HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study

NCT06638814 | Not Yet Recruiting

• 1 other identifier: HEAD-IBD-II
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IBD (Inflammatory Bowel Disease); Hemorrhoid; Safety; Sugery; Surgery Related Complications Rate

Keywords

HEAD-IBD-II; Hemorrhoidal disease; IBD; Surgery

Outcome Measures

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.

  12 months from surgery

Study Arms (1)

Patients who will undergo surgery for hemorrhoidal disease after the diagnosis of IBD

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Treviso Regional Hospital: lead

Related Publications (1)

• 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.

  PMID: 35160159 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Hemorrhoids

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Rectal Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ugo Grossi, MD PhD

CONTACT

+39-3291649443; ugo.grossi@unipd.it

Chiara Carniel

CONTACT

+39-0422-322817; urc@aulss2.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Assistant Professor of Surgery

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share