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临床试验/NCT01660048
NCT01660048已完成不适用

Prospective Randomized Single Blind Controlled Study Comparing Single and Multiport Laparoscopic Total Extraperitoneal Inguinal Hernia Repair

The Sydney Hernia Specialists Clinic2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Conversion to multiport or open operation

研究概览

简要总结

Since laparoscopic inguinal hernia was introduced in 1990, it has now become the most commonly performed hernia repair in NSW. Traditionally this is done with 3 small incisions: a 2 cm incision under the navel for insertion of the camera and two 1 cm incisions below the navel for insertion of trocars into which dissecting instruments are inserted to perform the repair. Although this method has been shown to be relatively safe and efficient there are reports of bowel and vascular injuries from the insertion of the smaller trocars which are usually sharp. These can cause serious injuries.

Since 2009, a newer method of performing the key hole repair has been developed. This involves placing a special single port under the navel via a 2-2.5cm incision and into which 3 blunt trocars are inserted. This negates the risks of injuries from sharp trocars. In addition the fact that only a single incision is used this could potentially result in less pain, reduced incidence of wound complications including infection and improved cosmetic results.

However these potential advantages have not been proven in rigorous clinical studies as the single port technique is still relatively new. It is hoped that this study will prove that the single port technique is at least as effective and efficient as the conventional technique in the cure of hernias and may have additional benefits as enumerated above.

Neither you nor your surgeon will know which procedure (three port or single port hernia repair) until you are already asleep in the operating room and a random number selecting process will automatically assign you to one procedure or the other. Sometimes it is not possible to perform the single port safely in which case your procedure will be converted to a three ports procedure.

All patients having surgical treatment of groin hernia at Holroyd Private Hospital are subject to very careful assessment and study. All patients are requested to report immediately if there are any problems. Any problems would normally be reported to your treating surgeon who has primary responsibility for your care. Problems can be reported directly to Holroyd Private Hospital. Any information in your medical records is subject to stringent confidentiality requirements. The hospital is bound by the Australian Privacy Council Charter as regards confidentiality and privacy.

详细描述

This study will compare the Laparoscopic TEP repair of inguinal/femoral hernias using the traditional three ports and the newer single port techniques.

Laparoscopic hernia repair was first introduced in 1990. The uptake rate was slow to start off with such that in 1994 only 9.7% of all inguinal hernias were performed laparoscopically However, in 2009, the figure now stands at 40% Australia-wide. (www.medicareaustralia.gov.au). Indeed, in NSW this figure stands at 48%, which means that it is the commonest operation performed for inguinal hernias in this State.

Up to 2009, the laparoscopic hernia repair involves the insertion of 3 ports: 10mm port in the infra-umbilical region for the camera via a 2 cm incision and 2 x 5mm working ports usually in the midline for the dissecting instruments via 2 x 10mm incisions. These ports are called secondary trocars which are usually sharp. Their insertion has the potential to cause bowel and vascular injuries.

The European Hernia Society guidelines (www.herniaweb.org) on the treatment of inguinal hernias have shown (conventional) endoscopic techniques to be associated with higher rates of port-site hernias and visceral injuries especially during the learning curve period.

A recent study of 37,000 gynaecological laparoscopies in the US showed a bowel injury rate of 0.16%; a third of these led to the death of the patients. 22% of all bowel injuries resulted from the insertion of secondary trocars (www.danaise.com/vascular\_and\_bowel\_injuries\_duri.htm).

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
Single (Participant)

入排标准

年龄范围
16 Years 至 86 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all referred patients with inguinal hernias

排除标准

  • workers Compensation cases
  • previous extraperitoneal intervention
  • unfit for a general anaesthetic
  • strangulated hernias
  • present of or previous ventral hernia repair extending 5 cm below umbilicus

研究组 & 干预措施

SILS TEP repair

Experimental

Half of the patients will undergo laparoscopic total extraperitoneal inguinal hernia repair using a single port (Triport)

干预措施: Total extraperitoneal inguinal hernia repair (Procedure)

SILS TEP repair

Experimental

Half of the patients will undergo laparoscopic total extraperitoneal inguinal hernia repair using a single port (Triport)

干预措施: SILS TEP repair (Procedure)

Multiports TEP repair

Active Comparator

Half of the patients will undergo the conventional multiports total extraperitoneal inguinal hernia repair

干预措施: Total extraperitoneal inguinal hernia repair (Procedure)

结局指标

主要结局

Conversion to multiport or open operation

时间窗: during operation

This refers to whether any single port procedure needs to be converted to multiports or open procedure. This is quite a normal process as a proportion of multiport procedures are converted to open procedures for safety reasons.

次要结局

  • Length of hospital stay(day procedure or overnight stay)
  • Cosmetic scar score(6 weeks)
  • Analgesic requirements(one week)
  • Operating time(during operation)
  • return to work or normal physical activities(6 weeks)
  • Recurrence of hernia(1 year)
  • Pre and post operative pain scores(preop, day one and day 7 postop)
  • Quality of life health scores(preop, 6 weeks and 1 year postop)
  • post-operative complications including urinary retention, wound infection, seroma formation, chronic pain, testicular atrophy(6 weeks)

研究者

发起方
The Sydney Hernia Specialists Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Hanh Minh Tran

Director

The Sydney Hernia Specialists Clinic

研究点 (2)

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