Clinical trial NCT06638814: HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study
Official title: HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: IBD (Inflammatory Bowel Disease)
Hemorrhoid
Safety
Sugery
Surgery Related Complications Rate
Keywords: HEAD-IBD-II
Hemorrhoidal disease
IBD
Surgery
Lead sponsor: Treviso Regional Hospital
Sponsor class: NETWORK
First posted: 2024-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo surgery for hemorrhoidal disease after the diagnosis of IBD will be enrolled in several centers across the European territory.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and effectiveness of surgical treatments for hemorrhoidal disease
timeFrame: 12 months from surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Grossi U, Gallo G, Di Tanna GL, Bracale U, Ballo M, Galasso E, Kazemi Nava A, Zucchella M, Cinetto F, Rattazzi M, Felice C, Zanus G. Surgical Management of Hemorrhoidal Disease in Inflammatory Bowel Disease: A Systematic Review with Proportional Meta-Analysis. J Clin Med. 2022 Jan 28;11(3):709. doi: 10.3390/jcm11030709.