A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
A One-year Follow-up Comparison of Incisional Hernia Formation Between Device Assisted and Manual Closure in Patients Undergoing Elective Laparotomy for Colorectal Diseases
The study compares one-year incisional hernia formation between two cohorts of patients that underwent open surgery for colorectal diseases. The patients had the abdominal wall closure performed with either a device for standardized closure or manual closure.
The devices aims to secure the closure technique that is advocated by guidelines and could potentially reduce abdominal wall complications. Upholding closure quality can be cumbersome and time consuming and hence inferior closure can sometimes be associated with manual closure.
Follow-up will include short term complications like wound infection and burst abdomen and one-year follow-up include a review of patients chart and CTscans performed as part of standard clinical practice.
研究概览
详细说明
This is a single center retrospective study, comparing short and long term abdominal wall related complications among a cohort of 38 patients that underwent abdominal wall closure with a device for standardized laparotomy closure, and a cohort of 180 patients that underwent closure with manual technique during 2020 to 2023.
Included patients were selected for open surgery for colorectal disease according to institutions standard practice. Patients will be identified from a previous study on the device for standardized laparotomy closure and the controls will be identified through the operation administrative system.
Data on short term complications will be retrieved from the patients chart and incisional hernia will be identified by reviewing the CTscans performed as a part of the standard clinical pathway. Reviewing will be performed according to the EHS classification for incisional hernia by two radiologists blinded for the closure technique.
External statistic analysis will be perfromed. Data will be disseminated as a scientific publication.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Skåne County
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Helsingborg、Skåne County、瑞典、251 87
- 招聘中
- Helsingborg Hospital
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接触：
- Gabriel Börner, MD, PhD
- 电话号码：+460704641910
- 邮箱：gabriel.borner@med.lu.se
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接触：
- Marcus Edelhamre, Associated professor
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- >18 years of age
- Patients selected for elective surgical procedure through a midline incision due to colorectal disease
Exclusion Criteria:
- Previous surgery including the midline
- Previous hernia including the midline
- Collagen disease
- Disseminated disease at the time of surgery
- Life expectancy less than 1 year.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Device assisted laparotomy closure
38 patients undergoing elective treatment for colorectal diseases and abdominal wall closure with a device for standardized laparotomy closure
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SutureTOOL is a single patient device for standardized laparotomy closure.
The devices use a 2/0 polydioxanone suture and secures a small-bites closure.
其他名称：
|
|
其他：Manual laparotomy closure
180 patients undergoing elective treatment for colorectal diseases and abdominal wall closure by manual laparotomy closure
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Standard practice of laparotomy closure using standard needle driver and curved needle
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incisional hernia at 1-year
大体时间：1-year
|
Incisional hernia detected by review of CT-scan or clinical examination or chart review revealing incisional hernia.
|
1-year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wound infection
大体时间：30 days
|
Wound infection detected by reviewing patient chart
|
30 days
|
|
Suture length to wound length ratio
大体时间：At the surgical procedure date
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Data collected by reviewing operative notes
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At the surgical procedure date
|
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Wound dehiscence
大体时间：30 days from surgical procedure
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Wound dehiscence detected by review of patient chart.
|
30 days from surgical procedure
|
|
Death due to abdominal wall related complication
大体时间：30 days
|
30 days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Demographic data
大体时间：1 year
|
Demographic data retrieved from patients chart
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Dnr 2026-00853-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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