跳至主要内容
临床试验/NCT02293369
NCT02293369已完成不适用

Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy and Their Effect on Female Sexual Function and Vaginal Length

Istanbul University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Female Sexual Function

研究概览

简要总结

American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs.

Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.

Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only

排除标准

  • Suspicion of malignancy
  • Presence of large adnexal masses (maximum diameter >10 cm at preoperative ultrasonography)

结局指标

主要结局

Female Sexual Function

时间窗: Three months

Patients will be asked to fill out female sexual function index (FSFI) prior to surgery and at the 3-month follow-up.

Vaginal length

时间窗: One months

Vaginal measure will be taken prior to surgery and at 1-month follow-up.

次要结局

  • Vaginal cuff granulation/infection(One month)
  • Vaginal cuff closure time(One day)

研究者

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

Ercan Bastu

Associate Professor of Obstetrics and Gynecology

Istanbul University

研究点 (2)

Loading locations...

相似试验