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临床试验/NCT01240434
NCT01240434已完成不适用

Estudio Prospectivo Aleatorizado Simple Ciego Sobre la Incidencia de Hernias Incisionales en Los Orificios de Los trócares de Laparoscopia: Cierre aponeurótico Superficial Frente a cicatrización aponeurótica Sin Cierre

Hospital General Universitario Gregorio Marañon2 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2006年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
195
试验地点
2
主要终点
The incidence of trocar site hernia

研究概览

简要总结

The investigators perform a simple-blind randomized trial with two groups, one in which all the orifices are closed by suturing the external fascia of the abdominal wall (Group A), and another in which the orifices are left open, closing only the skin (Group B). Monitoring for trocar site hernia lasted 2 years from the intervention.

详细描述

This is a single-blind trial including all patients undergoing laparoscopic surgery performed by the same surgical team (5 surgeons) and for whom at least one "study trocar" (ST) id use. STs is define as blunt-tip trocars that are inserted blind, had a diameter of 11 mm or 12 mm, and are not enlarged during surgery. The investigators have not studied the Hasson trocar, as the defect it creates is surgeon-dependent and not uniform.

The investigators exclude patients presenting factors that affect the scarring process, such as malnutrition (serum proteins <5 g/dl), advanced cancer, perioperative hemodynamic instability, or prolonged treatment with corticosteroids. Orifices that are enlarged for specimen extraction are also excluded, although other orifices in the same patient are included.

The investigators exclude the following patients: those who are converted to open surgery, those who underwent a second intervention with an open technique during the early postoperative period, or those who are lost to follow-up. Patients who hace not an ST after surgery (mostly patients with only one ST that have to be enlarged for specimen extraction) are excluded from the trial.

The investigators randomize patients using a random table from Excel® for Windows XP®.

The trocars that the investigators use are Endopath Xcel (Ethicon Endo-Surgery, Puerto Rico, USA), which are 11 mm and 12 mm in diameter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • All the patients undergoing laparoscopic surgery performed by the same surgical team (5 surgeons) and for whom at least one "study trocar" (ST) is used. STs is defined as blunt-tip trocars that are inserted blind, had a diameter of 11 mm or 12 mm, and are not enlarged during surgery.

排除标准

  • Hasson trocar Patients presenting factors that affect the scarring process, such as malnutrition (serum proteins <5 g/dl), advanced cancer, perioperative hemodynamic instability, or prolonged treatment with corticosteroids. Orifices that are enlarged for specimen extraction are also excluded, although other orifices in the same patient are included.
  • Patients who are converted to open surgery. Patients who did not have an ST after surgery (mostly patients with only one ST that had to be enlarged for specimen extraction) were excluded from the trial.

结局指标

主要结局

The incidence of trocar site hernia

次要结局

  • The incidence of wound infections

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other

研究点 (2)

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