Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- Hernia recurrence rate, with or without surgical repair
研究概览
简要总结
The primary objective of the study is to demonstrate that hernia recurrence (VH) repair with non absorbable mesh concomitant to Bariatric Surgery (BS) decreases the risk of VH, with or without surgical repair, during the first two years after BS when compared to VH suture repair without mesh.
As secondary objectives, the study aims to assess the impact of concomitant VH repair with non absorbable mesh versus suture repair in morbidly obese BS candidates on the following measures: - hernia recurrence at 1 year after randomization; - reoperation for hernia recurrence at 2 years after randomization; - strangulated hernia, surgical infection and mesh bulging at one year after randomization; - postoperative morbidity and mortality at 90 days after randomization; - benefit-risk ratio; - chronic pain at three months, six months, one year and two years after randomization; - quality of life during the two years after randomization; - incremental cost utility ratio; - short- and mid-term weight loss. To study if the efficacy of mesh versus suture VH repair differs according to the type and size of VH and to the surgical technique.
详细描述
This is a prospective, multicentric, superiority, comparative randomized (1:1) single-blinded clinical trial with blinded assessment of the primary endpoint.
Hypothesis for the study: abdominal ventral hernia (VH) repair with mesh during bariatric surgery (BS) is more effective than suture repair in preventing VH recurrence. Secondarily, we expect that mesh repair would not increase the risk of surgical site infection.
Population of study participants:
Patients between 18 and 60 years, presenting with VH and scheduled for BS, excluding pregnant women and protected adults.
All consecutive eligible patients will be invited to participate by visceral surgeons during preoperative consultations for BS. Included patients will be randomly assigned (1/1 ratio) to either mesh VH repair (intervention group) or suture VH repair (control group) by visceral surgeons at hospital admission (hospitalization or outpatient surgery) for BS and VH repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 60 years.
- •Body Mass Index (BMI) ≥ 40 kg/m² or ≥ 35 kg/m² associated with at least one comorbidity that can improve after BS.
- •Body Mass Index (BMI) < 50 kg/m².
- •Primary or first recurrent incisional midline VH, umbilical or epigastric, width between 1 cm and 4 cm, on abdominopelvic CT-scan without contrast injection.
- •Decision for primary sleeve gastrectomy or by-pass after multidisciplinary discussion.
- •Request for BS approved by health insurance authorities.
- •Written informed consent from patient.
排除标准
- •Previous VH repair with mesh.
- •Other types of abdominal hernia (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, and groin hernia).
- •Decision of performing BS by laparotomy.
- •Reoperation for BS (excepted previous adjustable gastric banding).
- •Ongoing abdominal skin infection.
- •Emergency surgery.
- •ASA (American Society of Anesthesiologists) score>
- •Ongoing pregnancy or breast-feeding.
- •Patient not covered by social insurance.
- •Patient under legal guardianship.
- •Patient already included in a clinical trial on hernia recurrence.
结局指标
主要结局
Hernia recurrence rate, with or without surgical repair
时间窗: at 2 years
Final diagnosis of hernia recurrence will be made by an endpoint committee of radiologists, blinded to the randomization arm (it is not possible to distinguish mesh from suture repair on CT-scans) on abdomino-pelvic CT-scan without contrast injection. Radiological hernia is defined as any protrusion of abdominal contents, including the anterior parietal peritoneum, visible as discontinuity of the fascial layers. In case of hernia recurrence requiring new VH repair during the study period (before the two years CT-scan evaluation), this will be considered as an event in intention-to-treat analysis.
次要结局
- Hernia recurrence rate at 2 years(at 2 years)
- Reoperation rate for recurrence at 2 years(at 2 years)
- Weight loss(at 3 months, 6 months, 1 year and 2 years)
- Hernia recurrence rate at 1 year(at 1 year)
- Surgical site infection rate at 1 year(at 1 year)
- Mesh bulging rate at 2 years(at 2 years)
- Postoperative mortality rate(daily up to 90 days)
- Benefit-risk ratio(at the end of the study)
- Strangulated hernia rate at 1 year(at 1 year)
- Postoperative morbidity rate(daily up to 90 days)
- Incremental cost utility ratio(at 2 years)
- Pain evaluation(at 3 months, 6 months, 1 year and 2 years)
- Self-reported chronic pain(at 3 months, 6 months, 1 year and 2 years)
- Score of quality of life(at 3 months, 6 months, 1 year and 2 years)