Robotic Versus Laparoscopic Ventral Hernia Repair

Study Overview
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Brief Summary
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Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Minimally invasive ventral hernia repair decreases rates of surgical site infection and hospital length of stay, without affecting recurrence, however the laparoscopic approach to ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in the US. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.

Detailed Description
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Ventral hernias are a common disease and one-half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias are associated with substantial morbidity including surgical site infection, hernia recurrence, and reoperation. Randomized controlled trials and nationwide databases have shown that minimally invasive ventral hernia repair (i.e. laparoscopic ventral hernia repair) as opposed to open ventral hernia repair is associated with decreased rates of surgical site infection and hospital length of stay with no impact on long-term outcomes of hernia recurrence. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair. The growth of the robotic platform in surgery is growing exponentially. Despite this, the evidence supporting robotics remains limited. Studies demonstrating benefit such as improved outcomes or decreased hospital length of stay, are largely cohort studies subject to substantial bias. Among randomized controlled trials, none have demonstrated benefit with robotic surgery. Recently, the America's Hernia Society (AHS) has endorsed robotic ventral hernia surgery. A series of studies published under the AHS Quality Collaborative (AHSQC) database have demonstrated improved outcomes with robotic ventral hernia repair when compared to open and laparoscopic surgery. However, the results of these studies remain hypothesis generating and randomized controlled trials are needed. This study would represent among the first randomized controlled trials assessing the effect of robotic versus laparoscopic ventral hernia repair.

Official Title
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Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial

Conditions
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Hernia, Ventral

Intervention / Treatment
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* Procedure: Robotic Repair
* Procedure: Laparoscopic Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -All patients undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair. Exclusion Criteria: Patients unlikely to survive beyond 2 years based upon surgeon judgment (e.g. advanced cirrhosis or metastatic cancer) Patients unlikely to follow-up (e.g. lives out of state or no phone) Advanced COPD or CHF History of open abdomen or extensive lysis of adhesions for bowel obstruction Ascites due to cirrhosis or malignancy Active infection such as infected mesh Ventral hernia size greater than 12 cm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Repair<br>The abdomen will be entered and insufflated utilizing a 5 mm optical port. Only 5 mm ports will be utilized laterally to take down all anterior abdominal wall adhesions. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through a 11 or 12 mm port placed through the defect. Excision of hernia sac and preperitoneal fat and defect closure will be performed per current practice. The mesh will be secured in four points with 0-PDS sutures and/or tacked with a double crown of tacks per our current practice. | Procedure: Laparoscopic Repair<br>* The surgeon will be repairing the hernia laparoscopically.<br>|
| Experimental: Robotic Repair<br>Three lateral ports will be placed including a 12 port for the camera. Adhesions will be taken down from the anterior abdominal wall. Hernia sac and preperitoneal fat will be excised per current practice and defect will be closed using a running locking barbed suture. A mid-density polypropylene mesh with a one-sided adhesion barrier that provides at least 5 cm of overlap in all directions will be inserted through the 12 mm port. The mesh will be secured circumferentially with a running barbed suture. | Procedure: Robotic Repair<br>* The surgeon will be utilizing a robotic system to repair the hernia.<br>* Other names: Endoscopic Instrument Control System, Model IS3000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of days in the hospital | Total number of days spent in the hospital. This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery. | 90 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection (SSI) | CDC definition | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | 
| Surgical Site Occurrence (SSO) | Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam. | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | 
| Hernia Reoccurence | A hernia that was repaired in the past but has returned | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | 
| Patient centered outcomes | Collected using HerQLes | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | 
| Patient centered outcomes | Collected using EQ5D | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | 
| Cost from a healthcare perspective | Looking at differences in what is spent for robotic repair and laparoscopic repair of ventral hernias | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventral Hernia, Hernia Repair