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临床试验/NCT03663959
NCT03663959已完成不适用

Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study

Kocaeli Derince Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2018年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
2
主要终点
Apical descensus relapse rate

研究概览

简要总结

Forty-three women who had vaginal sacrospinous fixations using Dr. Aksakal's Desta suture carrier and 36 women who had laparoscopic pectopexies between January 2014 and June 2018 at H.S.U Kocaeli Derince Training and Research Hospital Gynecology and Obstetrics clinic were re-examined between 15 June and 30 December 2018 gynecologically.

详细描述

Forty-three women who had vaginal sacrospinous fixations using Dr. Aksakal's Desta suture carrier and 36 women who had laparoscopic pectocolpopexies were re-examined 7 to 43 months after surgery. All of the women had undergone surgery for stage 2 or greater uterovaginal or vaginal vault prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.

All of the patients received telephone calls and were invited for a gynecological re-examination. All but one patient in the vaginal surgery group came in for a gynecological control. We conducted a phone interview with the one patient not agreeing to come to the control, and we learned that she had a relapse 6 months after the operation. She underwent another prolapse surgery at a different hospital. She described her postsurgical complaints, and we noted that she was unsatisfied with the surgery. In the postoperative re-evaluation between 15 June and 30 December 2018, all of the women were examined in the lithotomy position for apical, anterior, and posterior compartment descensus. Stage 2 or greater apical descensus or a cystocele or rectocele according to the POP-Q system were accepted as postoperative relapses. All of the patients answered the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and Prolapse Quality of Life (P-QOL) questionnaire. All of the women were asked about de novo urge urinary incontinence and de novo stress urinary incontinence. In addition, each patient's satisfaction with the surgery was asked and recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
45 Years 至 81 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Those patients with stage 2 or greater uterovaginal/vaginal cuff prolapses according to the POP-Q system underwented to surgery (vaginally or laparoscopically) between January 2014 and June 2018 were included to the study.

排除标准

  • Women who had surgeries for malignancy suspicion or pelvic inflammatory disease and women with pectouteropexy procedure were not included into the study.

结局指标

主要结局

Apical descensus relapse rate

时间窗: 7-43 months after surgery

The ratio of women with stage 2 or greater vaginal cuff prolapsus according to the Pelvic Organ Prolapse Quantification (POP-Q) system to all women

次要结局

  • Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)(7-43 months after surgery)
  • Prolapse Quality of Life (P-QOL)(7-43 months after surgery)
  • Satisfied with surgery rate(7-43 months after surgery)
  • De novo central or lateral defect cystocele rate(7-43 months after surgery)
  • De novo rectocele rate(7-43 months after surgery)
  • De novo stress urinary incontinence rate(7-43 months after surgery)
  • De novo urge urinary incontinence rate(7-43 months after surgery)

研究者

发起方
Kocaeli Derince Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

bahar sarıibrahim astepe

obstetrics and gynecology specialist

Kocaeli Derince Education and Research Hospital

研究点 (2)

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