Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05715983
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-08
First Post:
2023-01-27
Brief Title:
Comparison of Laser Destruction of Pilonidal Sinus Disease SILAC and Bascom II Procedure
Sponsor:
Russian Society of Colorectal Surgeons
Organization:
Russian Society of Colorectal Surgeons
Study Overview
Official Title:
Comparison of Laser Destruction of Pilonidal Sinus Disease SILAC and Bascom
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
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:
SI-BAS
Brief Summary:
Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease But nowadays minimally invasive treatment methods such as the use of a diode laser SiLac Sinus Laser Closure to obliterate the coccygeal tract are used more often The aim of the study is to compare a new minimal invasive method laser treatment with traditional method Bascom II in terms of recurrence rate complications and patients satisfaction with results
Detailed Description:
Pilonidal sinus disease PSD is 26 cases per 100000 population affects primarily young adults One of the problems of surgical treatment of PSD is the frequent development of recurrence There are various methods of surgical treatment but the recurrence rate still high up to 67
Nowadays minimally invasive methods for PSD eg the use of a diode laser for sinus obliteration- SiLac Sinus Laser Closure compete with traditional methods This day-surgery method significantly reduces the risk of postoperative complications allows a quicker return to normal daily activity preserves the intergluteal cleft and provides the best cosmetic results According to some authors the recurrence rate in this method is up to 26 parallel others- recurrence rate is less 3 but the follow-up does not exceed 2 years
On the other hand the excision of the PSD with the mobilization of the skin-subcutaneous flap which leads to the lateralization of the postoperative scar to one side of the intergluteal cleft hereby providing a low recurrence rate up to 4
Thus despite the increased use of minimally invasive surgery excision of the pilonidal sinus disease cannot be undoubtedly abandoned due to the lack of comparative studies
Nowadays minimally invasive methods for PSD eg the use of a diode laser for sinus obliteration- SiLac Sinus Laser Closure compete with traditional methods This day-surgery method significantly reduces the risk of postoperative complications allows a quicker return to normal daily activity preserves the intergluteal cleft and provides the best cosmetic results According to some authors the recurrence rate in this method is up to 26 parallel others- recurrence rate is less 3 but the follow-up does not exceed 2 years
On the other hand the excision of the PSD with the mobilization of the skin-subcutaneous flap which leads to the lateralization of the postoperative scar to one side of the intergluteal cleft hereby providing a low recurrence rate up to 4
Thus despite the increased use of minimally invasive surgery excision of the pilonidal sinus disease cannot be undoubtedly abandoned due to the lack of comparative studies
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