Anal Fistula and Microdialysis - What is Yet to Learn?

Not Applicable

Recruiting

• Conditions: Anal Fistula
• Interventions: Device: OnZurf Probe, Senzime AB, Uppsala, Sweden

• Registration Number: NCT04178707
• Lead Sponsor: University Hospital, Umeå

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.

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Study Start: 2019-12-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13
• Primary Completion: 2023-11-30
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	OnZurf Probe, Senzime AB, Uppsala, Sweden	Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Umea University Hospital; 🇸🇪 Umea, Vasterbotten, Sweden