Bariatric Surgery: Staple Line Reinforcement Ups Leak Risk

Veronica Hackethal, MD

September 26, 2016

Staple line reinforcement during laparoscopic sleeve gastrectomy is associated with increased leakage from the stomach compared with not using this technique, according to a study published in the September issue of the Annals of Surgery.

Staple line reinforcement refers to material placed between staples used to divide the stomach during laparoscopic sleeve gastrectomy.

"These findings are very important, as currently 80% of surgeons are using staple line reinforcement. Not only might their use be associated with increased leaks, but they are also quite expensive," lead author Matthew Hutter, MD, MPH, from Massachusetts General Hospital, Boston, told Medscape Medical News.

"If surgeons stop using these staple line reinforcements, they will need to pay even closer attention to prevent bleeding events, which tended to be a bit higher if staple line reinforcements are not used," he added.

Bariatric surgery is very effective for treating obesity, which now affects more than 20 million Americans, he explained. Laparoscopic sleeve gastrectomy has rapidly become the most common bariatric procedure in the United States, accounting for about 42% of these types of surgeries.

The study showed that this procedure is "remarkably safe," with complication rates less than 1%, according to Dr Hutter. However, to understand how laparoscopic sleeve gastrectomy could be even safer and more effective, Dr Hutter and colleagues looked at the effect of staple line reinforcement, oversewing of the staple line (suturing over the staple line to decrease leaks and bleeds), bougie size (a bougie is a tube that helps the surgeon measure where to place the staples that divide the stomach), and distance from the pylorus on 30-day outcomes, as well as weight loss and obesity-related comorbidities such as diabetes at 1 year.

Researchers used data from 189,477 laparoscopic sleeve gastrectomy surgeries performed by 1634 surgeons at 720 centers between 2012 and 2014. Data came from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program data registry, which covers more than 90% of bariatric surgeries performed annually in the United States.

The high number of cases represents the largest group of laparoscopic sleeve gastrectomy patients ever evaluated, and revealed findings that are not always apparent even in high-volume centers, according to Dr Hutter. The study is also the first to do a surgeon-level analysis to control for variations in surgical technique that may occur based on anatomic and technical issues revealed during the operation.

Results showed that 80.3% of surgeons used some kind of staple line reinforcement. At the patient level, performing staple line reinforcement was associated with higher leak rates (0.96% vs 0.65%; odds ratio [OR], 1.20; 95% confidence interval [CI], 1.00 - 1.43) and lower bleed rates (0.75% vs 1.00%; OR, 0.74; 95% CI, 0.63 - 0.86) compared with not performing staple line reinforcement. When analyzed at the surgeon level, leak rates remained significant, whereas bleeding rates became nonsignificant.

In both patient- and surgeon-level analyses, higher bougie size (≥38 Fr) was linked to significantly lower leaks than lower bougie size (<38 Fr; patient level: 0.80% vs 0.96% [OR, 0.72; 95% CI, 0.62 - 0.94]; surgeon level: 0.84% vs 0.95% [OR, 0.90; 95% CI, 0.80 - 0.99]).

In addition, higher bougie size (≥40 Fr) was significantly linked to more weight loss at 1 year compared with lower bougie size (<40 Fr; P < .001).

Distance from the pylorus did not significantly affect leaks or bleeds. Increasing distance from the pylorus was associated with significantly increased weight loss at 1 year. A distance of 6 cm or more showed the highest reduction in body mass index (3.7%) vs less than 4 cm (1.2%; P < .001).

Staple line oversewing was associated with a 1.3% decrease in excess body mass index at 1 year compared with doing nothing (P = .02).

None of the different techniques had an effect on obesity-related comorbidities.

Although the study could not address why staple line reinforcement may be associated with increased leaks, increased ischemia caused by two layers of material in the staple line may be involved, the authors suggest. Other explanations include decreased staple heights and increased staple bulk where two staple layers become sandwiched together.

"Additional studies will need to look specifically at which specific materials used in staple line reinforcement are associated with increased leaks, and look at other techniques that we use in the operating room that we can do, or not do, to make the operations even more safe and effective," Dr Hutter concluded.

The authors have disclosed no relevant financial relationships.

Ann Surg. 2016;264:464-473. Abstract

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