HemorrhoidsCHRMICINCT04692194
Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"
An observational study of Hemorrhoids and Chronic Inflammatory Bowel Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Chronic Inflammatory Bowel Disease
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2020to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patient with IBD (Crohn's or UC) with a diagnosis prior to hemorrhoidal surgery, operated on for hemorrhoidal surgery performed between November 1, 2013 and July 7, 2020 in our center
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient with IBD (Crohn's or UC) with a diagnosis prior to hemorrhoidal surgery
- Patient operated on for hemorrhoidal surgery performed between November 1, 2013 and July 7, 2020 in our center
- French-speaking patient
Who cannot join
- Patient with severe inflammatory disease
- Patient with ano-perineal involvement of Crohn's disease
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objecting to the use of their data for this research
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014
About this study
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. In addition, patients with IBD (Crohn's or RectoColitis Haemorrhagic, UC) may have rectal involvement. In both cases, hemorrhoidal surgery can be harmful to the anorectal level. However, recent data from the literature has proven to be reassuring. Indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with IBD, especially when the disease is quiescent.
The main objective is to assess the morbidity of hemorrhoidal surgery in IBD patients who have been operated on at our center. Postoperative complications will be the main elements sought in the study.
The secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with IBD. This requires an exhaustive collection of clinical data.
- Conditions
- Hemorrhoids, Chronic Inflammatory Bowel Disease
- Medical subject headings
- Hemorrhoids
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity from hemorrhoidal surgery
This outcome corresponds to the prevalence of postoperative complications.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start28 Dec 2020
- Primary completion31 Jan 2021
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies 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
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amine ALAM, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692194
- Sponsor's protocol ID
- CHRMICI
- Acronym
- CHRMICI
- Status last verified
- Apr 2023
- First submitted
- 30 Dec 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cracco N, Zinicola R. Is haemorrhoidectomy in inflammatory bowel disease harmful? An old dogma re-examined. Colorectal Dis. 2014 Jul;16(7):516-9. doi: 10.1111/codi.12555.
PubMed 24422778Jeffery PJ, Parks AG, Ritchie JK. Treatment of haemorrhoids in patients with inflammatory bowel disease. Lancet. 1977 May 21;1(8021):1084-5. doi: 10.1016/s0140-6736(77)92337-6.
PubMed 68184McKenna NP, Lightner AL, Habermann EB, Mathis KL. Hemorrhoidectomy and Excision of Skin Tags in IBD: Harbinger of Doom or Simply a Disease Running Its Course? Dis Colon Rectum. 2019 Dec;62(12):1505-1511. doi: 10.1097/DCR.0000000000001524.
PubMed 31580261Lightner AL, Kearney D, Giugliano D, Hull T, Holubar SD, Koh S, Zaghiyan K, Fleshner PR. Excisional Hemorrhoidectomy: Safe in Patients With Crohn's Disease? Inflamm Bowel Dis. 2020 Aug 20;26(9):1390-1393. doi: 10.1093/ibd/izz255.
PubMed 31633186
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"
- ClinicalTrials.gov ID
- NCT04692194
- Acronym / sponsor ID
- CHRMICI / CHRMICI
- Conditions
- Hemorrhoids, Chronic Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 31 Dec 2020 (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.
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. In addition, patients with IBD (Crohn's or RectoColitis Haemorrhagic, UC) may have rectal involvement. In both cases, hemorrhoidal surgery can be harmful to the anorectal level. However, recent data from the literature has proven to be reassuring. Indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with IBD, especially when the disease is quiescent.
The main objective is to assess the morbidity of hemorrhoidal surgery in IBD patients who have been operated on at our center. Postoperative complications will be the main elements sought in the study.
The secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with IBD. This requires an exhaustive collection of clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with IBD (Crohn's or UC) with a diagnosis prior to hemorrhoidal surgery, operated on for hemorrhoidal surgery performed between November 1, 2013 and July 7, 2020 in our center
Key inclusion criteria (4 listed)
- Patient whose age is ≥ 18 years
- Patient with IBD (Crohn's or UC) with a diagnosis prior to hemorrhoidal surgery
- Patient operated on for hemorrhoidal surgery performed between November 1, 2013 and July 7, 2020 in our center
- French-speaking patient
Key exclusion criteria (6 listed)
- Patient with severe inflammatory disease
- Patient with ano-perineal involvement of Crohn's disease
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
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
Morbidity from hemorrhoidal surgery
Time frame: Year 1
This outcome corresponds to the prevalence of postoperative complications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Results publication: PubMed 24422778Cracco N, Zinicola R. Is haemorrhoidectomy in inflammatory bowel disease harmful? An old dogma re-examined. Colorectal Dis. 2014 Jul;16(7):516-9. doi: 10.1111/codi.12555.
- Results publication: PubMed 68184Jeffery PJ, Parks AG, Ritchie JK. Treatment of haemorrhoids in patients with inflammatory bowel disease. Lancet. 1977 May 21;1(8021):1084-5. doi: 10.1016/s0140-6736(77)92337-6.
- Results publication: PubMed 31580261McKenna NP, Lightner AL, Habermann EB, Mathis KL. Hemorrhoidectomy and Excision of Skin Tags in IBD: Harbinger of Doom or Simply a Disease Running Its Course? Dis Colon Rectum. 2019 Dec;62(12):1505-1511. doi: 10.1097/DCR.0000000000001524.
- Results publication: PubMed 31633186Lightner AL, Kearney D, Giugliano D, Hull T, Holubar SD, Koh S, Zaghiyan K, Fleshner PR. Excisional Hemorrhoidectomy: Safe in Patients With Crohn's Disease? Inflamm Bowel Dis. 2020 Aug 20;26(9):1390-1393. doi: 10.1093/ibd/izz255.
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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. This study is not recruiting at the moment.
Amine ALAM, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids and Chronic Inflammatory Bowel Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity from hemorrhoidal surgery (time frame: Year 1). 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 NCT04692194, which also lists 4 linked publications.
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 27 Apr 2023.