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The findings of a new study raises questions about the benefits of robotic hernia repair surgery, indicating certain procedures may provide no benefit over more traditional laparoscopic surgery.
In a report published last week in the medical journal JAMA Surgery, researchers with The Cleveland Clinic indicate that even though robotic surgery is more expensive, the procedure does not appear to provide any advantages in operative time, outcomes, quality of life, surgical complications or length of hospital stay when compared to laparoscopic surgery for repairing ventral hernias.
Researchers conducted a single-blinded, randomized clinical trial involving 75 patients; 36 of whom underwent laparoscopic surgery for ventral hernia repair, and 39 of whom underwent robotic surgery. There was a minimum 30-day follow-up, and all were completed between September 2017 and January 2020.
The study looked for differences in the Numeric Rating Scale (NRS-11) on the first postoperative day. In addition, researchers looked for patient-reported outcomes such as quality of life, operative time, wound morbidity, hernia recurrence, length of hospital stay and cost.
According to the findings, there were no significant differences in the NRS-11 scores, hernia-specific quality-of-life-scores, length of stay or complication rates. However, the robotic surgery added 13% to the cost, mainly due to additional operating room time, as the surgeries were much longer. Robotic hernia repair surgeries had a mean operative time of 146 minutes, compared to only 94 minutes with laparoscopic surgery.
“Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes,” the researchers concluded. “The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.”
The findings come as medical device manufacturers such as C.R. Bard, Ethicon and Atrium face almost 15,000 hernia mesh lawsuits in federal courts nationwide, each involving similar allegations that design defects associated with widely-used surgical mesh devices are prone to failure, causing painful and debilitating complications.
Recently released court records indicate there are now at least 9,400 Bard hernia mesh claims, 3,100 Ethicon Physiomesh claims and 2,400 Atrium C-Qur mesh claims pending in the federal court system, which are consolidated as part of three separate MDLs (multidistrict litigations) involving claims against each of the manufacturers.
If each of the manufacturers are unable to dismiss the cases or negotiate hernia patch settlements to resolve cases, thousands of individual claims may ultimately be remanded back to U.S. District Courts nationwide for separate trial dates in coming years.