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

NCT ID: NCT06638814

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-01-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Treviso Regional Hospital

NETWORK

Sponsor Role: lead

Responsible Party

Ugo Grossi

MD PhD, Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ugo Grossi, MD PhD

Role: CONTACT

ugo.grossi@unipd.it

+39-3291649443

Chiara Carniel

Role: CONTACT

urc@aulss2.veneto.it

+39-0422-322817

References

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.

Reference Type: BACKGROUND

PMID: 35160159 (View on PubMed)

Other Identifiers

HEAD-IBD-II

Identifier Type: -

Identifier Source: org_study_id