跳至主要内容
临床试验/NCT01673568
NCT01673568已完成不适用

Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Visual Analog Scale of Pain Activity

研究概览

简要总结

Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact, postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation.

Method and material Randomized, controlled, multi-center, investigator-blinded study. A minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power calculations. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. Outcomes are based on patient self-reported registrations using Visual Analog Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For secondary outcome we use ultrasound to measure the volume of seroma formation. We use Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test for pain, discomfort and quality of life for the effect of time on inter- and intragroup differences during the study period. P < 0.05 is considered significant.

详细描述

Postoperative seroma formation is one of the most common complications after ventral hernia repair. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Several interventional procedures have been investigated to reduce or avoid postoperative seroma formation such as removal of the hernia sac, VAC (vacuum-assisted closure) therapy, talcum application to the subcutaneous layer, suction etc., but results are conflicting and evidence is of poor quality. The use of postoperative abdominal binder is often recommended after ventral hernia repair to prevent seroma and diminish pain, but still with no scientific evidence. Randomized, controlled, multi-center, investigator-blinded study supplemented with blinded statistical analysis (see below). 56 patients (2 x 28, umbi/epi) Due to power calculations. An intention to treat analysis is done. Patients are randomized either to abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company. Patients are followed-up for 30 days with clinical follow-up at day 7 and 30.

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 (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective, primary and recurrent laparoscopic umbilical and epigastric hernia repair with mesh reinforcement
  • Fascia defects 2-8 cm measured preoperatively by the surgeon at the out-patient clinic for umbi/epi
  • Elective, primary and recurrent laparoscopic trocar-site hernia
  • Patients between 18-80 years

排除标准

  • Open ventral hernia repair
  • Expected low compliance (language problems, dementia and abuse etc.)
  • Fascia defects >8 cm at the preoperative clinical examination.
  • Acute operation
  • Chronic pain syndrome
  • Decompensated liver cirrhosis (Child-Pugh B-C)
  • Patients with a stoma
  • If a secondary operation is performed during the hernia repair procedure

结局指标

主要结局

Visual Analog Scale of Pain Activity

时间窗: 24 hours after hernia repair

Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.

次要结局

  • Seroma Formation(postoperative day 7)

研究者

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

Mette Willaume Christoffersen

MD, PhD. stud.

Hvidovre University Hospital

研究点 (2)

Loading locations...

相似试验

Abdominal Binder to Reduce Pain and Seroma Formation | 临床试验