Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876975
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-05-11
Brief Title:
Vaginal Axis on Magnetic Resonance Imaging After Laparoscopic Pectopexy Surgery a Controlled Study
Sponsor:
Prof Dr Cemil Tascıoglu Education and Research Hospital Organization
Organization:
Prof Dr Cemil Tascıoglu Education and Research Hospital Organization
Study Overview
Official Title:
Vaginal Axis on MRI After Laparoscopic Pectopexy Surgery a Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-05
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 a major public health concern that adversely affects the physical and psychological well-being of women In fact the lifetime risk of POP surgery is 126 highlighting the magnitude of the problem The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse The primary objective of surgical treatment for POP is to mitigate symptoms and restore the pelvic support anatomy Normally the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae lying relatively horizontally to the levator plate and forming an angle of about 130º between the middle and lower vagina Although sacrocolpopexy SCP is considered the gold standard for treating POP it alters the normal anatomical position of the vaginal axis towards the sacral promontory which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse Similarly sacrospinous ligament fixation SSLF increases the risk of anterior vaginal wall prolapse as it deviates the vaginal axis towards the posterior However laparoscopic lateral mesh suspension has recently become popular because it preserves the normal position of the vaginal axis preventing such complications A previous study found that the pectineal ligament Coopers ligament is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis This structure is robust and can hold sutures well and it is possible to find sufficient material for a suture in the lateral part of the iliopectineal ligament facilitating pelvic floor reconstruction This segment of the ligament is located at the second sacral vertebra S2 level which is the optimal level for the physiological axis of the vagina S2 level serves as the anchor point for the physiological axis of the vagina Further studies have demonstrated that laparoscopic pectopexy provides outcomes comparable to those of laparoscopic sacrocolpopexy for supporting the apical compartment during intermediate follow-up duration The current study aimed to investigate the level of anatomical correction following laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging MRI
Detailed Description:
Pelvic organ prolapse POP is a significant health concern that has a negative impact on the physical and psychological well-being of women In fact the lifetime risk of undergoing POP surgery is 126 The most common form of POP involves defects in the anterior vaginal wall accompanied by apical prolapse The primary goal of surgical treatment for POP is to alleviate symptoms and restore the anatomy of the pelvic support The normal position of the vaginal axis is directed posteriorly towards the S3 and S4 vertebrae lying relatively horizontally to the levator plate and forming an angle of about 130º between the middle and lower vagina Sacrocolpopexy SCP is considered the gold standard for treating POP but it alters the normal anatomical position of the vaginal axis towards the sacral promontory which may increase the abdominal pressure load on the anterior wall and cause urge symptoms or de novo anterior compartment prolapse Although sacrospinous ligament fixation SSLF has promising long-term outcomes for correcting the apical anatomy it increases the risk of anterior vaginal wall prolapse like SCP due to the deviation of the vaginal axis towards the posterior Recently laparoscopic lateral mesh suspension which keeps the vaginal axis close to normal has become popular In a previous study it was found that the pectineal ligament Coopers ligament is composed of stronger and more durable tissue than the sacrospinous ligament and arcus tendineus of the fascia pelvis This structure is robust and can hold sutures well Sufficient material for a suture can also be found in the lateral part of the iliopectineal ligament making pelvic floor reconstruction easier This segment of the ligament is located at the second sacral vertebra S2 level which is the optimal level for the physiological axis of the vagina S2 level is the anchor point for the physiological axis of the vagina Further studies have demonstrated comparable outcomes for supporting the apical compartment at intermediate follow-up duration compared to laparoscopic sacrocolpopexy This study aimed to investigate the level of anatomical correction following Laparoscopic pectopexy and compare the vaginal axis of patients with apical genital prolapse to that of nulliparous women using magnetic resonance imaging MRI
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