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Anal Fistula Repair With Platelet-rich Plasma (Aurora)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678936
Recruitment Status : Withdrawn
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment Phase
Rectal Fistula Biological: PRP Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)
Study Start Date : November 2015
Actual Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: PRP
The operation will be performed with application of platelet rich plasma
Biological: PRP
Application of platelet-rich plasma during surgery

No Intervention: non-PRP
The operation will be performed without addition of platelet-rich plasma



Primary Outcome Measures :
  1. Healing rate [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678936


Locations
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Switzerland
University Hospital of Basel
Basel, Switzerland, 4051
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Andreas Lorenz, MD University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02678936    
Other Study ID Numbers: Aurora
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases