Addition of Platelet Rich Stroma in the surgical treatment of Crohn’s perianal fistulas improves radiographic healing.
ID
Bron
Verkorte titel
Aandoening
Crohn's disease; Perianal fistula
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Clinical closure combined with radiographic closure of the fistula tract after surgical intervention at 6 months. Clinical closure of fistula tract is defined as closure of the external openings at physical examination. Radiographic closure is defined as the amount of percent decrease in luminal activity measured by hyper intensity on pelvic T2-weighted MRI.
Achtergrond van het onderzoek
This study aims to assess the efficacy of additional injection of Platelet-Rich Stroma in the surgical treatment of Crohn’s perianal fistulas. A prospective case series will be set up that will include patients with Crohn’s fistulas who undergo PRS treatment during fistula surgery. The primary outcome is defined as combined clinical and radiographic closure healing on postoperative MRI. Follow-up MRI will be performed after clinical closure of the fistula tract, preferably within 6 months postoperatively.
This study was already submitted in January 2019 by the researcher. However, due to the transition to the new website of the NTR the study is registered in 2020.
Doel van het onderzoek
Addition of Platelet Rich Stroma in the surgical treatment of Crohn’s perianal fistulas improves radiographic healing.
Onderzoeksopzet
Follow-up until 12 months posteratively
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients with Crohn’s perianal fistulas, defined as one or more perianal fistula tracts in patients with previously endoscopic or histologic confirmed Crohn’s disease.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Presence of pelvic sepsis or abscesses at the time of study entry.
• Perianal fistula is a rectovaginal fistula.
• Any oncological event in the patients history in the previous five years.
• Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8417 |
| Ander register | METC Erasmus MC : MEC-2019-0425 |