By Christina Frangou
Chicago—In a study that looked at “real-world” outcomes after inguinal hernia repair in the United States, laparoscopic surgery and open surgery with local anesthesia were protective against both minor and major complications.
“Compared to an open approach with general anesthesia, inguinal hernia repair done with a laparoscopic approach or an open approach with local anesthesia have superior safety, even after controlling for patient characteristics,” said lead author Aaron S. Rickles, MD, general surgery resident and research fellow at the University of Rochester Surgical Health Outcomes & Research Enterprise (SHORE).
Dr. Rickles presented the findings at the 2012 Clinical Congress of the American College of Surgeons (ACS).
The study relies on administrative data, which limits the strength of the findings. Even so, it is the first large “real-world” report to demonstrate that laparoscopic inguinal hernia repair is superior to open repair with general anesthesia. The latter is the most commonly performed type of repair in this country.
Earlier randomized controlled trials have shown that the laparoscopic approach is associated with an increased risk for intra-abdominal injury, although it has the benefit of reduced postoperative pain and shorter recovery time (Cochrane Database Syst Rev 2003;1:CD001785; N Engl J Med 2004;350:1819-1827). But those early studies were conducted when laparoscopic surgery was still new and surgeons were less experienced with minimally invasive surgery.
The researchers studied data collected by the National Surgical Quality Improvement Program (NSQIP) between 2005 and 2010. During that period, 71,126 inguinal hernia repairs were performed. Most of them, 58.3%, were done as open repairs with general anesthesia. Laparoscopic repairs and open repairs under local anesthesia accounted for 21.8% and 19.95%, respectively.
Multivariate analysis showed that laparoscopic surgery was associated with significantly reduced rates of minor and major complications compared with open repairs. Laparoscopic repairs reduced the risk for major complications by about 20%, with an odds ratio (OR) of 0.801 (95% confidence interval [CI], 0.659-0.974).
Despite this finding, investigators did not detect any difference in the safety profile between laparoscopic repair and open repair with local anesthesia. “We found no statistically significant difference in risk of minor or major complications between a laparoscopic approach and an open approach with local anesthesia,” said Dr. Rickles.
Surgeons, including those affiliated with the study, noted that the study has considerable weaknesses. It is an observational study, not a randomized trial, so cause and effect cannot be definitively established. Investigators used administrative data that may contain inaccuracies or inconsistencies, and the hospital mix in ; NSQIP, although varied, may overrepresent academic hospitals at 58%.
Guy R. Voeller, MD, professor of surgery, University of Tennessee Health Sciences Center, in Memphis, said that the study has problems common in the inguinal hernia literature.
“We don’t know the experience of surgeons in the laparoscopic repair, we don’t know how many they do a year [or] the types of open repair. There are so many variables in here that I think you will find many open hernia surgeons who would disagree vehemently with the conclusions.”
“It’s interesting to see that laparoscopic inguinal hernia [repair] was superior to open repair with general anesthesia,” said Dr. Voeller. “But based on this, I would conclude that an open repair with local anesthesia is the best repair because it reduces the risk of both minor and major complications and [is] without the risks of general anesthesia.”
It is important to put the study findings in perspective. The operative approach, although important, was not as predictive as patient demographics with regard to complications. Factors such as age older than 65 years (OR, 1.418; 95% CI, 1.206-1.666), having an American Society of Anesthesiologists (ASA) class greater than 2 (OR, 1.895; 95% CI, 1.579-2.273), renal insufficiency (OR, 2.422; 95% CI, 1.633-3.593), dependent functional status (OR, 3.071; 95% CI, 2.330-4.041) and hepatic insufficiency (OR, 3.577; 95% CI, 2.329-5.494) all presented greater risk for complications. Consistent with other studies, patients undergoing emergent surgery faced a significantly increased risk for complications, with an odds ratio of 3.393 (95% CI, 2.684-4.289) (Table).
Still, the operative approach is important because it is a variable that surgeons can control, said Dr. Rickles.
“Patient characteristics like ASA score, hepatic insufficiency, renal insufficiency, we can’t really change. But this is something we as surgeons can do differently to improve the outcomes of patients.”