NCT05876975

Vaginal Axis on Magnetic Resonance Imaging After Laparoscopic Pectopexy Surgery: a Controlled Study

Status unknown NA Last updated 26 May 2023

What this trial tests

NA trial testing laparoscopic pectopexy in Pelvic Organ Prolapse in 21 participants. Status unknown.

Timeline

4 January 2023

Primary endpoint
4 June 2023

1 July 2023

Quick facts

Lead sponsor	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	4 January 2023
Primary completion	4 June 2023
Estimated completion	1 July 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• laparoscopic pectopexy

Conditions studied

• Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Who can join

Adults 18 to 80, female only, with Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 12.6%, 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 (Cooper's 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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vaginal axis on MRI after laparoscopic pectopexy surgery: a controlled study
   sahin f, bayraktarli ry. · · 2023 · DOI 10.21203/rs.3.rs-3263718/v1