|Year : 2022 | Volume
| Issue : 2 | Page : 61-67
Staple-line reinforcement in laparoscopic sleeve gastrectomy: Needful or excessive care?
Eduardo Lemos de Souza Bastos1, Almino Cardoso Ramos2
1 Department of Gastrointestinal Surgery, Marilia School of Medicine, Marilia, Brazil
2 Gastro-Obeso-Center - Advanced Institute for Metabolic Optimization, São Paulo, Brazil
|Date of Submission||16-May-2022|
|Date of Acceptance||17-Jul-2022|
|Date of Web Publication||12-Aug-2022|
Eduardo Lemos de Souza Bastos
Department of Gastrointestinal Surgery, Marilia School of Medicine, Marilia
Source of Support: None, Conflict of Interest: None
Laparoscopic sleeve gastrectomy (LSG) has achieved high approval rates as stand-alone weight loss procedure in recent years. Its safety and effectiveness have been clearly established by numerous published studies. On the other hand, there has been great concern about complications related to the long staple line, mainly bleeding and leaks. Although this concern is universal among bariatric surgeons, strategies to prevent complications related to the staple line are not consensual. Accordingly, staple-line reinforcement methods have been widely proposed in an attempt to reduce the risk of these adverse events. However, nonreinforced but technically well-performed staple line can also be a very safe option, saving operative time and procedure-related costs. Therefore, the purpose of this narrative review is to discuss current options for minimizing the risk of staple line-related bleeding and leaks in LSG, focusing on technical issues and reinforcement methods.
Keywords: Bariatric Surgery, Surgical Staplers, Anastomotic Leak, Hemorrhage, Postoperative Complications
|How to cite this article:|
Bastos EL, Ramos AC. Staple-line reinforcement in laparoscopic sleeve gastrectomy: Needful or excessive care?. J Bariatr Surg 2022;1:61-7
|How to cite this URL:|
Bastos EL, Ramos AC. Staple-line reinforcement in laparoscopic sleeve gastrectomy: Needful or excessive care?. J Bariatr Surg [serial online] 2022 [cited 2022 Dec 4];1:61-7. Available from: http://www.jbsonline.org/text.asp?2022/1/2/61/353717
| Introduction|| |
Laparoscopic sleeve gastrectomy (LSG) indications has growing worldwide and now accounts for about 60% of all interventional bariatric and metabolic procedures.,,, Long-lasting weight loss, control of obesity-related comorbidities and virtual absence of significant gastrointestinal and nutritional adverse events can explain such expressive percentages.,
In addition, apparent technical simplicity may have contributed to the exponential growth of LSG as only one organ in a single surgical field is addressed and advanced endosuture skills are generally not required. However, this simplicity can be misleading as a safe procedure is based on meticulous technical standardization combined with essential tips and tricks.
Basic surgical steps of LSG have already been fairly well standardized over the years, but the routine use of staple-line reinforcement (SLR) remains nonconsensual. Although several studies have showed little or no advantage,,,,,,,,,, SLR has commonly been used in daily practice. According to the last four editions of the International LSG Summits, approximately 70% of surgeons routinely adopt some type of SLR.,,, Such rates are also endorsed by scientific publications based on the extensive database of the Bariatric and Metabolic Surgery Accreditation and Quality Improvement Program (MBSAQIP).,,,,,, Likewise, retrieved medical records from German Bariatric Surgery Registry showed that 67.4% of patients underwent SG as primary procedure from 2005 to 2013 had the staple-line reinforced, either by buttress materials or oversewing. Corroborating this preferences, a recent review of 11 randomized controlled trials covering almost 2,500 patients undergoing LSG was favorable to SLR in reducing the incidence of postoperative bleeding and leaks.
However, recently published data from MBSAQIP including 434,030 patients undergoing primary LSG between 2015 and 2018 showed a trend toward a reduction in routine SLR use (66.8% in 2015 vs. 63.2% in 2018; P < 0.001). Concurrently, significant reduction in operative time, length of stay, readmission, and major complication rates was also observed, suggesting an improvement in the surgeon's technical proficiency over time. In addition, a web-based survey that gathered cumulative data from more than five hundred thousand procedures worldwide showed that SLR appears to be included into technical routine of just over half of surgeons who perform sleeve surgery. Furthermore, a recent Turkish National Survey showed that the majority of respondents (56%) did not use any reinforcement method. These lower percentages may be indeed a more accurate portrayal of daily practice outside of high-volume referral centers. [Table 1] summarizes these data.
