COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR FOR SEXUAL, SENSORY, LIFE QUALITY AND URINARY FUNCTIONS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Inguinal Region Discrimination Test ( DT)
研究概览
简要总结
The superiority of laparoscopic inguinal hernia surgery over open surgery has been shown in many high patient-numbered studies with early return to work, less pain and good cosmetic results. The aim of this study is to determine the differences between two different methods in terms of sexual, sensory, quality of life and urinary results.
详细描述
Between July 2017 and January 2018, 42 sexually active male patients were randomized with Laparoscopic Total Extraperitoneal (TEP) method and Lichtenstein (LCH) method and repair of inguinal hernia. Patients were evaluated preoperatively, at 1 month and 6 months postoperatively, International Sexual Function Index (IFIF), International Prostatic Symptom Score, SF-36 Quality of Life Scale, Visual Analog Pain Scale, Beck Depression Scale, Inguinal Region Discrimination Test ( DT), DN4 Neuropathic Pain Survey, Uroflowmetry and FSH, LH, Total Testosterone levels were evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral inguinal hernia (diagnosed by physical examination or imaging)
- •Sexual Active
- •Male gender
- •aged between 18 and 65
- •EHS Classification (Primary, lateral or medial, 1 and 2)
排除标准
- •Patients with previous abdominal and inguinal hernia surgery
- •Sexually inactive
- •Emergency patients (Etrangule inguinal hernia)
结局指标
主要结局
Inguinal Region Discrimination Test ( DT)
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Follicle Stimulating Hormone levels
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Beck Depression Scale
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
DN4 Neuropathic Pain Survey
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively. There are 4 questions in this survey and includes totally 10 points in it. Above the 4 points mean it is a neuropathic pain.
International Prostatic Symptom Score
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively. Total 7 questions which are about urinary functions are included.Answers are include 1-5 options. (1:never , 5:always) . Questions are : 1. what is your frequency of feeling that your bladder does not empty after urination 2. what is the frequency of needing to urinate in less than 2 hours after urination? 3. what is your frequency of stopping several times when you urinate and restart? 4. how often do you have difficulty urinating? 5. how often did you feel the reduction in the power of your urine? 6. how often have you experienced difficulty urinating? 7. how many times have you gone to urinate until you get up in the morning?
Total Testosterone levels
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
International Sexual Function Index (IFIF)
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively.Total 15 questions are included.Answers are include 1-5 options. (1:never , 5:always) Question 1,2,3,4,5,15 for erectile function , Question 9,10 for orgasm function , Question 11,12 for sexual desire , Question 6,7,8 for sexual satisfaction , Question 13,14 for general satisfaction.
SF-36 Quality of Life Scale
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Visual Analog Pain Scale
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively.pain scores (VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Uroflowmetry test for urination
时间窗: UP TO 6 MONTHS
In our study, the evaluation of urinary functions was performed with urolowmetry. Patients were evaluated preoperatively, at 1 month and 6 months postoperatively Voiding flow rates and voiding volumes were compared before and after surgery with Uroflowmetry
Luteinising Hormone levels
时间窗: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
次要结局
未报告次要终点
研究者
ANIL ERGIN
Dr Anil ERGIN , General Surgery , Asistant doctor
Fatih Sultan Mehmet Training and Research Hospital