Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"

Hemorrhoids Clinical Trial

— CHRMICI  

Official title:

Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692194
• Other study ID #: CHRMICI
• Status: Completed
• Start date: December 28, 2020
• Est. completion date: April 26, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 26, 2023
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammatory Bowel Disease
• Hemorrhoids
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris	Groupe Hospitalier Paris Saint-Joseph

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

Jeffery 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity from hemorrhoidal surgery	This outcome corresponds to the prevalence of postoperative complications.	Year 1