NCT04187651

Brief Summary

In treatment of perianal fistula several methods are described. However, since the Hippocrates basics of surgical treatment has not changed very much. the aim of this study is to evaluate the effectiveness of PRP gel in treatment of perianal fistula.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2019Dec 2026

Study Start

First participant enrolled

November 20, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

December 2, 2019

Last Update Submit

April 30, 2026

Conditions

Fistula in Ano

Outcome Measures

Primary Outcomes (1)

  • percentage of the cure rate

    closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging

    1 month

Study Arms (1)

PRP gel application

EXPERIMENTAL

PRP application for perianal fistula

Other: platelet rich plasma

Interventions

platelet rich plasmaOTHER

platelet rich plasma prepared from the patients' own blood will be applied to the fistula tract

PRP gel application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with perianal fistula
  • signing the informed consent form
  • above the age of 18

You may not qualify if:

  • inflammatory bowel disease
  • previous radiation therapy
  • having connective tissue disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uşak University

Uşak, 64100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Barış Sevinç, M.D.

    Uşak University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: PRP gel will be applicated to all cases
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 5, 2019

Study Start

November 20, 2019

Primary Completion

January 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)