Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722965
Status:
WITHDRAWN
Last Update Posted:
2024-03-19
First Post:
2021-01-21
Brief Title:
Treatment of Lower Transsphincteric Perianal Fistula Fistulotomy With Marsupialization vs Open Wound
Sponsor:
Consorci Sanitari de lAlt Penedès i Garraf
Organization:
Consorci Sanitari de lAlt Penedès i Garraf
Study Overview
Official Title:
Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Feasibility problems to patients recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas
Detailed Description:
This is a multi-center triple blinded randomized clinical trial in which well compare two techniques for the treatment of simple low transsphincteric perianal fistulas 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound There will be an inclussion visit in which personal information will be recorded and the consent will be signed Randomization will be done after inclusion following a balanced blocks model Information of the surgery technic wont be available for the investigator The patients will have a journal in which theyll write their postoperative symptoms Follow up will be done at weeks 2 4 and 6 by the main investigator of each center Data will be based in clinical examination patients diary and medical records Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test or in case needed a multivariate Cox regression analysis The secondary outcomes will be analyzed by comparing times percentages mean or median with parametric or non parametric tests as it corresponds
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None