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临床试验/NCT04166201
NCT04166201已完成不适用

Evaluation of Double Mesh Modification of Chevrel's Technique in Management of Midline Incisional Hernia

Zagazig University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
recurrence of the hernia

研究概览

简要总结

22 patients of incisional hernia underwent treatment by double mesh modification of the original Chevrel's technique the primary outcome was recurrence, skin necrosis secondery out come was pain hematoma seroma

详细描述

This study is a clinical trial carried out on 22 patients with midline incisional hernia, using the double mesh modification of Chevrel's technique, all the procedures were performed by the same group of surgeons.

The exclusion criteria were American Society of Anesthesiologists (ASA) 3, and 4, inflammatory bowel disease, urgent setting, recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer). All patients were informed and consented before recruitment in the study All patients received an intravenous antibiotic prophylaxis with subcutaneous administration of fractionated heparin before surgery when indicated.

Surgical technique All patients were operated on with the double mesh modification of Chevrel's technique. The previous scar was excised then, dissection of the subcutaneous space was performed deep to the neck of the hernia, not wider than 1cm from the edges of the defect, then the sac was opened and resected, the defect size was measured, the skin and subcutaneous tissue was dissected off the anterior rectus sheath only allowing dissection of an anterior rectus sheath flap just sufficient to close the defect without tension After that a bilateral longitudinal incisions was done on the anterior surface of the anterior rectus sheath and a medial anterior rectus sheath flap was dissected off the rectus abdominis muscle, both recti muscles was dissected off the posterior rectus sheath opening the retrorectus space, each of the medial anterior rectus sheath flaps was sutured to that of the other side with slowly absorbed sutures closing the defect without any tension and reforming the posterior rectus sheath

A sizable prolene mesh was fixed with prolene sutures in the retrorectus space spreading between lateral ends of the space and tunneled up 4 cm in the retrorectus space far from vertical edges of the defect,Then the anterior rectus sheath was closed using a prolene mesh tailored to the size of the space between the lateral flaps of both sides and sutured to the edges of the lateral flaps with interrupted non absorbable sutures.

suction drain is left in site, subcutaneous tissue was closed with Vicryl (3\0) , skin was closed with prolene (3\0), drain was removed when the amount of drainage is below 30 ml \ day .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • adult with midline incisional hernia

排除标准

  • (ASA) 3, and 4,
  • inflammatory bowel disease,
  • urgent setting,
  • recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer).

结局指标

主要结局

recurrence of the hernia

时间窗: 2 years

the incisional hernia recurs back measured by clinical examination or abdominal CT

necrosis of the edges of the wound

时间窗: 1 week

gangrene of the medial edges of the midline incision after dissection of the skin and subcutaneous tissue off the rectus sheath measured by clinical examination

次要结局

  • abdominal wall pain(1 year)
  • seroma(1 week)
  • hematoma(1 week)

研究者

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

Hazem Nour Abdellatif

Assistant professor

Zagazig University

研究点 (2)

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