Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: a Multicenter International Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 主要终点
- Length of postoperative hospital stay
研究概览
简要总结
In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.
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
- None
盲法说明
This is an open-label Randomized Controlled Trial (RCT) where the patient, surgeon, research coordinators and hospital staff will be aware of the treatment arm after randomization. As the open approach is performed using a large midline incision, whereas the robotic approach applies only 6 or 7 small incisions (or less if no posterior component separation is needed), blinding of patients and physicians is difficult.
Evaluation of the radiographic imaging of the abdominal wall at 24 months (MRI or CT scan) will be done by radiologists at the local participating center blinded to the randomized treatment arm. This will be a blinded evaluation for the presence or absence of hernia recurrence. Data analysis will be performed in a blinded manner by an independent statistician.
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
- •- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)
排除标准
- •Pregnant or suspected pregnancy
- •Not-curatively treated malignancy, with life expectancy less than 24 months
- •Patients unable to give informed consent or complete study specific questionnaires
- •Emergency surgery
- •Primary ventral hernia repair
- •Exclusively lateral hernias not involving the midline
- •Incisional hernia repair after open abdomen or enterocutaneous fistula
- •Active wound infection
- •Previous anterior or posterior component separation
- •Patients with an existing ostomy
- •Patients with a life expectancy of less than 24 months
- •Patients suspected of being unable to comply with the study protocol
研究组 & 干预措施
rTAR
Patients randomized in the robotic group will undergo the technique for intra-and perioperative management for robotic complex abdominal wall repair cases as used in the center. A robotic surgical platform (da Vinci X or da Vinci Xi Surgical System, Intuitive Surgical, Aubonne, Switzerland) will be used and a retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference.
干预措施: incisional hernia repair (Procedure)
oTAR
Patients randomized in the open group will undergo the technique for intra-and perioperative management for open complex abdominal wall repair cases as used in the center. A retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference.
干预措施: incisional hernia repair (Procedure)
结局指标
主要结局
Length of postoperative hospital stay
时间窗: hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days
Length of postoperative hospital stay
次要结局
- Conversion rate(Per-operative)
- Readmission rate(30 Days and 3 months postoperative)
- Post-anesthetic discharge scoring system(From the end of surgery (last skin suture) until discharge, assessed up to 20 days)
- Surgical site related complications(30 days)
- Postoperative visual analogue scale pain score(From the end of surgery (last skin suture) until discharge, assessed up to 20 days)
- EuraHS Quality of Life Scoring(Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months)
- Body Image Scale(Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months)
- Skin-to-skin operative time(Per-operative (minutes))
- Postoperative complications(30 days)
- Hernia recurrence(30 days, 3 Months, 12 months, 24 months, 60 months)
- Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence(30 days, 3 Months, 12 months, 24 months, 60 months)
- Reoperation rate(30 days)
研究者
Filip Muysoms
Head of General Surgery
Algemeen Ziekenhuis Maria Middelares