Clinical trial NCT05143658: Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
Official title: Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pectopexy
lateral suspension
pelvic organ prolapse
uterine sparing
laparoscopy
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q \>2) at 1 year and yearly up to 2 years.

Detailed description: Primary and secondary endpoints:

Primary outcome measures will be the subjective cure of prolapse ("absence or presence of a bulge in the vagina"), objective success with anatomic absence of advanced prolapse at POP-Q sites Ba, C and Bp defined as less than 1 cm individually and as a total.

Secondary outcome measures include all other parameters such as perioperative outcomes, patient satisfaction, quality of life outcomes, complications, scores on questionnaires, and reoperations.

The study protocol will be submitted to the institutional review boards of every participating study site and written informed consent will be obtained from all participants on enrolment.

Project design: The investigators will perform an international multicentre single-blind randomized controlled trial with participating our tertiary referral hospital.

Eligibility criteria: Inclusion Criteria:

* Women with symptomatic stage 2 or greater (point C -1 or more pelvic organ prolapse quantification POP-Q) apical prolapse

Exclusion Criteria:

* Women not eligible for surgery for medical or anesthesiological reasons
* Inability to comprehend questionnaires
* Inability to give informed consent
* Inability to return for a review
* Prior laparoscopic prolapse repair
* Prior vaginal mesh prolapse procedure
* Severe cardiovascular or respiratory disease
* Women who don't want uterine preserving surgery
* Pregnancy
* Age \<18 years, Age \>45 years

Primary outcomes:
measure: Subjective cure rate of prolapse
timeFrame: [ Time Frame: 12 months after intervention ]
measure: Objective success
timeFrame: [ Time Frame: 12 months after intervention ]
Secondary outcomes:
measure: Prolapse-related Quality of life
timeFrame: [ Time Frame: 12 months after intervention ]
measure: Failure (%)
timeFrame: [ Time Frame: 12 months after intervention ]
measure: Complications
timeFrame: [ Time Frame: 12 months after intervention ]
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: [ Time Frame: 12 months after intervention ]
measure: Incontinence Impact Questionnaire (IIQ-7)
timeFrame: [ Time Frame: 12 months after intervention ]
measure: Pelvic Floor Distress Inventory (PFDI - 20)
timeFrame: [ Time Frame: 12 months after intervention ]
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
name: Ozan Karadeniz, MD
role: PRINCIPAL_INVESTIGATOR
References: