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临床试验/NCT05930795
NCT05930795已完成不适用

Evaluation of the Comparison of Anatomical and Functional Results of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries for the Treatment of Pelvic Organ Prolapse

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2022年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
Comparison of pre and post operative assessment of POP-Q measurements

研究概览

简要总结

There is not a study in the literature comparing laparoscopic pectopexy and laparoscopic lateral suspension (LLS) surgeries in the surgical treatment of pelvic organ prolapse. However, there are studies comparing the efficacy of other surgery types for pelvic organ prolapse. For example,In a study, the clinical and anatomical success rate in LLS operations was 83.8%, while the success rate in abdominal sacropexy operation was 89.2%.In another study in which pectopexy and vaginal sacro spinous fixation operations were compared, apical prolapse recurrence rates were found to be similar in both groups.

详细描述

Pelvic organ prolapse (POP) can be defined as the protrusion of the pelvic organs out of the vagina. Many women experience the symptoms of prolapse of the pelvic organs during their daily activities, during sexual intercourse or during exercise. POP causes various undesirable effects in terms of sexual life and body aesthetics in women. With the increase in the number of elderly individuals in societies, the prevalence of prolapse cases is increasing and is becoming more common.

Patients who had laparoscopic pectopexy operation due to minimum POPQ stage 2 according to the International Classification of Pelvic Organ Prolapse Quantification (POP Q) in our hospital and who had ls lateral suspension surgery with the same indication were planned to be included retrospectively. In the first group, patients who had laparoscopic pectopexy operation were planned to be included. In the second group, it was planned to include patients who had ls lateral suspension operation.

Demographic and intra operative data collected before the procedure: (operation time, estimated blood loss, hospital stay, bowel and bladder injury) and intra operative and postoperative complications and recurrence rates and anatomically preoperative and post op Pelvic prolapse (with POP-Q classification), PopQ values (minimum 6 months) were aimed to be compared between two groups to assess anatomic comparement. Furthermore, the patients will be called back and Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PİS-Q) questionnaire will be applied to both groups and the results will be compared prospectively to assess functional results.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with POP Q stage 2 and above, operated for symptomatic pelvic organ prolapse,
  • Being a Citizen of the Republic of Turkey over the age of 18
  • Patients operated by the same experienced surgeons

排除标准

  • To have received chemotherapy and/or radiotherapy for any reason before
  • Having previously operated for prolapse
  • Cases with Contraindications for Laparoscopy
  • Cases with severe cardiovascular or respiratory disease

结局指标

主要结局

Comparison of pre and post operative assessment of POP-Q measurements

时间窗: 1 year

Comparison of POP-Q values of patients undergone pectopexy and lateral suspension pre and postoperatively.

Comparison of Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire

时间窗: 1 year

Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire will be compared before and after surgery. PISQ- 12 is a Likert type of survey with five options (scoring from 0 to 4) in each question and the patient is asked a total of 12 questions. The total score is calculated by summing points given to each question. A higher score means better sexual function and the highest total score is 48.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Serkan Kumbasar

Principal Investigator

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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