Clinical trial NCT03421457: Laparoscopic Lateral Suspension With Mesh & Sacrocervicopexy for the Treatment of Uterine Prolapse
Official title: A Multicenter, Randomized, Prospective, Controlled Study Comparing Uterine Preserving Laparoscopic Lateral Suspension With Mesh Versus Laparoscopic Sacrocervicopexy in the Treatment of Uterine Prolapse: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Pelvic Floor Prolapse
Keywords: Pelvic Organ Prolapse
Translabial ultrasound
Transperineal ultrasound
Lateral Mesh Suspension
Descensus uteri
Laparoscopic pelvic organ prolapse repair
Uterus preserving
hysteropexy
uterine-preserving
fertility-sparing
sacropexy
cervicopexy
sacrocervicopexy
sacrohysteropexy
mesh prolapse surgery
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Sisli Hamidiye Etfal Training and Research Hospital
First posted: 2018-02-05
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.

Detailed description: Patient with uterine prolapse can participate in this study. A total of 44 women will be included. At random 22 patients undergo laparoscopic lateral suspension with mesh operation and 22 patients undergo laparoscopic sacrohysteropexy operation. Evaluation will take place during the surgery, at the postoperative visit after 4 weeks, 6th months and 12th months. Quality of life, degree of vaginal prolapse, safety, operation time and complications will be evaluated.

Subjective assessments will include Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS).

Objective assessments will include routine gynecologic sonography, Pelvic Organ Prolapse Quantification System (POP-Q) and pelvic floor biometry measured by transperineal sonography.

Transperineal sonography will include those measurements:

Urethral rotation, Pelvic organ descent, Hiatal Diameter and the Anatomical localization of apex.

Eligibility criteria: Inclusion Criteria:

* \>18 years old
* \> Symptomatic prolapse of central compartment with a Pelvic Organ Prolapse Quantitative (POP-Q) stage 2 associated or not with anterior or posterior compartment prolapse.
* Patients who are not comfortable with using or refusing pessary
* Wish to preserve the uterus

Exclusion Criteria:

* Any cue for gynecologic oncological condition
* Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse

Primary outcomes:
measure: Change from baseline POP-Q measurements (mm) at 12th month.
timeFrame: 12 months for each participant
Secondary outcomes:
measure: Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 12th month.
timeFrame: 12 months for each participant
measure: Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 12th month.
timeFrame: 12 months for each participant
measure: Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 12th month.
timeFrame: 12 months for each participant
measure: Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 12th month.
timeFrame: 12 months for each participant
measure: Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 12th month.
timeFrame: 12 months for each participant
measure: Change from baseline Pelvic Hiatus measurements (mm) at 12th month.
timeFrame: 12 months for each participant
measure: Change from baseline Pelvic biometry measurements at 12th month.
timeFrame: 12 months for each participant
measure: Change from baseline bladder neck mobility measurements at 12th month.
timeFrame: 12 months for each participant
measure: Failure (%)
timeFrame: 12 months for each participant
measure: Complications
timeFrame: 12 months for each participant
measure: Operation time
timeFrame: Operation time will noted for each participant at the same day of the operation. Operation time will be determined with using a chronometer,from the time of first skin incision until the suturing the skin of the trocar entry, assessed up to 52 weeks.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital, Sancaktepe Campus
state: Sancaktepe
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
state: Sisli
Study officials:
affiliation: Chief of the Department
name: Niyazi Tug, As.Prof.
role: STUDY_DIRECTOR
References:
citation: Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17.