Back to resultsAnal Fistula and Microdialysis - What is Yet to Learn?
Primary Purpose
Anal Fistula
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
OnZurf Probe, Senzime AB, Uppsala, Sweden
Sponsored by
About this trial
This is an interventional basic science trial for Anal Fistula
Eligibility Criteria
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
Sites / Locations
- Umea University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate.
Outcomes
Primary Outcome Measures
measurements of glucose in anal fistula using microdialysis
measurements of glucose in fistula using microdialysis, change in value is being assessed
Secondary Outcome Measures
measurement of pyruvate in anal fistula using microdialysis
measurement of pyruvate measurements in fistula using microdialysis, change in value is being assessed
Full Information
NCT ID
NCT04178707
First Posted
October 25, 2019
Last Updated
December 12, 2022
Sponsor
University Hospital, Umeå
1. Study Identification
Unique Protocol Identification Number
NCT04178707
Brief Title
Anal Fistula and Microdialysis - What is Yet to Learn?
Official Title
Intervention With Microdialysis Measurements in Anal Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Umeå
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate.
Intervention Type
Device
Intervention Name(s)
OnZurf Probe, Senzime AB, Uppsala, Sweden
Intervention Description
Probe is inserted into the fistula and measurements are made of the inner environment.
Primary Outcome Measure Information:
Title
measurements of glucose in anal fistula using microdialysis
Description
measurements of glucose in fistula using microdialysis, change in value is being assessed
Time Frame
baseline measurement, 1 month follow up
Secondary Outcome Measure Information:
Title
measurement of pyruvate in anal fistula using microdialysis
Description
measurement of pyruvate measurements in fistula using microdialysis, change in value is being assessed
Time Frame
baseline measurement, 1 month follow up
Other Pre-specified Outcome Measures:
Title
measurement of lactate in anal fistula using microdialysis
Description
measurement of lactate in fistula using microdialysis, change in value is being assessed
Time Frame
baseline measurement, 1 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Strigard, Associate Professor
Phone
+4673 382 0772
Email
karin.strigard@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Adamo, PhD student
Phone
-46703364755
Email
karin.adamo@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Gunnarsson, Professor
Organizational Affiliation
University Hospital, Umeå
Official's Role
Study Chair
Facility Information:
Facility Name
Umea University Hospital
City
Umea
State/Province
Vasterbotten
ZIP/Postal Code
90381
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Stigard, Associate Professor
Phone
+46733820772
Email
karin.strigard@umu.se
First Name & Middle Initial & Last Name & Degree
Karin Adamo, MD
Phone
+46703364755
Email
karin.adamo@umu.se
12. IPD Sharing Statement
Learn more about this trial
Anal Fistula and Microdialysis - What is Yet to Learn?
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