Clinical trial: Randomized study of lap vs. robotic hernia surgery underway

A multicenter, randomized study comparing laparoscopic and robotic assisted surgical approaches is being conducted to examine outcomes for ventral hernia repairs.

In the trial precis, the researchers wrote, “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.”

Study participants will be randomized to two arms, one for laparoscopic hernia repair and the other for robotic repair. Patients in both arms will be treated with a mid-density polypropylene mesh with a one-sided adhesion barrier.

The primary outcomes studied are length of stay in the hospital and readmissions out to 90 days. Secondary outcomes include the occurrence of surgical-site infection, hematoma, seroma, dehiscence, necrosis, nonhealing wound, hernia recurrence, and several cost and quality-of-life measures.

Patients included must be over age 18 and undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair. Exclusions include those unlikely to survive beyond 2 years based on surgeon judgment or are unlikely to follow up. In addition, patients are excluded if they have advanced COPD or heart failure, a history of open abdomen or extensive lysis of adhesions for bowel obstruction, ascites caused by cirrhosis or malignancy, active infection, or a large hernia larger than 12 cm. Estimated enrollment is 120 patients, and the researchers expect the study to end in 2023.

For more details on the study (NT03490266), go to clinicaltrials.gov.

A multicenter, randomized study comparing laparoscopic and robotic assisted surgical approaches is being conducted to examine outcomes for ventral hernia repairs.

In the trial precis, the researchers wrote, “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.”

Study participants will be randomized to two arms, one for laparoscopic hernia repair and the other for robotic repair. Patients in both arms will be treated with a mid-density polypropylene mesh with a one-sided adhesion barrier.

The primary outcomes studied are length of stay in the hospital and readmissions out to 90 days. Secondary outcomes include the occurrence of surgical-site infection, hematoma, seroma, dehiscence, necrosis, nonhealing wound, hernia recurrence, and several cost and quality-of-life measures.

Patients included must be over age 18 and undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair. Exclusions include those unlikely to survive beyond 2 years based on surgeon judgment or are unlikely to follow up. In addition, patients are excluded if they have advanced COPD or heart failure, a history of open abdomen or extensive lysis of adhesions for bowel obstruction, ascites caused by cirrhosis or malignancy, active infection, or a large hernia larger than 12 cm. Estimated enrollment is 120 patients, and the researchers expect the study to end in 2023.

For more details on the study (NT03490266), go to clinicaltrials.gov.

A multicenter, randomized study comparing laparoscopic and robotic assisted surgical approaches is being conducted to examine outcomes for ventral hernia repairs.

In the trial precis, the researchers wrote, “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.”

Study participants will be randomized to two arms, one for laparoscopic hernia repair and the other for robotic repair. Patients in both arms will be treated with a mid-density polypropylene mesh with a one-sided adhesion barrier.

The primary outcomes studied are length of stay in the hospital and readmissions out to 90 days. Secondary outcomes include the occurrence of surgical-site infection, hematoma, seroma, dehiscence, necrosis, nonhealing wound, hernia recurrence, and several cost and quality-of-life measures.

Patients included must be over age 18 and undergoing elective ventral hernia repair deemed appropriate for minimally invasive repair. Exclusions include those unlikely to survive beyond 2 years based on surgeon judgment or are unlikely to follow up. In addition, patients are excluded if they have advanced COPD or heart failure, a history of open abdomen or extensive lysis of adhesions for bowel obstruction, ascites caused by cirrhosis or malignancy, active infection, or a large hernia larger than 12 cm. Estimated enrollment is 120 patients, and the researchers expect the study to end in 2023.

For more details on the study (NT03490266), go to clinicaltrials.gov.