Randomised Controlled Trial on Use of Monopolar Energy Versus Blunt Dissection in Totally Extra-peritoneal Hernioplasty (TEP) for Inguinal Hernia - the Effect on the Output of Pre-peritoneal Drain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Drain output at 23 hours post-operation
研究概览
简要总结
There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.
详细描述
There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.
all male and female patients presented with first occurrence, unilateral inguinal hernia anticipated for laparoscopic TEP are included into study after informed consent. Patients are randomized into "diathermy-preferred" (DP) group and "blunt dissection-preferred" (BDP) group just before commence of operation after general anaethesia. Surgeons are instructed to use monopolar energy as main dissection method for whole operation if possible (DP), where as blunt dissection is the preferred choice in BDP group but it is allowed to use monopolar energy if needed. Total energy time is measured by a specially designed device attaching to the monopolar pedals as accurate as to millisecond (ms). Pre-peritoneal drains are inserted for drainage and removed 23 hours after operation. Energy time, drainage output, ultrasonic seroma sizes at day 1, day 6, 1 month post-operations, recurrence are compared between 2 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, Investigator, Outcomes Assessor)
盲法说明
Patients, assessors and investigators will be blinded on patient group.
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 and below 90
- •Male or female patients
- •Unilateral inguinal hernia
- •First occurrence hernia
- •Consent to laparoscopic hernioplasty for inguinal hernia
排除标准
- •inguino-scrotal hernia
- •Recurrent inguinal hernia
- •Incarcerated hernia
- •Bilateral inguinal hernia
- •Bleeding tendency
- •On anti-platelet agent or anti-coagulant
- •Significant co-morbidies
- •Patients with pacemaker
- •Decline or not consent to
结局指标
主要结局
Drain output at 23 hours post-operation
时间窗: 23 hours post operation
pre-peritoneal drain output (in ml) at 23 hours post-operation
次要结局
- Seroma at 23 hours post-operation(23 hours post operation)
- Pain score at first week(1 week)
- Seroma at 1 week post-operation(1 week post operation)
- Seroma at 1 month post-operation(1 month post-operation)
研究者
Dr. Joe King-Man Fan
Honorary Consultant
The University of Hong Kong
