Registry Based, Randomized Controlled Trial Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain on postoperative day 1
研究概览
简要总结
Ventral hernias can be repaired using a variety of techniques, with smaller defects often being amenable to minimally invasive surgical (MIS) approaches. For many years, the standard of care MIS approach to ventral hernias has been the laparoscopic intraperitoneal onlay mesh (IPOM) approach, in which a large piece of mesh is placed inside of the abdomen and fixed to the inner abdominal wall using a combination of sutures and/or mechanical tacks. For selected patients, the IPOM approach has demonstrated benefits over open repair, including decreased postoperative length of stay and decreased incidence of surgical site infection.
However, concern regarding long-term outcomes of placing mesh inside the abdomen have spurred the search for alternate approaches to MIS ventral hernia repair. This includes the enhanced-view totally extraperitoneal (eTEP) approach, in which the retromuscular plane is accessed and developed so a large piece of mesh may be implanted outside of the abdominal cavity. The theoretical benefits of this approach are that patients may experience reduced pain because mechanical mesh fixation is not required (as compared to traditional IPOM approaches in which mesh is fixed to the inner abdominal wall) and that mesh is kept outside of the abdominal cavity and away from the viscera, allowing use of less expensive, uncoated mesh and theoretically reducing risk for long-term mesh related complications. While popularity of eTEP has grown, literature published regarding this approach has been mostly retrospective, consists of relatively small series of patients, and suffers from selection bias. For the one prospective study of eTEP published by Radu, et al, there was no comparator arm.
The investigators will conduct a registry-based randomized controlled trial comparing MIS approaches for repair of small to medium-sized ventral hernias, specifically eTEP versus IPOM. This will occur through the Americas Hernia Society Quality Collaborative (AHSQC).
Our hypotheses are multiple: 1) Patients with ventral hernias undergoing eTEP will experience a 30% decrease in pain scores by postoperative day 1 compared to patients undergoing IPOM; 2) eTEP will be associated with higher median direct costs per case versus IPOM; 3) eTEP will be associated with equivalent 1-year hernia recurrence rates versus IPOM; 4) eTEP will be associated with significantly increased intraoperative surgeon workload compared to IPOM.
详细描述
This will be a prospective, registry-based, single-blind, randomized controlled trial with a 1:1 allocation ratio. No important changes to the methods are anticipated. This will be a single-institution study performed at the Cleveland Clinic Foundation in Cleveland, and the AHSQC will serve as our platform for data collection. All enrollments and surgeries in this study will take place at Cleveland Clinic Main Campus.
The study will consist of 2 interventions: IPOM or eTEP. Two expert hernia surgeons with advanced MIS training will enroll patients and perform the operations.
A computer-generated randomization scheme will be built. Randomization will take place on the Research Electronic Data Capture (REDCap®) database program. Patients will be randomized to IPOM or eTEP in the operating room after induction of general anesthesia.
The primary outcome measure is early postoperative pain. Secondary outcome measures are cost, hernia recurrence, and surgeon workload as determined by the NASA Task Load Index (NASA-TLX). The investigators will also collect outcomes pertaining to abdominal wall-specific quality of life (measured by Hernia-Related Quality of Life inventory - HerQLes), and 30-day wound events. No changes to trial outcomes are anticipated, and no interim analyses will be performed. No stopping guidelines are needed, as both eTEP and IPOM represent current standards of care for ventral hernia repair.
Subjects will be blinded to the intervention. A similar number of incisions will be present on the abdomen in similar locations following each intervention, preventing patients from knowing which intervention they received. The investigators are unable to blind the operating surgeon to the intervention arm. The investigators are unable to blind the data collector, the research fellow, to the patients within each intervention arm. However, by utilizing data largely determined from the patients themselves, who will not be informed of the operation that they have received until after study completion, The investigators believe that they are presenting accurate data with limited bias. No subgroup analyses are planned. Patients will not be included for analysis at any time point for which their data is unavailable. Following their 1-year visit, patients will be informed regarding the intervention that they received.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patient
- •Primary ventral or incisional hernia defects
- •Midline defect with an expected hernia width equal to or less than 7 centimeters
- •Elective hernia repair
- •Considered eligible for hernia repair through a minimally-invasive approach
- •Able to tolerate general anesthesia
- •Able to give consent for participation
排除标准
- •Defects greater than 7 centimeters
- •Hernia defects considered to require an open approach
- •Prior mesh placement in the retrorectus space
- •Patients not able to understand and sign a written consent form
研究组 & 干预措施
Enhanced-view Totally Extraperitoneal (eTEP) Hernia Repair
Initial access into the retromuscular space is achieved using an optical trocar. Insufflation of CO2 is performed under direct visualization. Multiple assistant ports will be placed medial to the semilunar line to continue developing the retromuscular space. The medial insertion of the posterior rectus sheath will be incised to enter the preperitoneal plane and facilitate reduction of hernia contents. The contralateral posterior rectus sheath will be incised and the contralateral retrorectus space will be matured. Suture will be used to close any defect in the hernia sac. The defect will be measured, as will be the retrorectus space. The fascial defect will be closed with suture. Non-barrier coated mesh will be placed in the retrorectus space and flat positioning will be confirmed. Ports will be removed under direct visualization, and the abdomen desufflated. Anterior fascia of any larger ports (8mm or greater) will be closed.
干预措施: Ventral Hernia Repair (Procedure)
Intraperitoneal Onlay Mesh (IPOM) Hernia Repair
Access is achieved using an optical trocar. Insufflation of CO2 is performed. Two additional trocars are placed on the left side along the anterior axillary line. If necessary, auxiliary ports may be placed on the right side. When present, hernia contents are reduced using graspers. Adhesions between abdominal contents and the abdominal wall are lysed. The hernia defect is identified and measured internally with a sterile plastic ruler with the abdomen insufflated. Defect closure is performed using nonabsorbable suture. Mesh repair is performed using polypropylene mesh with an absorbable hydrogel barrier. Mesh is chosen to achieve a minimum 3 to 5-centimeter overlap from the edges of the closed defect. Inside the abdomen, the mesh is unrolled and positioning against the anterior abdominal wall is confirmed. Mesh edges are fixed circumferentially with permanent fixation. Ports are removed and the abdomen is desufflated. The anterior fascia of the 12mm port is closed.
干预措施: Ventral Hernia Repair (Procedure)
结局指标
主要结局
Pain on postoperative day 1
时间窗: postoperative day 1
Pain will be assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey and the Numeric Pain Rating Scale (NRS-11). The PROMIS pain intensity 3a survey is a National Institutes of Health developed and validated tool that focuses on patient-reported pain characteristics . The NRS-11 is a frequently utilized pain assessment that consists of an easily administered 0 to 10 Likert scale, in which higher scores reflect greater pain intensity.
次要结局
- Pain in post-anesthesia care unit (PACU), on postoperative day 7, at 30-day (15-45 day) follow-up, and at 1-year (9-15 month) follow-up.(immediately postoperatively in post-anesthesia care unit (PACU), on postoperative day 7, at 30-day (15-45 day) follow-up, and at 1-year (9-15 month))
- Postoperative narcotic requirements(at 30-day (15-45 day) follow-up)
- Hernia recurrence rates(1 year (9-15 month) follow-up)
- Intraoperative Surgeon Workload(index surgery)
- Abdominal wall-specific quality of life(Baseline, 30-day, 1-year postoperative)
- Wound events(at 30(± 15) days and 365 (± 90) days.)
- Direct costs(index surgical encounter)
研究者
Clayton Petro
Staff Surgeon
The Cleveland Clinic