A prospective randomized clinical trial “PROVE-IT” was conducted at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio to compare the patient-reported outcomes of robotic surgery against the conventional laparoscopic surgery following intraperitoneal mesh repair of ventral hernia. The trial was conducted between September 2017 and January 2020; the minimum follow-up duration was 30 days.

Seventy-five patients aged ≥18 years with primary or incisional midline ventral hernias of ≤7 cm, which could be repaired with the minimally invasive surgery were included in the study. Recruitment was done by two surgeons, who were trained in advanced laparoscopy and complex abdominal wall reconstruction and also robotic surgery. They were randomized to either robotic surgery or laparoscopic approach. Pain on the first postoperative day was the primary outcome, which was measured by the 0 to 10 Numerical Rating Scale (NRS-11) preoperatively and postoperatively on days 1, 7, 30 and at one year. The secondary outcomes were pain as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (short form 3a) and assessment of abdominal-wall-specific quality of life (QOL) using the hernia-related QOL survey tool (HerQLes), duration of surgery and hospitalization, recurrence of ventral hernia and cost were the secondary outcomes. These were recorded at one month and one year.

Of the 75 patients, 39 underwent robotic surgery and 36 underwent laparoscopic repair of the ventral hernia. The robotic repair was considerably longer versus laparoscopic approach; 146 vs 94 minutes, respectively (p < .001). The two groups were comparable in terms of the NRS-11 scores (5 vs 5; p = 0.61), PROMIS 3a and HerQLes, duration of hospitalization (10 vs 25 hours; p = 0.17) and overall complication rates (8% vs 6%; p > 0.99) for laparoscopic and robotic groups, respectively. 

However, a marked difference between the two approaches was observed in the cost of repair. The total cost was much more with robotic surgery vis à vis laparoscopic surgery, 1.13 vs 0.97, respectively (p = 0.03). The extra 52 minutes of the operative room time with robotic repair added to the total costs, while the costs of the disposables/reusables were same in the two groups.

The increased operative time and cost with robotic repair emerged as the most significant findings of this trial. The study suggests that the difference in the operative time between the two techniques could be overcome by enhancing operator efficiency. This would reduce the costs of robotic surgery.

However, based on the present findings, the study concluded that while there were no significant differences in postoperative pain, complication rates, hospital length of stay and QOL, the increased surgery time and the added cost thereof do not offer any added advantage and do not justify use of the robotic approach for ventral hernia repair.