HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study (HEAD-IBD-II)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety; Hemorrhoid; Surgery Related Complications Rate; IBD (Inflammatory Bowel Disease); Sugery

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ugo Grossi, MD PhD; Phone Number: +39-3291649443; Email: ugo.grossi@unipd.it
• Study Contact Backup: Name: Chiara Carniel; Phone Number: +39-0422-322817; Email: urc@aulss2.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Treviso Regional Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; IBD; Hemorrhoidal disease; HEAD-IBD-II
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Gastroenteritis; Rectal Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Hemorrhoids
• Other Study ID Numbers: HEAD-IBD-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No