Laparoscopic Lateral Suspension With Mesh & Sacrocervicopexy for the Treatment of Uterine Prolapse

Fatih Sultan Mehmet Training and Research Hospital

Status: Completed

Conditions: Pelvic Floor Prolapse; Pelvic Organ Prolapse

Treatments: Procedure: Uterus-preserving laparoscopic sacrocervicopexy with mesh; Procedure: Uterus-preserving laparoscopic lateral suspension with mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03421457

RCTPOPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Lateral suspension

Experimental group

Description:

"Uterus-preserving Laparoscopic lateral suspension with mesh" technique will be performed in this arm.

Treatment:

Procedure: Uterus-preserving laparoscopic lateral suspension with mesh

Sacrocervicopexy

Experimental group

Description:

"Uterus-preserving Laparoscopic sacrocervicopexy with mesh" technique will be performed in this arm.

Treatment:

Procedure: Uterus-preserving laparoscopic sacrocervicopexy with mesh