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临床试验/NCT04430816
NCT04430816已完成不适用

Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty, A Comparative Study

Zagazig University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
incidence of skin flap ischemia

研究概览

简要总结

comparison between two groups of large midline incisional hernia, the first group managed by double mesh modification of chevrel's technique the second one managed by conventional onlay mesh repair

详细描述

This comparative study was carried out in general surgery unit, Zagazig university hospitals, between January 2018 and December 2020, on 43 cases with large incisional hernia, participants were randomly allocated according to the deemed option of management into two groups, group A, the modified Chevrel group, 22 participants were treated by double mesh modification of Chevrel's technique, and group B, the on-lay group, participants treated by anatomical repair and fixation of non-absorbable mesh in on-lay position.

inclusion criteria

  • > 18 years old suffering large midline incisional hernia. exclusion criteria
  • complicated incisional hernia,
  • advanced cardiac, respiratory, liver and renal diseases
  • patients with abdominal and abdominal wall malignancy
  • ASA III and IV The study condition is the large midline incisional hernia defined as hernia following mid line incision, its defect is 10 cm or more in any of its diameters.

The main outcome of the study is recurrence of hernia and local complications mainly skin sloughing, seroma formation and wound infection.

All the study participants signed an informed written consent, the study was approved by our local ethical committee and institutional review board All the study participants were subjected to thorough history taking and full systemic and abdominal examination chest X ray, abdomino-pelvic ultrasound examination, measuring of the defect by ultrasound or abdominal CT if needed, preoperative routine laboratory tests, fractionated heparin was given when indicated as a prophylaxis for deep venous thrombosis (BMI >35, previous history of DVT,), they were given third generation cephalosporins just before the induction of anesthesia.

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)

盲法说明

the participants don't know the procedure they will undergo

入排标准

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

入选标准

  • •above 18 years old suffering large midline incisional hernia.

排除标准

  • •complicated incisional hernia,
  • •advanced cardiac, respiratory, liver and renal diseases
  • •patients with abdominal and abdominal wall malignancy
  • •ASA III and IV

研究组 & 干预措施

ON LAY mesh hernioplasty

Active Comparator

21 participant with large midline incisional hernia underwent repair by online mesh hernioplasty

干预措施: on lay mesh hernioplasty (Procedure)

modified chevrel technique

Active Comparator

22 participant with large midline incisional hernia underwent repair by double mesh modification of chevrel's technique

干预措施: double mesh modification of chevrel's technique (Procedure)

结局指标

主要结局

incidence of skin flap ischemia

时间窗: 24 hours postoperative

impaired capillary filling of wound skin flaps , measured by clinical examination (capillary filling time \> 2 seconds)

incidence of seroma formation

时间窗: 24 hours after drain removal

presence of more than 20 ml serous fluid collected around the mesh prosthesis measured by superficial probe ultrasound

incidence of hernia recurrence

时间窗: in the first 2 years post operative

presence of hernia defect of any size in the midline or near it detected by ultrasound or coputerized tomography scan of the anterior abdominal wall

次要结局

  • difference between operative time of both groups(1 day)

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 (1)

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