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Anal Fistula and Microdialysis - What is Yet to Learn?

Intervention With Microdialysis Measurements in Anal Fistula

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04178707
Enrollment
20
Registered
2019-11-26
Start date
2019-12-10
Completion date
2024-12-20
Last updated
2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

Brief 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.

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

DEVICEOnZurf Probe, Senzime AB, Uppsala, Sweden

Probe is inserted into the fistula and measurements are made of the inner environment.

Sponsors

University Hospital, Umeå
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Microdialysis is used to investigate the inner enviorment of anal fistulas. The patient will be its own control with measurements at prior to intervention and after operative procedure.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
measurements of glucose in anal fistula using microdialysisbaseline measurement, 1 month follow upmeasurements of glucose in fistula using microdialysis, change in value is being assessed

Secondary

MeasureTime frameDescription
measurement of pyruvate in anal fistula using microdialysisbaseline measurement, 1 month follow upmeasurement of pyruvate measurements in fistula using microdialysis, change in value is being assessed

Other

MeasureTime frameDescription
measurement of lactate in anal fistula using microdialysisbaseline measurement, 1 month follow upmeasurement of lactate in fistula using microdialysis, change in value is being assessed

Countries

Sweden

Contacts

Primary ContactKarin Strigard, Associate Professor
karin.strigard@umu.se+4673 382 0772
Backup ContactKarin Adamo, PhD student
karin.adamo@umu.se-46703364755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026