Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Procedure: laparoscopic pectopexy

Procedure: laparoscopic lateral suspension

Procedure: Sacrospinous ligament fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT06072456

E-10840098-772.02-4704

Details and patient eligibility

About

Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. Recent years have witnessed a proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension, pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered extensive clinical application, in relation to recurrence rates. A multitude of investigations have been undertaken to delineate the optimal vaginal axis. In the present investigation, we have delineated a research protocol aimed at scrutinizing these alternative surgical modalities with regard to their impact on the vaginal axis.

Full description

The study objective pertains to the assessment of vaginal axis in patients undergoing apical prolapse surgery, whether they have undergone hysterectomy or not. The investigation is designed to test the null hypothesis by means of a comparative analysis of preoperative and postoperative Magnetic Resonance Imaging images capturing the vaginal axis. This examination will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and sacrospinous ligament fixation procedures for the correction of apical prolapse.

Enrollment

60 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female with genital prolapse

Exclusion criteria

Patients who had pouch of Douglas obliteration
Patients with enterocele
Patients who have any congenital or acquired anatomic and reproductive anomaly

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 5 patient groups

lateral suspension

Experimental group

Description:

Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. Preoperative and postoperative MRI results were evaluated

Treatment:

Procedure: laparoscopic lateral suspension

pectopexy

Experimental group

Description:

The cervix or vaginal cuff was suspended by the Cooper ligament.Preoperative and postoperative MRI results were evaluated

Treatment:

Procedure: laparoscopic pectopexy

sacrospinous ligament fixation

Experimental group

Description:

vaginal cuff/uterus was sutured to the unilateral sacrospinous ligament.Preoperative and postoperative MRI results were evaluated