Clinical Trial: Is the Use of Blood Platelets Effective in the Treatment of Difficult Fistulas Related to the Anal Sphincter?

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Use of Platelet Rich Plasma (PRP) as an Adjunct in the Treatment of High Peri-anal Fistulas.

Brief Summary:

Rationale:

Closure of the internal opening is the most accepted standard procedure in the treatment of peri-anal fistulas. The mucosal advancement flap is considered as golden standard. In one out of the three patients mucosal flap repair fails. Possible causal factors are incomplete clearance of pus and debris, incomplete closure of the internal opening, inappropriate host response in patients with risk factors like smoking or diabetes. Platelet derived growth factors may facilitate closure of the internal opening, especially in patients with impaired wound healing.

Objective:

The use of autologous platelet rich plasma (PRP) as an adjunct to the staged mucosal advancement flap to achieve a better closure rate of complex peri-anal fistula's.

Study design:

Randomized, multicenter trial.

Study population:

Patients with complex cryptoglandular peri-anal fistula's.

Intervention:

Injection of PRP in the curretted fistula track under the mucosal flap.

Main study parameters/endpoints:

• Recurrence rate
• Post-operative pain
• Continence
• Quality of life.

Nature and extent of the burden and risks associated with participation, group relatedness:

Because aut

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Recurrence of fistulas [ Time Frame: Assessed up to 104 weeks after operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Pain [ Time Frame: Assessed at 2 weeks after operation ]
  Measured using the Visual Analogue Scale (VAS-score)
• Quality of Life [ Time Frame: Assessed at 2 weeks after operation ]
  Measured using the SF-36v2 questionnaire
• Incontinence [ Time Frame: Assessed at 2 weeks after operation ]
  Measured using the Vaizey score
• Pain [ Time Frame: Assessed at 4 weeks after operation ]
  Measured using the Visual Analogue Scale (VAS-score)
• Pain [ Time Frame: Assessed at 16 weeks after operation ]
  Measured using the Visual Analogue Scale (VAS-score)
• Pain [ Time Frame: Assessed at 24 weeks after operation ]
  Measured using the Visual Analogue Scale (VAS-score)
• Pain [ Time Frame: Assessed at 52 weeks after operation ]
  Measured using the Visual Analogue Scale (VAS-score)
• Pain [ Time Frame: Assessed at 104 weeks after operation ]
  Measured using the Visual Analogue Scale (VAS-score)
• Quality of life [ Time Frame: Assessed at 4 weeks after operation ]
  Measured using the SF-36v2 questionnaire
• Quality of Life [ Time Frame: Assessed at 16 weeks after operation ]
  Measured using the SF-36v2 questionnaire
• Quality of life [ Time Frame: Assessed at 24 weeks after operation ]
  Measured using the SF-36v2 questionnaire
• Quality of life [ Time Frame: Assessed at 52 weeks after operation ]
  Measured using the SF-36v2 questionnaire
• Quality of life [ Time Frame: Assessed at 104 weeks after operation ]
  Measured using the SF-36v2 questionnaire
• Incontinence [ Time Frame: Assesed at 4 weeks after operation ]
  Measured using the Vaizey score
• Incontinence [ Time Frame: Assessed at 16 weeks after operation ]
  Measured using the Vaizey score
• Incontinence [ Time Frame: Assessed at 52 weeks after operation ]
  Measured using the Vaizey score
• Incontinence [ Time Frame: Assessed at 24 weeks after operation ]
  Measured using the Vaizey score
• Incontinence [ Time Frame: Assessed at 104 weeks after operation ]
  Measured using the Vaizey score

Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: May 30, 2012
Date Started: March 2012
Date Completion: April 2016
Last Updated: August 21, 2012
Last Verified: August 2012