跳至主要内容
临床试验/NCT02415543
NCT02415543Unknown不适用

A Prospective, Randomized, Controlled Trial of Comparing Single Incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair With Traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in Day Surgery

TAO CHEN1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
SIL-TEP Conversion to TEP / TAPP or open operation

研究概览

简要总结

This study aim to compare the efficacy and safety of Single incisional Laparoscopic Total Extraperitoneal(SIL-TEP) Inguinal Hernia Repair and traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in day surgery. This study also aim to improve the surgical-related technical details and the device design.

In addition, this study also evaluate the operability of SIL-TEP in term of a day surgery item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the SIL-TEP technology in the investigators country.

详细描述

This is a prospective, randomized,controlled trail. It compared Single Incisional Laparoscopic Total Extraperitonea(SIL-TEP) with traditional Laparoscopic Total Extraperitoneal(TEP) Inguinal Hernia Repair in condition of day surgery.

Laparoscopic hernia repair technique including two tyes, TEP and TAPP, which were recognized as mordern minimally invasive technique. Laparoscopic hernia repair were recommended by the Association of Surgeons of Great Britain and Ireland (ASGBI) and European Hernia Society Guideline (EHS) as the first choice for primary inguinal hernia. Compared with TAPP, TEP was performed much more frequently for its advantages of avoiding abdominal visceral injury.

Traditional TEP hernia repair involves 3-port insertions: one incision of 2cm in para-umbilical region for the camera and two smaller incisions of 5mm each in the midline for the surgical instruments. Some surgeons think the second and third ports could led to bowel and bladder injury. Early literatures showed that bowel injuries and bladder injuries were observed in TAPP or TEP hernia repair.

Since 2009, Cugura JF and Filipovic-Cugura J led their teams for a preliminary exploration of SIL-TEP. Later, several cases were reported about this surgical technique globally. Since then, a number of retrospective studies about the comparation of SIL-TEP and traditional TEP were carried. Yang GP et al found that SIL-TEP had a longer operation time than traditional TEP, but in terms of postoperative complications and incision aesthetics. Tu Wenbin et al thought that SIL-TEP was effective and also had advantages in postoperative pain, postoperative complications and time in hospital. Several other reports also had similiar opnions.

However, randomized controlled trial related to this suject is quite limited. Our study aim to compare the efficacy and safety of SIL-TEP and traditional TEP surgery with a RCT design and also aim to improve the surgical-related technical details and the device design. Our study also evaluate the operability of SIL-TEP in term of a day surgery item and try to provide the basis for SIL-TEP day surgery guildline, so as to promote the SIL-TEP technology in our country.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed of primary unilateral inguinal hernia and age between 18 and 70 ;
  • Good condition of family care and observation, understand and be willing to accept day surgery mode;
  • Willing to participate in this study and signed an informed consent.

排除标准

  • Diagnosed as femoral hernia, recurrent hernia, scrotal hernia, bilateral hernia and strangulated hernia;
  • Patients with severe chronic diseases or cardiopulmonary dysfunction;
  • American Society of Anesthesiologists (ASA) grade III and IV level;
  • Obese patients ( BMI> 30 );
  • Patients with a history of lower abdominal surgery;
  • prefer to a centain surgical approach.

结局指标

主要结局

SIL-TEP Conversion to TEP / TAPP or open operation

时间窗: during operation

This refers to whether any SIL-TEP procedure needs to be converted to TEP/TAPP 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(1 day postoperation)
  • return to work or normal physical activities(4 weeks postoperation)
  • Cosmetic scar score(4 weeks)
  • Operating time(during operation)
  • post-operative complications including urinary retention, wound infection, wound haematoma,seroma formation, chronic pain, testicular atrophy(1 week, 4 weeks after postoperation)
  • interoperation complication(during operation)
  • Pain score (Visual Analog Scale) at 12、24 hour and one week after surgery(12、24hour and day 7 postoperation)
  • Recurrence of hernia(4 weeks,3 mounths and 1 year postoperation)
  • hospitalization costs(1 day postopetation)

研究者

发起方
TAO CHEN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

TAO CHEN

attending doctor

RenJi Hospital

研究点 (1)

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