Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578767
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias the X-DECO Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias Results After 1 Year of Follow-up the X-DECO Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
X-DECO
Brief Summary:
The objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up on pain experience and anxiety depression post-traumatic stress syndrome and quality of life
Detailed Description:
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvic perineal pain The compression of both of the nerves are thought to be associated in approximately 25 of the pudendal neuralgias The failure of the isolated pudendal decompression led in the early 2000s to the identification of an entrapment syndrome of the posterior femoral cutaneous nerve and its inferior cluneal branche around the ischial tuberosity This subsequent neuralgia affects the posterior part of the perineum lower buttock and the posterior part of the thigh without any associated neuro-vegetative symptoms unlike in pudendal neuralgia In case of failure of the medical treatment the open trans-gluteal decompression was proposed as a gold standard However this technique remains invasive and requires a long recovery In a previous study the investigators demonstrated the feasibility of double decompression via a minimally invasive robot-assisted laparoscopic approach and described a 4-step technique
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