NCT04692194|Completed
Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"
CHRMICI
Loading search results
CHRMICI
Sponsor study identifier
observational
25
1 country
1
Study Start
December 28, 2020
Actual (reported)Primary Completion
January 31, 2021
Actual (reported)Study Completion
April 26, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 26, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 28, 2020
Actual (reported)December 30, 2020
Actual (reported)December 31, 2020
Actual (reported)January 31, 2021
Actual (reported)April 26, 2023
Actual (reported)Morbidity from hemorrhoidal surgery
This outcome corresponds to the prevalence of postoperative complications.
Year 1
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
Groupe Hospitalier Paris Saint-Joseph
Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France
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.
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.
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.
Amine ALAM, MD
Fondation Hôpital Saint-Joseph
25 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2020
First Posted
December 31, 2020
Study Start
December 28, 2020
Actual (reported)Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease
Contact the study team to confirm eligibility.
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.
Primary Completion
January 31, 2021
Actual (reported)Study Completion
April 26, 2023
Actual (reported)Last Updated
April 27, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: