ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a
研究概览
简要总结
This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.
The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.
The main questions it aims to answer are:
- pain after the operation
- rate of complications
- rate of recurrence and reoperations
- quality of life.
Participants will:
Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The trial participants and the assessors (trained investigators not involved in the operative procedures) of the primary outcome are blinded regarding the performed procedure during the first seven days after the procedure to reduce bias. The blinding is guaranteed by not sharing the detailed operation report with anyone involved in the aftercare of the patient or in the assessment of study outcomes.
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
- •Patient age >18 years
- •Informed consent obtained
- •Primary or incisional ventral hernia
- •Epigastric, umbilical or infraumbilical ventral hernias with transversal diameter >1cm and </= 4cm, +/- rectus diastasis which doesn't demand specific treatment
- •If multiple hernias: cumulative transversal diameter </= 4cm
- •Considered eligible for minimally-invasive approach
排除标准
- •Subxyphoidal or suprapubic hernias
- •precedent hernia treatment with mesh placement in the retromuscular space
- •liver disease defined by the presence of ascites
- •end-stage renal disease requiring dialysis
- •need of an emergency surgery
- •pregnancy
- •need of rectus diastasis treatment intraoperatively
- •Criteria for participating surgeons
- •- Each participating surgeon has performed 20 or more laparoscopic IPOM procedures and 20 or more eTEP procedures.
研究组 & 干预措施
eTEP (Extended totally extraperitoneal repair)
The anterior rectus sheath is incised and the retromuscular space is entered through the rectus muscle fibres. The capnopreperitoneum is established and blunt dissection of the retromuscular space is performed. Two additional laparoscopic ports are established 8-10cm lateral to the linea alba caudally to the initial port. The medial border of the rectus sheath is incised and the preperitoneal space below the linea alba is dissected. The hernia orifice is also dissected from peritoneum and preperitoneal fatty tissue. The medial border of the right retromuscular space is then incised and blunt dissection is performed. The hernia orifice is closed with barbed suture and a synthetic mesh is placed on the posterior sheath of the dissected space (intended Mesh-defect ratio 16). The mesh is fixed non-traumatically using glubran glue or no fixation at all.
干预措施: Extended totally extraperitoneal repair (Procedure)
IPOM (intraperitoneal onlay mesh)
Capnoperitoneum is established through left sided subcostal Veress-Needle punction. Three laparoscopic ports are placed 8-10cm lateral to the linea alba usually on the patient's left side. The peritoneum is incised and detached from the umbilical and supraumbilical linea alba. The peritoneum including the hernia sac and preperitoneal fat is resected. The hernia orifice is then closed using a barbed suture. A coated mesh is than placed to the ventral abdominal wall covering the closed hernia orifices (intended mesh-defect-ratio: 16). The mesh is fixed with two transfacial absorbable sutures and several absorbable tackers placed in double crown technique around the hernia orifice. The capnoperitoneum is released, the trocars removed and the fascia closed with an absorbable suture. The skin is sutured with absorbable sutures.
干预措施: Intraperitoneal onlay mesh (Procedure)
结局指标
主要结局
pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a
时间窗: 24 hours
pain, measured using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a 24 hours after the surgical procedure
primary outcome: pain numeric rating scale (NRS)
时间窗: 24 hours
pain, measured on the numeric rating scale (NRS) 0 - 10 24 hours after the surgical procedure.
次要结局
- pain mid-term(12 months)
- Functional recovery(5 years)
- LOS(30 days)
- Adverse events(30 days)
- recurrence and reoperation(5 years)
- Quality of life (SF 12)(5 years)