Anal Fistula and Microdialysis - What is Yet to Learn?

Intervention With Microdialysis Measurements in Anal Fistula

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.

Study Overview

• Status: Recruiting
• Conditions: Anal Fistula
• Intervention / Treatment: Device: OnZurf Probe, Senzime AB, Uppsala, Sweden

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Strigard, Associate Professor; Phone Number: +4673 382 0772; Email: karin.strigard@umu.se
• Study Contact Backup: Name: Karin Adamo, PhD student; Phone Number: -46703364755; Email: karin.adamo@umu.se

Study Locations

• Sweden
  • Vasterbotten
    • Umea, Vasterbotten, Sweden, 90381
      • Recruiting
      • Umea University Hospital
      • Contact: Karin Stigard, Associate Professor; Phone Number: +46733820772; Email: karin.strigard@umu.se
      • Contact: Karin Adamo, MD; Phone Number: +46703364755; Email: karin.adamo@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate.	Device: OnZurf Probe, Senzime AB, Uppsala, Sweden; Probe is inserted into the fistula and measurements are made of the inner environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Umeå
• Investigators: Study Chair: Ulf Gunnarsson, Professor, University Hospital, Umeå

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 20, 2024

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: November 24, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: UMUmea

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No