Clinical trial NCT04692194: Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"
Official title: Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids
Chronic Inflammatory Bowel Disease
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Morbidity from hemorrhoidal surgery
timeFrame: Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
state: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Amine ALAM, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.