|Table 1: Percentage of routine use of staple-line reinforcement in laparoscopic sleeve gastrectomy according to several database|
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Surgeon's practice aside, scientific analyzes of published studies have showed high heterogeneity, profound technical discrepancies and conflicting results, preventing a definitive position statement on the routine use of SLR in LSG so far. Thus, the purpose of this narrative review is to discuss the technical options to minimize the risk of bleeding and leaks in the LSG staple-line, focusing on SLR methods and technical issues.
| Staple-Line Reinforcement: An Overview|| |
SLR is any additional method applied to the staple-line during or after the stapling process targeted to treat or prevent adverse events. Bariatric surgeons have two main options in daily practice: oversewing and buttress materials.
Oversewing has been commonly used as an affordable method, either through a continuous transmural (covering all layers of the gastric wall) or extramucosal imbrication suture (Lembert's technique).,,,,, Although both absorbable and nonabsorbable surgical thread can be used, the former usually causes a less pronounced inflammatory reaction, which can minimize the risk of complications such as stenosis and/or ulceration. However, oversewing can be related to some concerns: (1) increased operative time; (2) continuous suture can be “ischemic” and may predispose to leaks; (3) the suture itself can be a source of bleeding and hematomas; (4) and small holes in the gastric wall caused by needle puncture and surgical thread and/or tissue tearing due to knot tightening can become sites prone to leaks, mainly in cases evolving with intra-sleeve high pressure such as postoperative vomiting.,,,,,,, Omentopexy can be an additional reinforcement, but this maneuver seems to be more commonly used to prevent twisting of the stomach.
On the other hand, buttress materials are loaded with the cartridge and incorporated to the staple-line at each firing, making it stronger and enhancing the healing process. The most common buttressing materials available are synthetic polymers and biological tissue.
Gore® Seamguard® (W. L. Gore and Associates, Inc., Flagstaff, AZ, USA) is a synthetic absorbable copolymer membrane constructed from polyglycolic acid/trimethylene carbonate. According to manufacturer's portfolio, Seamguard® can add strength and promote cell infiltration and ingrowth in the staple-line, reducing the risk for bleeding and leaks, while it is gradually absorbed for approximately 6 months. The bioabsorbable membrane is the most common buttressing used in daily practice and some studies corroborated the aforementioned risk reduction.,,,,
Duet TRS™ tissue reinforcement system (Medtronic®, Mansfield, MA, USA) is a device with cartridge containing strips made of absorbable synthetic polymers that was sparsely reported in the literature., It was discontinued by the company in 2012 and now has been replaced by Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Medtronic®, Mansfield, MA, USA).
Peri-Strips Dry® with Veritas® (PSD-V; Synovis Baxter Healthcare Corporation™, Baxter International Inc., USA) is a biologic tissue (collagen matrix) composed of noncross-linked bovine pericardium treated with sodium hydroxide. According to the manufacturer's portfolio, PSD-V® is completely remodeled and becomes histologically indistinguishable from the host tissue approximately 6 weeks postimplant. Although still controversial, biological strips have been used as an SLR in LSG.,,
Finally, Floseal® Hemostatic Matrix, Tissell® Fibrin Sealant, TachoSil®, Easyspray™ (all by Baxter Healthcare Corporation™, Baxter International Inc., USA), BioGlue® Surgical Adhesive (CryoLife, Inc., Kennesaw, USA), Ifabond® (Péters-Surgical, Bobigny, Fr), Evicel™ (Ethicon, J and J Company, USA) and Glubran 2® (GEM s.r.l. Viareggio, Italy) are some examples of sealants that have been sparingly adopted to minimize the risk of staple line-related complications in bariatric surgery.,,,,,
Despite the possible applicability in bariatric surgery, sealants are costly products mainly indicated to stop active bleeding. Even so, a recent systematic review evaluated the effectiveness of fibrin sealant in reducing staple-line-related complications after bariatric surgery. The meta-analysis was performed based on data from 9 randomized clinical trial published over a 10-year timespan (2008–2018) and included 2,136 patients, most undergoing LSG. Compared with no reinforcement, the fibrin sealant showed slightly lower bleeding rate, longer total operative time and no significant difference regarding leaks, reoperation, hospital stay and gastric stricture rates.
| Staple-Line Reinforcement: Selective or Routine Use?|| |
The debate regarding SLR in LSG is not between “always” or “never,” but between “always” (routine use) or “sometimes” (selective use). Currently, some surgeons argue that SLR should be incorporated as a mandatory surgical step in LSG, while others reserve the SLR only for situations with a higher risk of complications.
