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临床试验/NCT00687375
NCT00687375Unknown不适用

A Randomized Controlled Trial of Laparoscopic Inguinal Hernia Repair- Transabdominal Preperitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Approach

All India Institute of Medical Sciences, New Delhi2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2007年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Operating time (in minutes)

研究概览

简要总结

Laparoscopic inguinal hernia repair (LIHR) has got comparable results in comparison to open hernia repair (OHR). Many studies have shown that LIHR gives similar results in terms of recurrence as compared with OHR but with the added advantage of less chances of post operative, pain, wound infection and early return to activity. LIHR was started using the transabdominal preperitoneal (TAPP) approach. Another technique of LIHR that has evolved is totally extra peritoneal (TEP) repair. There is only one study of 52 patients comparing TAPP with TEP repair and thus there is insufficient information as to which of the 2 techniques is better. Therefore, we have designed the present study to compare the transabdominal preperitoneal (TAPP) technique with totally extra peritoneal (TEP) technique of laparoscopic inguinal hernia repair. The advantages of TEP may include - no breach of peritoneum so less risk of bowel injury and post-operative adhesions. We will be using a modified technique of TEP repair where we will not use tacker to fix the mesh to reduce the cost of the procedure. On the other hand, TAPP is easy to perform and probably better for irreducible hernia. There is no such comparative study reported in the literature. We have been performing both TAPP and TEP procedures for hernia repair regularly in the department.

RESEARCH HYPOTHESIS: TEP repair of inguinal hernia is better than TAPP repair in terms of reduced cost and avoidance of peritoneal incision.

OBJECTIVE: To compare the Transabdominal preperitoneal (TAPP) vs. Totally extra peritoneal (TEP) techniques of laparoscopic inguinal hernia repair.

详细描述

The following information from the literature was obtained by searching through the MEDLAR and PUBMED using the key words 'TAPP', 'TEP', 'Laparoscopy' and 'Inguinal hernia'.

Application of laparoscopic techniques has revolutionized the field of surgery. General surgeons have accepted laparoscopic surgery unequivocally. Few would dispute the tremendous success and the impact that laparoscopic cholecystectomy had on the management of gallstone.1 Laparoscopic inguinal hernia repair (LIHR) was introduced following the success of laparoscopic cholecystectomy on the premise that there would be less post-operative discomfort and pain, repair of recurrent hernias would be easier and bilateral hernia can be treated concurrently with improved cosmesis. Ger and Associates2 reported first laparoscopic inguinal hernia repair. Schultz et al3 were the first to report the use of prosthetic material during laparoscopic inguinal hernia repair.

LIHR has got comparable results in comparison to tension free open hernia repair (OHR). Many studies have shown that LIHR gives similar results in terms of recurrence as compared with OHR but with the added advantage of less chances of post operative, pain, wound infection and early return to activity4-6.

Laparoscopic inguinal human repair has undergone tremendous change since its introduction in 1990 by Ger et al3. LIHR was started using the transabdominal preperitoneal (TAPP) approach. TAPP repair involves formation of a peritoneal flap and placement of a mesh in the preperitoneal space. The mesh is then held in place using a tacker. Initially, TAPP became the commonly performed laparoscopic procedure and a number of studies demonstrated the efficacy of TAPP and its comparable results with tension free OHR4-7. Arvidasson D et al8 compared 5 years recurrence rates of laparoscopic inguinal hernia repair Vs. Shouldice repair of primary inguinal hernia which is considered the gold standard for open non-mesh repair of hernia. The cumulative recurrence rate after 5 years was 6.6% in the TAPP group and 6.7% in the Shouldice group. Thus, the TAPP operation represents an excellent alternative to primary inguinal repair.

Wara et al9 have demonstrated that laparoscopic repair compared favourably with Lichteinstein repair for primary indirect and direct hernias, unilateral and bilateral hernias, and recurrent hernias but was inferior for primary bilateral hernias.

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
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

  • All consecutive patients with uncomplicated symptomatic inguinal hernia attending the out patient department of surgery at AIIMS will be included in the study.
  • The diagnosis of inguinal hernia will be made clinically.

排除标准

  • Co-morbid conditions making the patients unfit for general anaesthesia
  • Complicated hernia.
  • Uncorrectable coagulopathy
  • Morbid obesity (Body Mass Index > 30)
  • Suspected intra-abdominal or pelvic malignancy.

结局指标

主要结局

Operating time (in minutes)

时间窗: Two years

Cost of the procedure

时间窗: Two years

次要结局

  • Conversion rate(Two years)
  • Recurrence of hernia(Two years)
  • Major complications(Two years)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other

研究点 (2)

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