Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418438
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
A Randomized Controlled Trail of Uterosacral Ligament Suspension in the Treatment of Pelvic Organ Prolapse
Sponsor:
Lan Zhu
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
To Compare the Clinical Efficacy and Safety of Laparoscopic Uterosacral Ligament Suspension With or Without Hysterectomy in the Treatment of POP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Pelvic organ prolapse POP is one of the common benign gynecological disorders in middle-aged and elderly women which severely affects patients quality of life and increases the social burden The lifetime risk of undergoing surgery for POP is 126 Surgery is an important treatment modality for POP and currently there are various surgical procedures used in clinical practice but there is still no clear consensus on which procedure is superior Autologous tissue repair remains crucial in pelvic floor reconstruction surgery and high uterosacral ligament suspension HUSLS via a vaginal approach is a classic corrective procedure for central pelvic defects However with the development of minimally invasive techniques laparoscopic uterosacral ligament suspension LUSLS has been widely used in the field of pelvic floor reconstruction Compared to the vaginal approach LUSLS is easier to perform has a shorter learning curve provides better exposure of the ureters and allows for higher-quality suture placement under safe conditions The main controversial clinical issue in the industry regarding high uterosacral ligament suspension is whether to perform uterine preservation with the core concern being the risk of postoperative recurrence High uterosacral ligament suspension with uterine preservation achieves level I repair by fixing the lower segment or cervix to supporting structures Its advantages include shorter operation time less blood loss and the preservation of the patients fertility Many women request uterine preservation for various reasons Therefore high-quality research is needed to guide the clinical decision-making regarding uterine preservation in high uterosacral ligament suspension Previous studies have found that approximately 40 of patients with pelvic organ prolapse have concurrent cervical elongation For patients with cervical elongation symptoms in the central pelvic region are mainly caused by the protrusion of elongated cervical tissue into the vagina Removing the elongated cervix significantly reduces the need for biological support in pelvic floor reconstruction making autologous tissue repair strategies the preferred option for this patient population while providing a foundation for uterine preservation Based on long-term observational studies the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital has proposed combining laparoscopic uterosacral ligament suspension with cervical amputation for the treatment of pelvic organ prolapse with cervical elongation This study aims to compare whether uterine preservation in laparoscopic uterosacral ligament suspension is non-inferior to uterine removal providing more treatment options for future patients with pelvic organ prolapse and cervical elongation
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