Comparison of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy.

Completed

• Conditions: Pelvic Organ Prolapse; Laparoscopy

• Registration Number: NCT04178083
• Lead Sponsor: Diyarbakir Women's and Children's Diseases Hospital

Brief Summary

The aim of this study was to compare the results of laparoscopic sacrohysteropexy, laparoscopic modified lateral suspens9ion and laparoscopic pectopexy between January 2017 and December 2019 in our clinic.(Patients with at least 12 months of the date of surgery will be called for examination.)

Detailed Description

The aim of this study was to compare the results of laparoscopic sacrohysteropexy, laparoscopic modified lateral suspens9ion and laparoscopic pectopexy between January 2017 and December 2019 in our clinic.(Patients with at least 12 months of the date of surgery will be called for examination.)

We will evaluate Pelvic Organ Prolapse Quantitative System (POP-Q), Prolapse Quality of Life Questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS), Visual Analogue Score (VAS), routine gynecologic USG, failure, complication, operation time .

Study Timeline

• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-24
• Study First Posted: 2019-11-26
• Study Start: 2020-01-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Last Update Submitted: 2020-12-31
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• patients requiring surgical treatment for the symptomatic stage of pelvic organ prolapse ≥ 2

Exclusion Criteria

• Age > 70 years
• Severe cardiovascular or respiratory disease
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anatomical improvement according to POP-Q score	12 months after intervention	a system for assessing the degree of prolapse of pelvic organs

Secondary Outcome Measures

Name	Time	Method
Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse	12 months after intervention	The survey includes 20 questions grouped in chapters (areas) related to a specific aspect of quality of life
Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse	12 months after intervention	measures the effect of changes in pelvic organ prolapse on quality of life
Change from baseline Visual Analog Score (VAS) for pain	12 months after intervention	Participant describes the pain related to the mesh
Failure (%)	12 months after intervention	Recurrence rate
Complications	12 months after intervention	İnjury

Trial Locations

Locations (1)

Diyarbakır Women's and Children's Hospital; 🇹🇷 Diyarbakır, Turkey