Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471049
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-12
Brief Title:
Study Evaluating the Success Rate of Outpatient Management of the Total Benign Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES Compared to Each of the Two Laparoscopic Routes Conventional and Robot-assisted
Sponsor:
Elsan
Organization:
Elsan
Study Overview
Official Title:
Prospective Controlled Randomized Study Evaluating the Success Rate of Outpatient Management of the Total Benign Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES Compared to Each of the Two Laparoscopic Routes Conventional and Robot-assisted
Status:
RECRUITING
Status Verified Date:
2024-06
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:
HYSTERAMBU
Brief Summary:
Benign total hysterectomy is one of the most commonly performed gynecological surgery
Conventionally performed by a classical surgical approach it is now provided routinely and for several years by laparoscopy and more recently by Robotic-Assisted Laparoscopy
A third minimally invasive option is currently being developed and proposed to avoid trans-peritoneal access using a vaginal trans-laparoscopic technique defined by the name V-NOTES Vaginal-Natural Orifice Transluminal Endoscopic Surgery
These minimally invasive approaches have simplified this intervention on many surgical and anesthetic parameters signing surgical trauma pain and post-operative ileus recovery of autonomy and consider possible management in the outpatient sector
This study aims at enrolling women for which a total hysterectomy with or without annexectomy for the treatment of a benign pathology must be scheduled
The objective of the study is to compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the laparoscopic route assisted robot
Conventionally performed by a classical surgical approach it is now provided routinely and for several years by laparoscopy and more recently by Robotic-Assisted Laparoscopy
A third minimally invasive option is currently being developed and proposed to avoid trans-peritoneal access using a vaginal trans-laparoscopic technique defined by the name V-NOTES Vaginal-Natural Orifice Transluminal Endoscopic Surgery
These minimally invasive approaches have simplified this intervention on many surgical and anesthetic parameters signing surgical trauma pain and post-operative ileus recovery of autonomy and consider possible management in the outpatient sector
This study aims at enrolling women for which a total hysterectomy with or without annexectomy for the treatment of a benign pathology must be scheduled
The objective of the study is to compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the laparoscopic route assisted robot
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