Clinical trial NCT04178083: Comparison of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy.
Official title: Comparison of Postoperative Results of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy in Patients With Uterine Prolapse.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Laparoscopy
Keywords: laparoscopy
pelvic organ prolapse
modified lateral süspension
pectopexy
sacrohysteropexy
hysteropexy
sacropexy
cervicopexy
sacrocervicopexy
Lead sponsor: Diyarbakir Women's and Children's Diseases Hospital
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent surgical prolapse uteri operation in our 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 .

Eligibility criteria: 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

Primary outcomes:
measure: Anatomical improvement according to POP-Q score
timeFrame: 12 months after intervention
Secondary outcomes:
measure: Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse
timeFrame: 12 months after intervention
measure: Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse
timeFrame: 12 months after intervention
measure: Change from baseline Visual Analog Score (VAS) for pain
timeFrame: 12 months after intervention
measure: Failure (%)
timeFrame: 12 months after intervention
measure: Complications
timeFrame: 12 months after intervention
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Diyarbakır Women's and Children's Hospital
Study officials:
affiliation: Yes
name: Şerif Aksin
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Noe 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.