Preoptimisation in Ventral Hernia Surgery- a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 9
- 主要终点
- Complications at three months postoperatively
研究概览
简要总结
The study is a multicentre, single-blinded, randomised controlled trial. Ventral hernia patients with an aperture width between four and eight centimetres are randomised to either participation in a multimodal preoptimisation programme, including interventions to increase physical activity, promote weight loss, and optimise the treatment of comorbidities, or to surgery without structured preoptimisation. The primary endpoint is complications at three months postoperatively. During surgery, biopsies of skin, muscle, and fascia will be collected, along with pre- and postoperative blood samples, to analyse the molecular effects of preoptimisation, particularly in relation to collagen metabolism.
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 (Outcomes Assessor)
盲法说明
The surgeon responsible for the follow-up assessments at 3 and 12 months postoperatively will be blinded to the participant's allocation to either the intervention or the control group.
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 ventral hernia with a defect width of at least 4 cm.
- •Symptom burden related to the hernia sufficient to justify surgical intervention.
- •Age ≥ 18 years.
排除标准
- •Expected survival of less than three years.
- •Inability to comprehend oral and written information or to provide informed consent.
- •Acute complication of the hernia requiring emergency surgical intervention.
- •General condition characterised by severe limitations in physical functional capacity.
结局指标
主要结局
Complications at three months postoperatively
时间窗: 3 months postoperatively
Incidence of surgical and medical (including anaesthetic) complications at 3 months postoperatively.
次要结局
- Complications at twelve months postoperatively(12 months postoperatively)
- Patient-reported pain(Measured at inclusion, preoperatively, 3 and 12 months postoperatively.)
- Weight(Measured at inclusion, preoperatively, 3 and 12 months postoperatively.)
- Collagen metabolism(Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.)
- Quality of life with EQ-5D(Measured at inclusion, preoperatively, 3 and 12 months postoperatively.)
- B-PETH(at baseline, perioperatively and at follow up at 3 and 12 months postoperatively.)
- Rutine labarotory tests(At baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively)
- Aesthetic outcome(Measured at clinical follow-upat 3 and 12 months postoperatively.)
- Change in physical activity(meassured close to inclusion and within a few weeks preoperatively.)
- Hba1c(at baseline, perioperatively, postoperative day 1, at follow up 3 and 12 months postoperatively.)
- Recurrence rate(Measured at clinical follow-up at 3 and 12 months postoperatively.)
- Hernia aperature width(measured peroperatively and on preoperative ct-scan preinclusion or within a few weeks after inclusion)
- Hyaluronan metabolism(Biopsies will be taken perioperatively and thus be avalable for analysis when all study subjects have undergone surgery.)