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临床试验/NCT07094815
NCT07094815已完成不适用

Comparative Outcomes of Uterus-Preserving and Hysterectomy Approaches in Laparoscopic Lateral Suspension

Havva Betül Bacak1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2025年5月28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
87
试验地点
1
主要终点
Anatomical Success Based on POP-Q System

研究概览

简要总结

This study aims to compare the effectiveness of laparoscopic lateral suspension (LLS) with and without hysterectomy in the treatment of pelvic organ prolapse. Pelvic organ prolapse is a condition that affects many women and can significantly reduce quality of life. Laparoscopic lateral suspension is a minimally invasive surgical technique used to correct this condition. In some cases, the uterus is preserved, while in others, hysterectomy is performed at the same time.

The study retrospectively evaluates patients who underwent laparoscopic lateral suspension, either with or without hysterectomy, at SBÜ Gaziosmanpaşa Training and Research Hospital. Medical records were reviewed to collect information about surgery duration, anatomical success (measured by the POP-Q system), complication rates, blood loss, hospital stay, and recurrence rates.

The goal of this study is to determine whether performing a hysterectomy during laparoscopic lateral suspension has a significant effect on surgical outcomes. The findings may help guide surgical decision-making and improve treatment strategies for women with pelvic organ prolapse.

详细描述

This retrospective cohort study was conducted at SBÜ Gaziosmanpaşa Training and Research Hospital to compare the outcomes of laparoscopic lateral suspension (LLS) with and without concomitant hysterectomy in women with pelvic organ prolapse (POP). POP is a prevalent condition that significantly affects quality of life, and LLS is increasingly performed as a minimally invasive approach that allows either uterine preservation or hysterectomy.

A total of 87 patients treated between 2021 and 2024 were analyzed: 43 underwent LLS with total laparoscopic hysterectomy, and 44 underwent uterus-preserving LLS. Preoperative, intraoperative, and postoperative data were collected from electronic medical records, operative reports, and follow-up documentation, with at least 12 months of follow-up. Outcome measures included POP-Q scores, operative time, blood loss, hospital stay, perioperative complications, recurrence, pelvic pain, and urinary incontinence.

The analysis showed that both groups achieved significant anatomical improvement, with no significant differences in recurrence, pelvic pain, or urinary incontinence. However, hysterectomy was associated with longer operative times, increased blood loss, and longer hospital stays. Vaginal length was better preserved in uterus-preserving procedures. No major intraoperative or postoperative complications occurred.

These findings indicate that adding hysterectomy to LLS increases surgical burden without conferring additional anatomical or functional benefit. Uterus-preserving LLS appears to be a safe and effective option in appropriately selected patients, supporting shared decision-making in pelvic reconstructive surgery.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female patients aged 40 to 80 years
  • •Diagnosis of pelvic organ prolapse (POP) requiring surgical management
  • •Underwent laparoscopic lateral suspension (LLS) with or without concomitant total laparoscopic hysterectomy
  • •Minimum of 12 months postoperative follow-up available
  • •Ability to provide informed consent for use of medical data in this retrospective study

排除标准

  • •History of connective tissue disorders
  • •History of prior pelvic reconstructive surgery
  • •Active pelvic infection or suspected malignancy at the time of surgery
  • •Severe systemic disease that could significantly affect surgical outcomes
  • •Incomplete medical records or missing follow-up data

结局指标

主要结局

Anatomical Success Based on POP-Q System

时间窗: 12 months after surgery

Primary Outcome Title: Number of Participants Achieving Anatomical Success Based on POP-Q System Description: Anatomical success is defined as all assessed POP-Q points (Aa, Ba, C, D, Ap, Bp) being at or above -1 cm (no prolapse extending more than 1 cm below the hymen). POP-Q scale values: Negative values indicate the point is above the hymen (better anatomy), positive values indicate prolapse below the hymen (worse anatomy). Typical range: Aa, Ba, Ap, Bp = -3 to +3 cm; C and D vary according to total vaginal length (TVL). Time Frame: 12 months after surgery

次要结局

未报告次要终点

研究者

发起方
Havva Betül Bacak
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Havva Betül Bacak

M.D

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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