Comparative Evaluation of eTEP (Extended View Total Extraperitoneal) and TEP(Total Extraperitoneal) Techniques in Minimally Invasive Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Patients' Ages
研究概览
简要总结
The enhanced-view totally extraperitoneal (eTEP) technique provides a wider operative field than the conventional totally extraperitoneal (TEP) technique and may facilitate dissection, instrument manipulation, and mesh placement. This study evaluates the potential advantages of eTEP compared with TEP in laparoscopic inguinal hernia repair.
详细描述
The aim of this study was to compare the laparoscopic totally extraperitoneal (TEP) and enhanced-view totally extraperitoneal (eTEP) techniques for inguinal hernia repair. The two techniques were compared in terms of perioperative parameters, postoperative complications, early recurrence, length of hospital stay, postoperative pain, and quality of postoperative recovery. Quality of recovery was assessed using the Turkish version of the 15-item Quality of Recovery questionnaire (QoR-15T), and the outcomes were statistically compared between the TEP and eTEP groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age and patients who agreed to a laparoscopic hernia repair,
- •Unilateral inguinal hernia with fascia defect larger than 0.5 cm,
- •EHS (European Hernia Society) ( Classification (Primary, lateral or medial, 1, 2 and 3)
- •ASA (American Society of Anesthesiologists) 1-3 (not in need of intensive care)
排除标准
- •Strangulated hernias
- •Patients in whom laparoscopic operation is contraindicated,
- •Patients who developed recurrence after TEP or eTEP,
- •Patients with a history of previous open lower abdominal operation
- •Patients who should not receive general anesthesia.
- •ASA 3 patients in need of intensive care and ASA 4 patients
- •Bilateral hernias.
研究组 & 干预措施
The TEP group
one of the techniques used
干预措施: TEP Repair (Procedure)
The eTEP group
one of the techniques used
干预措施: eTEP Repair (Procedure)
结局指标
主要结局
Patients' Ages
时间窗: 1 week
Age in years
Patients' Gender
时间窗: 1 week
Male or Female
Patients' Weight
时间窗: 1 week
Weight in kilograms (kg)
Patients' Height
时间窗: 1 week
Height in meters (m)
Patients' BMI
时间窗: 1 week
BMI in kg/m²
the number of people with Diabetes Mellitus
时间窗: 1 week
determined by numbers of people with Diabetes Mellitus
the number of people with Hypertension
时间窗: 1 week
determined by numbers of people with Hypertension
the number of smoker people
时间窗: 1 week
determined by numbers of smoker people
Side of operation
时间窗: 1 week
Right or Left
the number of people with Direct hernia
时间窗: 1 week
determined by numbers of people with Direct hernia
the number of people with Indirect hernia
时间窗: 1 week
determined by numbers of people with Indirect hernia
the number of people with Direct+ Indirect hernia
时间窗: 1 week
determined by numbers of people with Direct+ Indirect hernia
Defect size
时间窗: 1 week
Defect in centimeters (cm)
Diameter of swelling
时间窗: 1 week
Diameter of swelling in centimeters2 (cm2)
Number of Tacks
时间窗: 1 week
determined by the numbers of tacks used on the patients.
Operation time (min)
时间窗: 1 week
Operation time in minutes (min)
Bleeding
时间窗: 1 week
Bleeding in milliliters (ml)
Analgesic requirement
时间窗: 1 week
1 time or 2 times or 3 times
Duration of hospitalisation
时间窗: 1 week
Duration of hospitalisation in days
Return to work time
时间窗: 1 week
Return to work time in days
次要结局
- Number of Complications(3 months)
- postoperative maximum comfort(3 months)
- postoperative recovery(1 day)
- Postoperative pain(1 week)