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WithdrawnNCT02678936AuroraUpdated Feb 10, 2016

Anal Fistula Repair With Platelet-rich Plasma

A Phase 4 interventional study of PRP in Rectal Fistula, sponsored by University Hospital, Basel, Switzerland. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-02-10.

Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

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Conditions studied

  • Rectal Fistula
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In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

Browse Rectal Fistula studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    PRP

    The operation will be performed with application of platelet rich plasma

    Biological: PRP

  • No intervention
    non-PRP

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

Interventions

  • BiologicalPRP

    Application of platelet-rich plasma during surgery

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What researchers measure

Primary outcomes

  1. Healing rate

    Time frame: 2 Years

Secondary outcomes

  1. Influence of risk factor smoking on healing rate

    Time frame: 2 years

  2. Influence of risk factor high BMI on healing rate

    Time frame: 2 years

  3. Influence of risk factor chronic renal failure on healing rate

    Time frame: 2 years

  4. Influence of sex on healing rate

    Time frame: 2 years

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Study locations

1 site
  • University Hospital of Basel
    Basel, 4051, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02678936
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Feb 10, 2016
Start date
Nov 2015
Primary completion
Nov 2015
Last update
Feb 10, 2016

Study contacts

Andreas Lorenz, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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