Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441526
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2019-04-10
Brief Title:
Surgical Closure vs Anti-TNF in the Treatment of Perianal Fistulas in Crohns Disease PISA-II a Comprehensive Cohort Design
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Surgical Closure Versus Anti-TNF in the Treatment of Perianal Fistulas in Crohns Disease PISA-II a Comprehensive Cohort Design
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PISA-II
Brief Summary:
Currently the treatment of Crohns patients with perianal fistulas predominantly exists of anti-TNF medication However its efficiency has never been directly compared to surgical closure of the perianal fistula The aim of this study is to compare radiological fistula healing at MRI after 18 months follow-up in Crohns patients undergoing surgical closure to anti-TNF medication as treatment of perianal Crohns fistulas
Study design In this multicenter comprehensive cohort design CCD Crohns patients with a reactive high perianal fistula will be allocated to anti-TNF for 1 year or surgical closure after 2 months under a short course of anti-TNF Patients with a distinct preference will be treated accordingly whereas only indifferent patients will be randomised in the usual way
Main study parametersendpoints The primary outcome parameter is the number of patients with radiologically closed fistulas based on an evaluated MRI-score after 18 months Secondary outcomes are clinical closure number of patients undergoing surgical re-interventions and number of re-interventions recurrences and quality of life based on the Perianal Disease Activity Index PDAI
Nature and extent of the burden and risks associated with participation benefit and group relatedness All patients will receive one of the two standard treatment approaches that are currently used for Crohns fistulas All effort has been performed to ensure most optimal treatment according to best available evidence and current guidelines Since there is no experimental study-arm there are no additional risks associated with participation During the study the medical staff and trial nurses will monitor the necessity of surgical interventions and hospitalizations At baseline and after 18 months all patients will undergo a MRI to score the fistula Secondary outcome parameters will be assessed during visits to the outpatient clinic or telephone consultations at baseline and at intervals of 3 months for the duration of the study period Every 6 months patients were asked to fill out the PDAI questionnaire with their physician Based on the available literature radiological closure of fistulas is expected in 40 of patients in the surgical closure group compared to 15 in the anti-TNF group The increase in closure rate from 15 to 40 is considered clinically relevant Due to the combination of a preference and randomized cohort the appropriate sample size to detect this 25 difference is flexible and is adjusted for a skewed distribution The minimal sample size in case of a 11 treatment allocation needed to detect this difference with a Chi-square test equals 86 patients alpha 005 power 80 The maximal allowed skewed distribution is set at 14 which will result in a maximal sample size of 116 patients
Study design In this multicenter comprehensive cohort design CCD Crohns patients with a reactive high perianal fistula will be allocated to anti-TNF for 1 year or surgical closure after 2 months under a short course of anti-TNF Patients with a distinct preference will be treated accordingly whereas only indifferent patients will be randomised in the usual way
Main study parametersendpoints The primary outcome parameter is the number of patients with radiologically closed fistulas based on an evaluated MRI-score after 18 months Secondary outcomes are clinical closure number of patients undergoing surgical re-interventions and number of re-interventions recurrences and quality of life based on the Perianal Disease Activity Index PDAI
Nature and extent of the burden and risks associated with participation benefit and group relatedness All patients will receive one of the two standard treatment approaches that are currently used for Crohns fistulas All effort has been performed to ensure most optimal treatment according to best available evidence and current guidelines Since there is no experimental study-arm there are no additional risks associated with participation During the study the medical staff and trial nurses will monitor the necessity of surgical interventions and hospitalizations At baseline and after 18 months all patients will undergo a MRI to score the fistula Secondary outcome parameters will be assessed during visits to the outpatient clinic or telephone consultations at baseline and at intervals of 3 months for the duration of the study period Every 6 months patients were asked to fill out the PDAI questionnaire with their physician Based on the available literature radiological closure of fistulas is expected in 40 of patients in the surgical closure group compared to 15 in the anti-TNF group The increase in closure rate from 15 to 40 is considered clinically relevant Due to the combination of a preference and randomized cohort the appropriate sample size to detect this 25 difference is flexible and is adjusted for a skewed distribution The minimal sample size in case of a 11 treatment allocation needed to detect this difference with a Chi-square test equals 86 patients alpha 005 power 80 The maximal allowed skewed distribution is set at 14 which will result in a maximal sample size of 116 patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None