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临床试验/NCT01591395
NCT01591395Unknown不适用

Prospective Randomized Trial Comparing the Short-term and Long-term Outcomes of Three-port and Single-port TEP Repair in Adults

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Visual analogue pain score

研究概览

简要总结

Inguinal hernia is one of the most common surgical diseases. Over the past years, the safety and feasibility of laparoscopy was established and gaining popularity in recent few years. Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period, earlier return to normal daily activities and work, and better cosmetic results. The laparoscopic hernia repair usually require three working ports ranging from 5 to 10 mm. However, with each increasing laparoscopic ports usually associated with possible increasing morbidity and pain related to ports.

Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single site surgery. LESS has been performed for variable indications including extirpative and reconstructive urologic procedure via the transperitoneal approach. Early experience has demonstrated the feasibility as well as the safe and successful completion of these LESS procedures. Although these initial reports are promising, the clinical advantages of LESS procedures over conventional laparoscopic procedures have not been defined. Therefore, we conducted a single center, randomized trial to compare the safety and other outcomes after conventional laparoscopic and LESS inguinal hernia repair in adult patients.

详细描述

Inguinal hernia is one of the most common surgical diseases in adult. Tension free hernioplasty is regarded as gold standard of treatment in adult inguinal hernia. The reported incidence of hernia recurrence after tension free repair is less than 5 percent. Over the past years, the safety and feasibility of laparoscopy was established and gaining popularity in recent few years. With the advancing technology, laparoscopic approach has become the standard treatment for cholecystectomy and adrenalectomy. Laparoscopic procedures improved surgical precision through enhanced visualization, magnification and limited exposure, dissection. Laparoscopic inguinal hernia repair was associated with less postoperative pain, a shorter recovery period, earlier return to normal daily activities and work, and better cosmetic results. The laparoscopic hernia repair usually require three working ports ranging from 5 to 10 mm. However, with each increasing laparoscopic ports usually associated with possible increasing morbidity and pain related to ports.

Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery. LESS has been performed for variable indications including extirpative and reconstructive urologic procedure via the transperitoneal approach. Early experience has demonstrated the feasibility as well as the safe and successful completion of these LESS procedures. Although these initial reports are promising, the clinical advantages of LESS procedures over conventional laparoscopic procedures have not been defined.

To date, LESS hernia repair had been rarely reported in the literature except in some case reports and one small series. Although these initial reports revealed that LESS hernia repair is safe and feasible in adult inguinal hernia, the definite clinical benefits of LESS hernia repair could not be identified in these small and short term reports. Thus, a prospective randomized trial comparing LESS and conventional multiport laparoscopic hernia repair with long-term follow up was mandatory to define the clinical advantages of LESS hernia repair. Therefore, we conducted a randomized trial to compare LESS total extraperitoneal hernia repair and conventional multiport TEP repair in adult inguinal hernia with inflammatory, gonadal responses, complication rate and recurrence rate and pain score, functional status and activity level.

Overall Goal

-To compare the surgical outcomes, patient center outcomes and surgery induced inflammatory , gonadal responses after LESS TEP and conventional multiport TEP hernia repair in adult.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary or recurrent inguinal hernia

排除标准

  • previous major lower abdominal surgery, patient refusal of randomization, or unable to accept general anesthesia

结局指标

主要结局

Visual analogue pain score

时间窗: 7 days post-operatively

The pain score was recorded by a blinded observer at the time points of 2 hours post-op, 24 hours post-op and 7 days post-op with a Visual analoge pain scale (0-10 scale)

次要结局

  • modified Medical Outcome Study (MOS)(Post -op 6 months)
  • systemic stress response to surgery(post-operative 1 day)
  • Testicular volume(3 months post-operatively)
  • intervention related complication(6 months post-operatively)

研究者

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

Yao-Chou Tsai, Principle investigator

M.D.

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

研究点 (2)

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