Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease" (CHRMICI)

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ClinicalTrials.gov Identifier: NCT04692194

Recruitment Status : Active, not recruiting

First Posted : December 31, 2020

Last Update Posted : January 31, 2022

Sponsor:

Information provided by (Responsible Party):

Groupe Hospitalier Paris Saint Joseph

Study Description

Brief 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. 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.

Condition or disease
Hemorrhoids Chronic Inflammatory Bowel Disease

Study Design

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Study Type :	Observational
Actual Enrollment :	25 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"
Actual Study Start Date :	December 28, 2020
Actual Primary Completion Date :	January 31, 2021
Estimated Study Completion Date :	March 30, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Morbidity from hemorrhoidal surgery [ Time Frame: Year 1 ]
This outcome corresponds to the prevalence of postoperative complications.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692194

Locations

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France
Groupe Hospitalier Paris Saint-Joseph
Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014

Sponsors and Collaborators

Groupe Hospitalier Paris Saint Joseph

Investigators

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Principal Investigator:	Amine ALAM, MD	Groupe Hospitalier Paris Saint Joseph

More Information

Publications of Results:

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. Review.

Jeffery PJ, Parks AG, Ritchie JK. Treatment of haemorrhoids in patients with inflammatory bowel disease. Lancet. 1977 May 21;1(8021):1084-5.

McKenna 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.

Lightner 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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Responsible Party:	Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:	NCT04692194
Other Study ID Numbers:	CHRMICI
First Posted:	December 31, 2020 Key Record Dates
Last Update Posted:	January 31, 2022
Last Verified:	January 2022

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Intestinal Diseases Inflammatory Bowel Diseases Hemorrhoids Gastrointestinal Diseases Digestive System Diseases	Gastroenteritis Rectal Diseases Vascular Diseases Cardiovascular Diseases

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