Anal Fistula and Microdialysis – What is Yet to Learn?

Overview

Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed.

Full Title of Study: “Intervention With Microdialysis Measurements in Anal Fistula”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2023

Detailed Description

Patients with anal fistula can have a reduced quality of life for years do to fistula complications. This condition is not well researched and more knowledge is needed to provide better care. Microdialysis has been used to study other organs of the body such as the brain, liver and GI-tract. Upcoming study is going to study the inner environment of the anal fistula in regards to lactate, pyruvate and glucose. The study group is patients with anal fistula that with a need for seton treatment. Measurements with microdialysis will take place before operative procedure and one month after getting their seton inserted.

Interventions

  • Device: OnZurf Probe, Senzime AB, Uppsala, Sweden
    • Probe is inserted into the fistula and measurements are made of the inner environment.

Arms, Groups and Cohorts

  • Other: Intervention
    • Using microdialysis the patients inner enviorment of the anal fistula will be measured – levels of lactate, glucose and pyruvate.

Clinical Trial Outcome Measures

Primary Measures

  • measurements of glucose in anal fistula using microdialysis
    • Time Frame: baseline measurement, 1 month follow up
    • measurements of glucose in fistula using microdialysis, change in value is being assessed

Secondary Measures

  • measurement of pyruvate in anal fistula using microdialysis
    • Time Frame: baseline measurement, 1 month follow up
    • measurement of pyruvate measurements in fistula using microdialysis, change in value is being assessed

Participating in This Clinical Trial

Inclusion Criteria

  • over 18 years of age – to be able to understand and accept the terms of study Exclusion Criteria:

  • age under 18 – dementia, language barrier

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Umeå
  • Provider of Information About this Clinical Study
    • Principal Investigator: Karin Gustafsson, Medical Doctor, Principal Investigator – University Hospital, Umeå
  • Overall Official(s)
    • Ulf Gunnarsson, Professor, Study Chair, University Hospital, Umeå
  • Overall Contact(s)
    • Karin Strigard, Associate Professor, +4673 382 0772, karin.strigard@umu.se

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