Anal Fistula and Microdialysis - What is Yet to Learn?

NCT04178707 | Unknown DMC

• 1 other identifier: UMUmea
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• measurement of pyruvate in anal fistula using microdialysis

  baseline measurement, 1 month follow up

Other Outcomes (1)

• measurement of lactate in anal fistula using microdialysis

  baseline measurement, 1 month follow up

Study Arms (1)

Intervention

OTHER

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

Interventions

OnZurf Probe, Senzime AB, Uppsala, Sweden DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years of age
• to be able to understand and accept the terms of study

You may not qualify if:

• age under 18
• dementia, language barrier

Sponsors & Collaborators

• University Hospital, Umeå: lead

Study Sites (1)

Umea University Hospital

Umeå, Västerbotten County, 90381, Sweden

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Gunnarsson, Professor

  University Hospital, Umeå

  STUDY CHAIR

Central Study Contacts

Karin Strigard, Associate Professor

CONTACT

+4673 382 0772; karin.strigard@umu.se

Karin Adamo, PhD student

CONTACT

-46703364755; karin.adamo@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 26, 2019
• Study Start: December 10, 2019
• Primary Completion: November 30, 2023
• Study Completion: December 20, 2024
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

SE (1)