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NCT03881436: TractoCA

Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis

Completed NA Last updated 29 March 2022
What this trial tests

NA trial testing MRI with DTI sequence in Inflammatory Bowel Disease in 23 participants. Completed in 12 August 2021.

Timeline
12 August 2019
Primary endpoint
12 August 2021
12 August 2021

Quick facts

Lead sponsorIHU Strasbourg
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment23
Start date12 August 2019
Primary completion12 August 2021
Estimated completion12 August 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

IHU Strasbourg — full company profile →

Who can join

18 and older, any sex, with Inflammatory Bowel Disease or Neoplastic Pathology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Urinary and faecal incontinences generally come from a dysfunction of the pelvic floor muscles, and more particularly the sphincters. Among other causes, they may be related to accidental trauma, obstetric or iatrogenic. On this last point, the incidence of surgical interventions on the bladder collar and on the anal canal on the prevalence of incontinences can be underlined. MRI tractography could be an interesting tool to visualize in 3D the structure of pelvic sphincters and their lesions. It may thereby establish the link with observed dysfunctions, thus potentially providing a complement to the urological and proctographic examinations already carried out. The objective of this study is, first, to define the sensitivity of the MRI tractography for the visualization of the pelvic sphincters architecture regardless of the gender. In a second time, it will give a description of normal and abnormal (pathological cases) tractography, as well as a descriptive post-surgery. The other interest of this study is the assessment of the information provided by pelvic sphincters tractography on a panel of various and frequently encountered situations in clinical routine at the IHU.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evaluation of the anal canal using diffusion tensor imaging (DTI) with fiber tractography: prospective study of treated perianal fistula
    Knaub E, Giraudeau C, Molière S, Venkatasamy A, et al · · 2022 · DOI 10.21203/rs.3.rs-1519407/v1

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Other recruiting trials for Inflammatory Bowel Disease

Currently open trials in the same condition.

Other IHU Strasbourg trials

Trials by the same sponsor.

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Data sources for this page

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