Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence
研究概览
简要总结
The purpose of this study is to determine how the robotic retromuscular hernia repair compares to the open retromuscular hernia repair for large hernia defects in patients at higher risk of wound complications.
详细描述
All patients presenting to the Greenville Health System Hernia Center who meet the inclusion criteria will be considered for enrollment. Patients who qualify and agree to participate will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular ventral hernia repair. Data to be collected includes the following: demographic information, medical characteristics, medications, medical and surgical history, operative details, hospital stay data, and patient-reported outcomes via a quality of life questionnaire. Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.
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
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
- •Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm.
- •At least one of the following risk factors: Body Mass Index > 30, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month)
排除标准
- •Current abdominal wall infection
- •Presence of ileostomy, colostomy, or ileal conduit
- •Center for Disease Control wound class 3 or 4
- •Hernia defect < 7 cm or >15 cm
- •Pregnant women
结局指标
主要结局
Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence
时间窗: Through study completion, an average of 2 years
A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.
次要结局
- All Surgical Site Occurrences(Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years)
- Surgical Site Occurrences Requiring Procedural Intervention(Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years)
- All Surgical Site Infections(Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years)
- Surgical Site Infections Requiring Procedural Intervention(Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years)
- Length of Stay at Hospital Measured in Days(Time from procedure until discharge, an expected range of 2 to10 days)
- Operative Time (Procedure Start to Procedure Finish Measured in Minutes)(Day of surgery)
- Cost for Hospital Charges From Billing Office(Through study completion, an average of 2 years)
- BMI(Measured at study enrollment)
- Hernia Width(measured at surgery)
- Hernia Length(measured at surgery)
- Quality of Life Via Questionnaire - 30 Days(assessed at Baseline and Post-operatively at 30 days)
- Quality of Life Via Questionnaire - 6 Through 12 Months(assessed at Baseline and Post-operatively at 6 through 12 months. Data for the 6 and 12-month patient reported outcomes were combined for analysis.)
- Quality of Life Via Questionnaire - 24 Months(assessed at Baseline and Post-operatively at 24 months)
- Pain Score - 30 Day Patient Reported Outcomes(assessed at Baseline and Post-operatively at 30 days.)
- Ventral Hernia Recurrence Inventory 1 Year(assessed at Baseline and Post-operatively at 12 months.)
- Ventral Hernia Recurrence Inventory 2 Years(assessed at Baseline and Post-operatively at 24 months)
- Hernia Recurrence(assessed Post-operatively as 24 months)
- Conversion to Open(Assessed at index surgery.)
- Pain Score - 6 or 12 Month Patient Reported Outcomes(assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis.)
- Pain Score - 24 Month Patient Reported Outcomes(assessed at Baseline and Post-operatively at 24 months)