Robotic Versus Laparoscopic Ventral Hernia Repair
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03490266|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2018
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Ventral||Procedure: Robotic Repair Procedure: Laparoscopic Repair||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Robotic Versus Laparoscopic Ventral Hernia Repair: A Multicenter Randomized Controlled Trial|
|Actual Study Start Date :||April 3, 2018|
|Actual Primary Completion Date :||April 9, 2020|
|Estimated Study Completion Date :||April 30, 2023|
Active Comparator: Laparoscopic Repair
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
The surgeon will be repairing the hernia laparoscopically.
Experimental: Robotic Repair
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
The surgeon will be utilizing a robotic system to repair the hernia.
- Total number of days in the hospital [ 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.
- Surgical Site Infection (SSI) [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]CDC definition
- Surgical Site Occurrence (SSO) [ 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.
- Hernia Reoccurence [ 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
- Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]Collected using HerQLes
- Patient centered outcomes [ Time Frame: post-operative at 1 month, 90 days, 1 year, 2 years, and 3 years ]Collected using EQ5D
- Cost from a healthcare perspective [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490266
|United States, Texas|
|UT Health-Memorial Hermann|
|Houston, Texas, United States, 77024|
|UTHealth-Lyndon B. Johnson (LBJ) Hospital|
|Houston, Texas, United States, 77026|
|Principal Investigator:||Shinil Shah, DO||UTHealth-Memorial Hermann|
|Principal Investigator:||Mike K Liang, MD||UTHealth-Lyndon B. Johnson (LBJ) Hospital|