The argument in favor of routine SLR use is supported by the lack of a reliable predictor of staple line-related complications, leading many surgeons to choose to reinforce all procedures, including those considered at low risk. Notwithstanding, the routine use of SLR implies the assumption that the technology embedded in modern staplers, applied under favorable technical conditions by well-trained surgeons, is not sufficient to provide a safe staple line. This assumption is debatable as companies have made an ongoing effort to improve surgical stapling safety and bariatric teams have greatly increased their LSG technical expertise in recent years.
Conversely, selective use of the SLR is mainly substantiated by low rate of bleeding and leaks in nonreinforced staple lines. Although a systematic review has shown rates close to 4% (3.27% for leaks and 4.94% for bleeding) in unreinforced staple lines, several studies based on a multicenter dataset repeatedly pointed to rates below 1%, with minimal differences between reinforced and nonreinforced staple lines [Table 2].,,,, Accordingly, SLR can be an excessive care for the vast majority of patients, which affects operative time and mainly final costs.
|Table 2: Postsleeve bleeding and leaks rates with and without staple-line reinforcement according to publications based on Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database|
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While oversewing is an affordable and widely available method, the major hindrances related to buttressing materials seems to be their low availability and greater impact on surgical costs, especially outside referral centers. Recent cost-effectiveness studies have been unfavorable for SLR use. Compared with nonbuttressed or oversewn (n = 27,349), patients with both absorbable and nonabsorbable buttressed staple line (n = 38,231) had slightly lower complication rates for bleeding and transfusion, but similar leak-rate and higher hospitalization costs. Similarly, bleeding and leak rates and 30-day treatment costs were pooled from patient records undergoing LSG from 2012 to 2018 registered in the MBSAQIP (n = 346,530) and Michigan Bariatric Surgery Collaborative (n = 9,476) database. Compared with standard nonreinforced stapling, reinforced stapling reduced minor postoperative bleeding but not major bleeding or leaks. The economic evaluation model used in the study suggested that SLR is not a cost-effective surgical strategy at the population level.
Bariatric surgeons should be aware that adding costs may hamper the spread of bariatric surgery, especially in underdeveloped and developing countries. Meticulous technique is cheaper, and can be as safe as the routine use of buttressing materials.
In addition, complications still occur despite the reinforcement methods. Technical mistakes such as diathermic damage during gastric dissection, improper selection of staple height according to tissue thickness, staple-line irregularities, setbacks related to the device itself such as the staples malformation, and patient's drawbacks such as defective healing processes are some examples of possible sources of complications that cannot be prevented simply using the SLR. A recently published systematic review assessing only randomized clinical trials compared several methods of SLR versus nonreinforcement in the setting of elective LSG. The meta-analysis (17 studies; 3,994 patients) showed that SLR was associated with significantly reduced postoperative bleeding and suggested a clinical trend toward reduced leakage. Predictably, longer operative time was associated with SLR methods. This review also showed that most surgeons perform the sleeve without any routine reinforcement (n = 1,641; 41.1%), presumably relying on stapler technology combined with proper surgical technique. Among the reinforcement methods, the suture oversewing (n = 1.507; 37.7%) was the most preferred choice, perhaps due to ready and wide availability.
Therefore, the best way to minimize complications related to the staple line is probably to pursue optimal staple-line construction, regardless of the SLR.
| Optimal Staple-Line-Surgical Standardization and Technical Tips|| |
In short, the optimal staple line is the one that provides and maintains an adequate tissue apposition with hemostasis, but without ischemia, ensuring both a tensile strength higher than intraluminal pressure and the natural evolution of the physiological healing process. Some factors favor the achievement of these goals in the LSG. First, stapling is usually performed on a healthy organ. Second, the tissues to be attached (anterior-posterior gastric wall) are quite similar, if not equal, which makes choosing the staple height an easier decision. Third, two main arterial branches perfuse the remaining stomach (the sleeve itself), ensuring sufficient blood supply for healing process.
Despite these favorable factors, achieving the optimal staple line can be undermined by technical conditions such as huge fatty liver and large visceral fat. In addition, inadequate healing process and hemostasis commonly associated with morbidly obese patients due to chronic inflammatory state and multiple comorbidities may also contribute to an increased risk of staple-line-related complications. In turn, improper staple closure, shot-locking or bad-cutting blade are infrequent source of device-related complications today, as cartridges with three interspersed rows of staples, different staple height options and blade electronic trigger have brought more safety and reliability to surgical staplers.
