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临床试验/NCT06858020
NCT06858020招募中不适用

NoPro - Norwegian Hernia Prophylaxis Study: Onlay Mesh Versus Small Bite Suture Technique Closure of Midline Laparotomies

Sykehuset Innlandet HF1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年2月17日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Incisional hernia

研究概览

简要总结

A multicenter randomized controlled trial comparing midline laparotomy closures using the small-bite suture technique alone to those using the small-bite suture technique with an additional onlay prophylactic polypropylene mesh. The primary endpoint is the incidence of incisional hernias in both groups after one year.

详细描述

An incisional hernia (IH) is a defect in the abdominal wall at the site of a surgical scar, leading to the protrusion of abdominal contents through the defect. It is a common complication following midline laparotomy, with incidence rates ranging from 9% to 40% in the general population, and up to 69% in high-risk patients. Several studies have been conducted on the prevention of IH, and one established intervention is the use of a synthetic mesh to reinforce the suture closure of the abdomen after midline laparotomy. However, the use of mesh in this context is not widespread in Norway, and there are no Norwegian studies on IH prevention following midline laparotomy. This study aims to contribute to the broader knowledge base and encourage Norwegian surgeons to consider using prophylactic meshes.

The study will involve three Norwegian hospitals: Hamar Hospital, Gjøvik Hospital, and Lillehammer Hospital. Participants will be patients scheduled for midline laparotomy at these hospitals who consent to participate, meet the inclusion criteria, and do not meet any exclusion criteria. Participants will be randomly assigned to two groups, each receiving a different variation of fascia closure during laparotomy. One group will undergo closure using the standard small-bites technique only, while the other group will undergo closure with the small-bites technique in addition to an onlay polypropylene mesh.

The primary outcome is the occurrence of incisional hernia one year after surgery, identified through clinical examination and CT scan. Additionally, surgical site occurrences (e.g., hematoma, infection, seroma, wound dehiscence) will be recorded four to six weeks post-surgery. Quality of life and pain levels will also be assessed at both four to six weeks and one year after surgery.

研究设计

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

盲法说明

The radiologists who interpret the CT scans after 12 months evaluating if the patient has developed an incisional hernia

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

  • Surgery predominantly done my midline laparotomy
  • Age 18 years old or older
  • Written consent by patient/family
  • Midline laparotomy with delayed closure

排除标准

  • Exclusion Criteria:
  • Age under 18 years
  • Pregnancy
  • Previous abdominal midline hernia mesh repair
  • Abdominal compartment syndrome
  • Linea alba closure not possible
  • Life expectancy under six months
  • Hernia in the midline with transverse diameter lager than 2 cm

结局指标

主要结局

Incisional hernia

时间窗: 12 months

Incisional hernia occurrence will be evaluated clinically and by CT examination after 12 months

次要结局

  • Quality of Life(4-6 weeks and 1 year)
  • Level of pain(4-6 weeks and 1 year)
  • Symptomatic surgical site occurrence (SSO)(4-6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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