Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 12:48 AM
Study NCT ID:
NCT03421457
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2018-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Lateral Suspension With Mesh & Sacrocervicopexy for the Treatment of Uterine Prolapse
Sponsor:
Fatih Sultan Mehmet Training and Research Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: