patients will provide informed consent prior to inclusion. The study is expected to improve the understanding of surgical approaches to HD in IBD patients and potentially guide future clinical recommendations.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 50 is below the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Treviso Regional Hospital is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who will undergo surgery for hemorrhoidal disease after the diagnosis of IBD will be enrolled in several centers across the European territory.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients with an established diagnosis of IBD who will undergo surgery for HD from January to December 2025 and followed-up for at least 1 year post-operatively will be prospectively included. Data on patient demographics and clinical characteristics, operative details and clinical outcomes will be collected.
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 surgery
No study locations are listed for this record.
Plan to share: No — The IPD will not be shared due to concerns related to patient confidentiality and the sensitive nature of the clinical data involved in this study. Although the data will be anonymized, the sharing of IPD may still pose risks regarding patient privacy. Furthermore, the study's results will be shared in aggregate form through peer-reviewed publications, ensuring transparency and dissemination of the findings without compromising individual data privacy.
Start is estimated for Jan 2025; primary completion for Dec 2026, 23 months later.
Of 243 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 132. This study's planned 23 months is below that.
Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Treviso Regional Hospital