robotic repair
ProcedureThe surgeon will be utilizing a robotic system to repair the hernia.
Other names: da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000
NCT Number: NCT03490266
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
UT Health-Memorial Hermann, Houston, Texas, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-All patients undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair.
Exclusion criteria
The surgeon will be utilizing a robotic system to repair the hernia.
Other names: da Vinci Si Surgical System, Endoscopic Instrument Control System, Model IS3000
The surgeon will be repairing the hernia laparoscopically.
Time frame: 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.
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
CDC definition
Time frame: 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.
Time frame: 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
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Collected using HerQLes
Time frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years
Collected using EQ5D
Time frame: 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
The University of Texas Health Science Center, Houston
Other
Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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