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Anal Fistula and Microdialysis - What is Yet to Learn?

NCT ID: NCT04178707

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2024-12-20

Brief Summary

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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

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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.

Conditions

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Anal Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention

Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate.

Group Type OTHER

OnZurf Probe, Senzime AB, Uppsala, Sweden

Intervention Type DEVICE

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

Interventions

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OnZurf Probe, Senzime AB, Uppsala, Sweden

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Umeå

OTHER

Sponsor Role lead

Responsible Party

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Karin Gustafsson

Medical Doctor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulf Gunnarsson, Professor

Role: STUDY_CHAIR

University Hospital, Umeå

Locations

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Umea University Hospital

Umeå, Västerbotten County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Karin Strigard, Associate Professor

Role: CONTACT

Phone: +4673 382 0772

Email: [email protected]

Karin Adamo, PhD student

Role: CONTACT

Phone: -46703364755

Email: [email protected]

Facility Contacts

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Karin Stigard, Associate Professor

Role: primary

Karin Adamo, MD

Role: backup

Other Identifiers

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UMUmea

Identifier Type: -

Identifier Source: org_study_id