Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518499
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Outcomes of Karydakis Primary Closure and Pit Picking Methods in the Treatment of Pilonidal Sinus A Prospective Study in Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcomes of Karydakis Primary Closure and Pit Picking Methods in the Treatment of Pilonidal Sinus A Prospective Study in Women
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although there are many methods for the surgical treatment of pilonidal sinus disease the number of studies specific to women is limited in the literature In addition to post-treatment recurrence and complication rates in women aesthetic results are also of great importance This study will compare the Karydakis procedure a flap method and the Bascoms pit-pick procedure a minimally invasive procedure in terms of recurrence complications and aesthetics especially in female patients with three or fewer pits
Detailed Description:
This study is a single-center prospective observational trial aimed at comparing the effectiveness of the Karydakis flap and Bascoms pit-pick methods in treating pilonidal sinus disease in women Female patients aged 18 and over with three or fewer pits will be included and each patient will be followed for 12 months The Bascom pit-pick method will be performed under local anesthesia while the Karydakis method will be performed under spinal or general anesthesia Postoperative recovery time complications recurrence rates and patient satisfaction will be evaluated Ethics committee approval has been obtained Approval No TE 172 Date June 12 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None