A Prospective Randomized Pilot Study Comparing Transabdominal Properitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Laparoscopic Inguinal Hernioplasty in Recurrent Inguinal Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The purpose of this study was to compare between laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair of inguinal hernia in recurrent inguinal hernia.
详细描述
The primary objective in this study was to compare postoperative pain between the TAPP group and the TEP group. The secondary objective was to compare operative time, intraoperative complications (bleeding, bowel injury, vascular injury), postoperative complications (hematoma, seroma, wound infection), length of hospital stay and recurrence rate with possible risk factors which include gender, age, BMI ,cord lipomas and location of the hernia.
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
- Double (Participant, Care Provider)
盲法说明
Each patient was randomly allocated to the TAPP group or the TEP group by sequentially numbered, opaque , sealed envelope (SNOSE) technique on the day of surgery. An independent statistician , who was not involved in patient care, generated the randomization sequence via a computer generated random number. The randomization code was contained in opaque sealed envelopes. A junior resident , who opened the envelope , was not actively involved in outcome measurements .Before randomization and during the consent, all patients received an explanation of the objectives of the study, techniques and complications associated with both procedures.
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
- •Patients diagnosed with unilateral or bilateral recurrent inguinal hernias.
- •Patients between 18 and 70 years old
- •Fit for anesthesia.
- •Agree to participate in the study
- •Both genders were included.
排除标准
- •Unfitness for general anesthesia and operation.
- •Age < 18 years or >70 years.
- •Complicated hernias (acute irreducible, obstruction or strangulation).
- •The presence of mental or psychological disorders.
- •Refusal to participate in the study.
结局指标
主要结局
Postoperative pain
时间窗: 6 months
by use of visual analog scale (VAS) where (0) refereed to no pain and (10) refereed to the severest pain.
次要结局
- operative time(6 months)
- complications(6 months)
研究者
Islam Hisham
Principal Investigator
Mansoura University