Anal Fistula and Microdialysis - What is Yet to Learn?

Anal Fistula Clinical Trial

Official title:

Intervention With Microdialysis Measurements in Anal Fistula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178707
• Other study ID #: UMUmea
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: December 20, 2024

Study information

• Verified date: December 2022
• Source: University Hospital, Umeå
• Contact: Karin Strigard, Associate Professor
• Phone: +4673 382 0772
• Email: karin.strigard[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 20, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

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

Locations

Country	Name	City	State
Sweden	Umea University Hospital	Umea	Vasterbotten

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	measurement of lactate in anal fistula using microdialysis	measurement of lactate in fistula using microdialysis, change in value is being assessed	baseline measurement, 1 month follow up
Primary	measurements of glucose in anal fistula using microdialysis	measurements of glucose in fistula using microdialysis, change in value is being assessed	baseline measurement, 1 month follow up
Secondary	measurement of pyruvate in anal fistula using microdialysis	measurement of pyruvate measurements in fistula using microdialysis, change in value is being assessed	baseline measurement, 1 month follow up