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NCT04178083 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04178083
Other study ID # DiyarbakirWCDH 2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 30, 2020

Study information
Verified date December 2020
Source Diyarbakir Women's and Children's Diseases Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.)

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 .

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• medical examination
medical examination

Locations
Country Name City State
Turkey Diyarbakir Women's and Children's Hospital Diyarbakir

Sponsors (1)
Lead Sponsor Collaborator
Diyarbakir Women's and Children's Diseases Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bojahr B, Tchartchian G, Waldschmidt M, Ohlinger R, De Wilde RL. Laparoscopic sacropexy: a retrospective analysis of the subjective outcome in 310 cases. Obstet Gynecol Int. 2012;2012:538426. doi: 10.1155/2012/538426. Epub 2011 Sep 7. — View Citation

Noé KG, Schiermeier S, Alkatout I, Anapolski M. Laparoscopic pectopexy: a prospective, randomized, comparative clinical trial of standard laparoscopic sacral colpocervicopexy with the new laparoscopic pectopexy-postoperative results and intermediate-term follow-up in a pilot study. J Endourol. 2015 Feb;29(2):210-5. doi: 10.1089/end.2014.0413. Epub 2014 Nov 20. — View Citation

Veit-Rubin N, Dubuisson JB, Gayet-Ageron A, Lange S, Eperon I, Dubuisson J. Patient satisfaction after laparoscopic lateral suspension with mesh for pelvic organ prolapse: outcome report of a continuous series of 417 patients. Int Urogynecol J. 2017 Nov;28(11):1685-1693. doi: 10.1007/s00192-017-3327-2. Epub 2017 Apr 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Anatomical improvement according to POP-Q score a system for assessing the degree of prolapse of pelvic organs 12 months after intervention
Secondary Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse The survey includes 20 questions grouped in chapters (areas) related to a specific aspect of quality of life 12 months after intervention
Secondary Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse measures the effect of changes in pelvic organ prolapse on quality of life 12 months after intervention
Secondary Change from baseline Visual Analog Score (VAS) for pain Participant describes the pain related to the mesh 12 months after intervention
Secondary Failure (%) Recurrence rate 12 months after intervention
Secondary Complications Injury 12 months after intervention
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