NCT02678936

Brief Summary

Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate. The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

Same day

First QC Date

December 19, 2014

Last Update Submit

February 5, 2016

Conditions

Rectal Fistula

Outcome Measures

Primary Outcomes (1)

  • Healing rate

    2 Years

Secondary Outcomes (4)

  • Influence of risk factor smoking on healing rate

    2 years

  • Influence of risk factor high BMI on healing rate

    2 years

  • Influence of risk factor chronic renal failure on healing rate

    2 years

  • Influence of sex on healing rate

    2 years

Study Arms (2)

PRP

EXPERIMENTAL

The operation will be performed with application of platelet rich plasma

Biological: PRP

non-PRP

NO INTERVENTION

The operation will be performed without addition of platelet-rich plasma

Interventions

PRPBIOLOGICAL

Application of platelet-rich plasma during surgery

PRP

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • complicated anal fistula with patient fit for surgical treatment
  • minimum 6 weeks after
  • written informed consent

You may not qualify if:

  • age \<18
  • pregnancy
  • drug abuse, drug substitution program
  • homeless (follow-up difficult)
  • restricted in legal capacity
  • simple fistulas requiring fistulotomy
  • complicated fistulas requiring an anus praeter naturalis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Basel

Basel, 4051, Switzerland

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

  • Andreas Lorenz, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

February 10, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

CH(1)