跳至主要内容
临床试验/NCT04960267
NCT04960267Unknown不适用

Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study With Laparoscopic TEP

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Pre-peritoneal Drainage output after rTAPP

研究概览

简要总结

The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.

详细描述

The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.

Criteria of enrolling into trial is same as our previous experiment: aged 18-80, unilateral, first occurrence, reducible, non-inguino-scrotal inguinal hernia fit for GA for minimally invasive hernia repair. Routine robotic TAPP performed in standardized manner and pre-peritoneal drains are placed for drainage of 23 hours post-operatively. Drain output, pain scores, status of seroma formation (clinical, USG detected), post-operative recovery and recurrence will be monitored and compared.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral,
  • First occurrence
  • Reducible inguinal hernia

排除标准

  • Not fit for GA,
  • Bilateral hernia
  • Recurrent hernia
  • Irreducible hernia
  • Inguino-scrotal extension hernia
  • Non-inguinal hernia

结局指标

主要结局

Pre-peritoneal Drainage output after rTAPP

时间窗: at 23 hours post-operation

Pre-peritoneal Drainage output (ml) after rTAPP

次要结局

  • Seroma formation(day 7, 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Joe King-Man Fan

Consultant

The University of Hong Kong

研究点 (1)

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