Clinical trial NCT06072456: Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
Official title: Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
apical prolapse
pectopexy
sacrospinous ligament fixation
Lateral suspension
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaginal axis
timeFrame: at 4th months after the operation
measure: Vaginal distances
timeFrame: at 4th months after the operation
Secondary outcomes:
measure: Prolapse symptoms, Colorectal-Anal Impact Questionnaire
timeFrame: at 4th months after the operation
measure: Prolapse symptoms
timeFrame: at 4th months after the operation
measure: Urinary Symptoms
timeFrame: at 4th months after the operation
measure: Postoperative de novo dyspareunia
timeFrame: at 4th months after the operation
measure: Sexual functions
timeFrame: at 4th months after the operation
measure: Quality of life measures
timeFrame: at 4th months after the operation
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: at 4th months after the operation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cemil Taşcıoğlu Hospital
city: Istanbul
country: Turkey
facility: Prof.Dr.Cemil Taşcıoğlu Hospital
Study officials:
References:
citation: Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.
citation: Pulatoglu C, Yassa M, Turan G, Turkyilmaz D, Dogan O. Vaginal axis on MRI after laparoscopic lateral mesh suspension surgery: a controlled study. Int Urogynecol J. 2021 Apr;32(4):851-858. doi: 10.1007/s00192-020-04596-8. Epub 2020 Nov 11.