Hernia, Ventral
Conditions
Keywords
Ventral Hernia, Hernia Repair
Brief summary
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
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.
Interventions
PROCEDURERobotic Repair
The surgeon will be utilizing a robotic system to repair the hernia.
PROCEDURELaparoscopic Repair
The surgeon will be repairing the hernia laparoscopically.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of days in the hospital | 90 days post-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (SSI) | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | CDC definition |
| Surgical Site Occurrence (SSO) | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam. |
| Hernia Reoccurence | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | A hernia that was repaired in the past but has returned |
| Patient centered outcomes | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | Collected using HerQLes |
| Cost from a healthcare perspective | post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years | Looking at differences in what is spent for robotic repair and laparoscopic repair of ventral hernias |
Countries
United States
Outcome results
None listed