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Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh

医学 外科 随机对照试验 疝修补术 腹腔镜检查 可视模拟标度 临床试验 生活质量(医疗保健) 普通外科 内科学 护理部
作者
Clayton C. Petro,Sam Zolin,David M. Krpata,Hemasat Alkhatib,Chao Tu,Michael J. Rosen,Ajita S. Prabhu
出处
期刊:JAMA Surgery [American Medical Association]
被引量:23
标识
DOI:10.1001/jamasurg.2020.4569
摘要

Despite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.To determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.A registry-based, single-blinded, prospective randomized clinical trial at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, completed between September 2017 and January 2020, with a minimum follow-up duration of 30 days. Two surgeons at 1 academic tertiary care hospital. Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair.Patients were randomized to a standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh.The trial was powered to detect a 30% difference in the Numerical Rating Scale (NRS-11) on the first postoperative day. Secondary end points included the Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost.Seventy-five patients completed their minimally invasive hernia repair: 36 laparoscopic and 39 robotic. Baseline demographics and hernia characteristics were comparable. Robotic operations had a longer median operative time (146 vs 94 minutes; P < .001). There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations. There were no significant differences in NRS-11 scores preoperatively or on postoperative days 0, 1, 7, or 30. Specifically, median NRS-11 scores on the first postoperative day were the same (5 vs 5; P = .61). Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores, as well as length of stay and complication rates, were similar. The robotic platform adds cost (total cost ratio, 1.13 vs 0.97; P = .03), driven by the cost of additional operating room time (1.25 vs 0.85; P < .001).Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.ClinicalTrials.gov Identifier: NCT03283982.
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