As such, training and surgical skills can be pivotal in producing a low-risk staple line. Considering that the stapling process appears to be a significant source of technical shortcomings in LSG, meticulous technical standardization along with some tips and tricks could be the difference between a low-risk and high-risk stapling line, regardless of the SLR.
First, surgeons need to be thoroughly familiar with the science of stapling. Due to the expansion of minimally invasive surgeries, stapling devices (including cartridges) have undergone unremitting evolution in recent years. Although desirable, such fast technological advancement came along a “collateral effect”: the educational gap in surgeons' understanding how these devices actually work. To increase staple line safety, bariatric surgeons should be broader mastery on concepts such as tissue compression, tissue-device interaction, stapler pressure, mechanical and biological properties of the tissues to be stapled, and acceptable staple formation.,,,
Proper selection of staple height across the stomach is a decision that requires not only technical standardization, but surgeon expertise and training, as the predicted tissue thickness may change in selected situations, such as conversion from adjustable gastric band or after the intragastric balloon. As a rule, the gastric wall thickness gradually decreases from antrum to fundus and from lesser to greater curvature. Moreover, the stomach seems to be thicker in male gender and super obese individuals. As there is still no intraoperative method to reliably measure gastric wall thickness, the available data are based on removed specimens (“in vitro”), after the entire stapling process has been finished.,,,,, Thus, choosing the most appropriate staple height for each situation remains somewhat empirical. In addition, buttressing material can add some thickness to the gastric tissue and require adjustments in the staple height previously established by the technical standardization.
Tissue compression by stapler jaws can provide thinner and more elongated gastric wall by fluid dislodgement, allowing smooth cutting and providing proper staple formation with lower tensile strength., Final tissue compression is time-dependent, as the manufacturer previously settles the compression force of the linear cutter stapler jaws. However, the need of prefiring time with the stapler in place and completely closed depends on the manufacturer's recommendations. Excessive time should be avoided, otherwise gastric wall tearing can occur.
The firing sequence will determine the final shape of the sleeve. Ideally, the final shape should resemble a long-sleeved shirt with a wider “shoulder” (antrum) and a narrow tip (near the esophagogastric junction). To get this goal, the first firings are the most important. In addition, special care must be taken with the second and the last firings to ensure a safe distance from the incisura angularis and the abdominal esophagus, respectively. A safe distance from the incisura angularis can prevent strictures and final hourglass appearance. Likewise, the distance from the abdominal esophagus is to assure that only gastric tissue has been trapped between the stapler jaws.
Throughout the entire stapling process, the device should only be fired at clear sight in a comfortable and secure positioning, after careful checking the anterior and posterior gastric wall. The surgeon must strive to avoid coarse tortuosity of the staple line due to trapping at different distances from the lesser gastric curvature. In addition, surgeons should try to build a real “line” instead of “stair treads.” Thus, after the first firing, the stapler jaws should ideally be placed in a position where the blade begins to cut between the two staple lines formed by the previous firing, avoiding overlap. After the second firing, “crotch” staple should always be searched and, if present, removed. During and after stapling process, fresh staple-line should not be stretched or tightly seized by laparoscopic graspers.
Some bleeding usually occurs along the newly created staple line during or shortly after the stapling process. Gentle mechanical compression pending the physiological coagulation cascade is generally sufficient in most cases. Surgical clips (used in cholecystectomies), punctual single absorbable stitch and hemostatic sealants - when available - can be safe alternatives in selective situations. The use of extensive monopolar energy should be discouraged because of increased risk of diathermic damage.
Finally, leak tests are neither predictive nor preventive for postoperative complications, but may highlight intraoperative staple-line failure, especially when the stapling was performed in adverse technical conditions.,,
Considering the patient with morbid obesity as an unpredictable and uncontrollable factor for complications, and the stapler device as quite safe and stable, the difference between a low-risk and high-risk staple line can be the meticulous surgical technique. Therefore, intensive and continuous efforts in training programs are likely to provide better outcomes than the nonjudicious application of SLR. After all, SLR does not seem to be the definitive relief for surgeons' concern about complications related to the LSG staple line.
| Conclusion|| |
Although conflicting, several studies have shown some advantages of SLR in preventing staple line-related complications, mainly bleeding. However, complications still occur regardless of reinforcement methods, which certainly fail to overcome critical technical deficiencies and/or surgical mistakes. Therefore, continuous training and technical improvement combined with in-depth knowledge of the science of stapling can provide a safer staple line on the LSG, regardless of reinforcement methods.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]