IBD (Inflammatory Bowel Disease)HEAD-IBD-IINCT06638814
HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study
An observational study of IBD (Inflammatory Bowel Disease) and Hemorrhoid, run by Treviso Regional Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Hemorrhoid, Safety
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Jan 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Keywords
- HEAD-IBD-II, Hemorrhoidal disease, IBD, Surgery
- Medical subject headings
- Inflammatory Bowel Diseases, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Treviso Regional Hospital
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ugo Grossi, Treviso Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638814
- Sponsor's protocol ID
- HEAD-IBD-II
- Acronym
- HEAD-IBD-II
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 35160159
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06638814
- Acronym / sponsor ID
- HEAD-IBD-II / HEAD-IBD-II
- Conditions
- IBD (Inflammatory Bowel Disease), Hemorrhoid, Safety, Sugery, Surgery Related Complications Rate
- Keywords
- HEAD-IBD-II, Hemorrhoidal disease, IBD, Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Treviso Regional HospitalResearch network
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety and effectiveness of surgical treatments for hemorrhoidal disease
Time frame: 12 months from surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 35160159Grossi 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease) and Hemorrhoid, run by Treviso Regional Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ugo Grossi, MD PhD (+39-3291649443, ugo.grossi@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and effectiveness of surgical treatments for hemorrhoidal disease (time frame: 12 months from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.