The Clinical Effects of Intracorporally Closure of the Hernia Defect in Laparoscopic Umbilical or Epigastric Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale
研究概览
简要总结
Introduction: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have sporadically been reported but no evidence is available from randomized controlled trials.
The primary purpose is to compare early postoperative activity-related pain in patients undergoing ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are cosmesis and hernia-related quality of life (QoL) at 30-days and clinical or radiological recurrence and chronic pain after 2 years.
Material and Methods: A randomized, controlled, double-blinded study is planned. Based on power calculation we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at Hvidovre Hospital, Herlev Hospital, or Køge Hospital, who meet the inclusion criteria, are invited to participate.
Conclusion: The technique with closure of the gap may induce more postoperative pain, but may be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Inclusion criteria
- •Elective, primary or recurrent laparoscopic umbilical or epigastric hernia repair, umbilical trocar-site hernia and epigastric hernia repair where laparoscopic hernia repair is no contraindication (i.e. previous laparotomy with anticipated severe and dense adhesions
- •Hernia defect between 2-6 cm measured preoperatively by the surgeon at the out-patient clinic
- •Maximum 1 defect
- •Patients 18-80 years Patients with technical failure (where it is not possible to suture the defect) or patients who are reoperated due to complications remain included and will stay in their primary assigned randomization group in order to perform an intention to treat (ITT) analysis.
排除标准
- •Open hernia repair
- •Poor compliance (language problems, dementia and alcohol or drug abuse etc.)
- •Fascia defect >6 cm (largest diameter, evaluated preoperatively and intra-operatively, thus patients are excluded if the defect is found larger intra-operatively)
- •Emergency repair
- •Chronic pain syndrome (chronic back pain, chronic headache, severe dysmenorrhea, fibromyalgia, whiplash or other conditions requiring daily opioid medication)
- •Daily consumption of opioids (for the last 3 weeks up till the operation)
- •Decompensated liver cirrhosis (Child-Pugh B-C)
- •If the hernia repair is secondarily to another surgical procedure
- •If a patient withdraws his/her inclusion consent
研究组 & 干预措施
sutured closure of the hernia gap
The hernia gap is sutured intracorporally
干预措施: The hernia gap is sutured intracorporally (Procedure)
No closure of the hernia gap
Physiomesh is placed with at least 5 cm overlap of the gap and fixated with double crown technique
结局指标
主要结局
Pain at mobilisation from lying to sitting position measured with Visual Analogue Scale
时间窗: 24 hrs postoperatively
次要结局
- Cosmetic result measured with verbal rating scale and numeric rating scales(measured 30 days postoperatively)
研究者
Mette Willaume Christoffersen
M.D, PhD
Hvidovre University Hospital