Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair

Kanuni Sultan Suleyman Training and Research Hospital

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: LLS versus LP

Study type: Interventional

Funder types: Other

Identifiers

NCT05143658

KanuniSSS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Laparoscopic Lateral Suspension Group (LLS)

Active Comparator group

Description:

Anterior and apical prolapse repair via LLS

Treatment:

Procedure: LLS versus LP

Laparoscopic Pectopexy (LP)

Experimental group

Description:

Anterior and apical prolapse repair via LP

Treatment:

Procedure: LLS versus LP