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临床试验/NCT02762747
NCT02762747Unknown不适用

Pre-peritoneal Drainage Versus No Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia - a Randomised Controlled Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Seroma formation after TEP hernioplasty

研究概览

简要总结

This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. Other secondary outcomes will be measured including post-operative pain, discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.

详细描述

Inguinal hernia is a common disease and causes significant morbidity if left untreated. With the advances of laparoscopic approach of extra-peritoneal hernioplasty, it significantly reduces the post-operative pain and lead to a better quality of life with higher acceptance to patients.However, similar to traditional Litchenstein approach, post operative seroma formation is still a common problem encountered after surgery. Numerous method has been described to reduce chance of seroma formation, however, none was proven to be effective except pre-peritoneal drainage. There are currently 2 large retrospective non-randomized cohort study to evaluate the effectiveness of preperitoneal drainage available for reference. We therefore study the feasibility and efficacy of preperitoneal drainage with large scale randomized trial.

Patient fulfill inclusion criteria and consent to surgery and study will be recruited. A standardized pre-peritoneal dissection and mesh placement will be adopted. Immediately before deflation of pre-peritoneal space, randomization will be performed by calling research assistant for study group using computer generated code. Drain will be placed for 23 hours after operation and ultrasonography will be performed immediately after removal of drain. USG will be repeated at post-operative 1 week, 1 month, 3 months, 6 months and 1 year after surgery. For non-drain group, a fake drain will be attach to the skin of the wound to achieve double blinding to patients and assessors. In addition to seroma, patient demographics and secondary outcome including post-operative pain score, discomfort, foreign body sensation, patient satisfaction, infection, recurrence, etc will be studied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Age above 18 and below 80
  • 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
  • Co-morbidies
  • Decline or not consent to surgery

结局指标

主要结局

Seroma formation after TEP hernioplasty

时间窗: post-operative 1 year

Seroma will be assessed clinically by independent assessor who is blind to the group assigned and also by qualified radiologist who will perform USG to measure the exact size of seroma formation after TEP

次要结局

  • Post-operative pain after TEP hernioplasty(post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year)
  • Analgesic used after after TEP hernioplasty(post-operative day 1 to day 7, 1 month, 3 month, 6 month, 1 year)
  • Hernia recurrence after TEP hernioplasty(post-operative 1 month, 3 month, 6 month, 1 year)
  • Chronic discomfort after TEP hernioplasty(post-operative 1 month, 3 month, 6 month, 1 year)
  • Patient satisfaction after TEP hernioplasty(post-operative 1 month, 3 month, 6 month, 1 year)

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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