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临床试验/NCT05205213
NCT05205213已完成不适用

Stepwise for the Treatment of Lateral Incisional Hernias

Henares University Hospital1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年2月6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
61
试验地点
1
主要终点
Recurrence

研究概览

简要总结

The best approach for lateral incisional hernia is not known. Posterior component separation (reverse TAR) offers the possibility of using the retromuscular space for medial extension of the challenging preperitoneal plane.

The main objective of the study was to describe the surgical techniques used and their outcomes in the open lateral approach for the treatment of L3-L4 European Hernia Society (EHS) classification Incisional hernias, comparing the results between reverse TAR and pure lateral retromuscular preperitoneal, and analyzing the short- and long- term complications, including patient-reported outcomes measures (PROMs).

The study report followed the recommendations for reporting outcomes in abdominal wall hernias, and the new international classification of abdominal wall planes (ICAP).

A multicenter retrospective observational study was conducted using a prospectively maintained database from three university hospitals in Spain specialized in complex abdominal wall reconstruction. All patients undergoing open abdominal wall repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020 were identified. All patients were operated on by the senior surgeons responsible for the complex abdominal wall units of each participating center. Prior to conducting the study, the approval of the local ethics committee was obtained (ID:39/2019). Written informed consent was also obtained.

The diagnosis of IH was based on clinical examination and imaging from a computed tomography (CT). The investigator only included patients with L3-L4 IHs. Patients with primary lateral hernias, such as Spiegel, Grynfelt and Petit hernias were excluded. We also excluded all patients in which the lateral IH was a parastomal hernia.

Demographic data, patient comorbidities, different classifications of hernia complexity, Carolinas Equation for Determining Associated Risks (CeDAR) and intraoperative and postoperative data were collected All patients followed a similar preoperative optimization program, which included endocrinologic and nutritional evaluations, respiratory physiotherapy, and abstinence from smoking at least 1 month before surgery. Weight loss was extremely recommended but without any mandatory prerequisite.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • •Patients with a lateral incisional hernia L3 European Hernia Society classification
  • •Patients with a lateral incisional hernia L4 European Hernia Society classification
  • •Patients older than 18 years old

排除标准

  • •Midline incisional hernia.
  • •Patients with a parastomal hernia
  • •Patients with a primary midline ventral hernia
  • •Patients with a primary lateral hernia.
  • •Age under 18 years old

结局指标

主要结局

Recurrence

时间窗: At least 12 month

Recurrence was defined as a bulge of the contents of the abdominal cavity or preperitoneal fat through an abdominal wall defect at the site of a previous abdominal wall hernia repair.

次要结局

  • Surgical Site Occurrence(30 days)
  • Bulging(At least 12 month)
  • Surgical Site Occurrence Requiring Procedural Intervention (SSOPI)(30 days)
  • Surgical Site Infection (SSI)(30 days)
  • European Registry for Abdominal Wall Hernias Quality of Life scale ("EuraHS-QoL")(24 months)

研究者

发起方
Henares University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel A ngel Garci-a Urena

Head of General Surgery Service

Henares University Hospital

研究点 (1)

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