Anal Fistula Repair With Platelet-rich Plasma

Rectal Fistula Clinical Trial

— Aurora  

Official title:

Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02678936
• Other study ID #: Aurora
• Status: Withdrawn
• Phase: Phase 4
• First received: December 19, 2014
• Last updated: February 5, 2016
• Start date: November 2015

Study information

• Verified date: February 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Rectal Fistula

Intervention

Biological:
• PRP
Application of platelet-rich plasma during surgery

Locations

Country	Name	City	State
Switzerland	University Hospital of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate		2 Years	No
Secondary	Influence of risk factor smoking on healing rate		2 years	No
Secondary	Influence of risk factor high BMI on healing rate		2 years	No
Secondary	Influence of risk factor chronic renal failure on healing rate		2 years	No
Secondary	Influence of sex on healing rate		2 years	No