Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140199
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-11-14
Brief Title:
Comparing Minimally Invasive Treatments for Pilonidal Disease LA POPA Trial Laser And Pit-picking OR Pit-picking Alone
Sponsor:
dr IJM Han-Geurts
Organization:
Proctos Kliniek
Study Overview
Official Title:
Comparing Minimally Invasive Treatments for Pilonidal Disease LA POPA Trial Laser And Pit-picking OR Pit-picking Alone
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
LA POPA
Brief Summary:
The goal of this randomized clinical trial is to establish the efficacy of pit picking with laser therapy versus pit picking alone on both short and long-term outcomes in patients of 12 years and older with primary pilonidal sinus disease
The main questions it aims to answer are
The overall success rate of treatment which is defined as closure of all pits at 12 months of follow-up
Secondary endpoints succes rat eof treatment during long-term follow-up wound closure time pain scores complication rate work rehabilitation time to return to daily activities quality of life persisting complaints patient satisfaction costs and the need for secondary or revision surgery
Participants will allocated to pit picking alone or combined with lasertherapy
The extra burden for participating patients is expected to be minimal to moderate Participants will have two extra hospital visits in casethey are enrolled in our study 6 and 12 months after enrolment Postoperatively the normal scheme of follow up appointments wil be used 2 and 6 weeks after treatment at the outpatient clinic of the treating surgeon A telephone appointment with the researcher will be scheduled 4 weeks after treatment Patients are asked to complete questionnaires at various time points which will be sentto them by email and will take approximately 5-10 minutes each time The content includes general and disease specific Quality of Life QoL questionnaires The investigators do not expect any extra adverse reactions or events in respect to participation in the study because both procedures are considered standard of care in the participating clinics However because both interventions are surgical procedures a small percentage of adverse events or postoperative complications can be expected
The main questions it aims to answer are
The overall success rate of treatment which is defined as closure of all pits at 12 months of follow-up
Secondary endpoints succes rat eof treatment during long-term follow-up wound closure time pain scores complication rate work rehabilitation time to return to daily activities quality of life persisting complaints patient satisfaction costs and the need for secondary or revision surgery
Participants will allocated to pit picking alone or combined with lasertherapy
The extra burden for participating patients is expected to be minimal to moderate Participants will have two extra hospital visits in casethey are enrolled in our study 6 and 12 months after enrolment Postoperatively the normal scheme of follow up appointments wil be used 2 and 6 weeks after treatment at the outpatient clinic of the treating surgeon A telephone appointment with the researcher will be scheduled 4 weeks after treatment Patients are asked to complete questionnaires at various time points which will be sentto them by email and will take approximately 5-10 minutes each time The content includes general and disease specific Quality of Life QoL questionnaires The investigators do not expect any extra adverse reactions or events in respect to participation in the study because both procedures are considered standard of care in the participating clinics However because both interventions are surgical procedures a small percentage of adverse events or postoperative complications can be expected
Detailed Description:
None
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