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Completed

NCT Number: NCT04178083

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

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.)

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Key information

Conditions

Pelvic Organ Prolapse Laparoscopy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Diyarbakır Women's and Children's Hospital

Diyarbakır, 21100, Turkey (Türkiye)

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical examination

Diagnostic Test

medical examination

Other names: Routine gynecological examination for POP-Q

Primary outcomes

  1. Anatomical improvement according to POP-Q score

    Time frame: 12 months after intervention

    a system for assessing the degree of prolapse of pelvic organs

Secondary outcomes

  1. Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse

    Time frame: 12 months after intervention

    The survey includes 20 questions grouped in chapters (areas) related to a specific aspect of quality of life

  2. Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse

    Time frame: 12 months after intervention

    measures the effect of changes in pelvic organ prolapse on quality of life

  3. Change from baseline Visual Analog Score (VAS) for pain

    Time frame: 12 months after intervention

    Participant describes the pain related to the mesh

  4. Failure (%)

    Time frame: 12 months after intervention

    Recurrence rate

  5. Complications

    Time frame: 12 months after intervention

    İnjury

Sponsors and collaborators

Lead sponsor

Diyarbakir Women's and Children's Diseases Hospital

Other

Registry information

Official study title

Comparison of Postoperative Results of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy in Patients With Uterine Prolapse.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2019
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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