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OpenTrials
Completed

NCT Number: NCT04692194

Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"

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.

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Chronic Inflammatory Bowel Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint-Joseph

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Morbidity from hemorrhoidal surgery

    Time frame: Year 1

    This outcome corresponds to the prevalence of postoperative complications.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: CHRMICI

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Dec 31, 2020
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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