Evaluation of the Results of Laparoscopic Extraperitoneal ( Modified) Burch
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Preoperative and postoperative UROGENITAL DISTRESS INVENTORY
研究概览
简要总结
Urinary incontinence is a very common problem in women and can be seen at any age. Laparoscopic burch operation has been shown to be an effective, convenient and safe method in women with stress incontinence. Laparoscopic Burch operation is less invasive because it is advantageous in terms of hospitalization time, blood loss, pain and recovery time, but the disadvantage is the procedure time. Modified extraperitoneal technique may be a good method for lowering the procedure time.
详细描述
In the research; The pre- and postoperative urodynamics of patients who underwent laparoscopic extraperitoneal (modified) burch operation in the Gynecology and Obstetrics Clinic of Istanbul Health Sciences University Gaziosmanpasa Training and Research Hospital will be compared. Surgical outcomes together with complications will also be assessed.
In addition, the QUALITY OF LIFE (SF36), which determines the quality of life of the patients related to the urinary system functions, and the UROGENITAL DISTRESS INVENTORY (UDI - 6), INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) questionnaires that determine the effects of urinary incontinence, will be assessed preoperatively and postoperative 6 months of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •having stress urinary incontinence
排除标准
- •having any kind of urogynecological surgery history
- •having pelvic mass
- •having endometrial or myometrial pathology
- •having uterine prolapsus grater than grade 2
- •benign obese
结局指标
主要结局
Preoperative and postoperative UROGENITAL DISTRESS INVENTORY
时间窗: 1 year
Score ranges from zero to 18 and higher scores indicate more severe symptoms and INCONTINENCE IMPACT QUESTIONNAIRE (IIQ-7) in which SCORES RANGES FROM 0 TO 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared.
Preoperative and postoperative Quality of life Questionnaire
时间窗: 1 year
The domains assessed were pain, diet, speech, recreation, anxiety, mood, and overall QoL. Patients were asked to choose a Likert scale response (for example, 1 = no pain to 5 = severe pain) to a question on each domain and higher score represents better health. overall score ranges from 6 to 30. Pre and postoperative values will be compared.
Preoperative and postoperative INCONTINENCE IMPACT QUESTIONNAIRE
时间窗: 1 year
Scores ranges from 0 to 21 AND a higher score indicates more severe symptoms and lower quality of life. Pre and postoperative values will be compared.
Surgical outcomes
时间窗: 1 year
Operation time in minutes
Preoperative and postoperative urodynamic result
时间窗: 1 year
First sensation of fluid filled in bladder in milliliter will be compared.
次要结局
未报告次要终点
研究者
Süleyman Salman
Associate Professor
Gaziosmanpasa Research and Education Hospital