Safety and Feasibility of a Lower-Cost Stapler in Bariatric Surgery.

BACKGROUND: Laparoscopic staplers are integral to bariatric surgery. Their pricing significantly impacts the overall cost of procedures. An independent device company has designed a stapler handle and single-use reloads for cross-compatibility and equivalency with existing manufacturers, at a lower cost. OBJECTIVES: We aim to demonstrate non-inferior function and cross-compatibility of a newly introduced stapler handle and reloads compared to our institution's current stapling system in a large animal survival study. SETTING: University-affiliated animal research facility, USA. METHODS: Matched small bowel anastomoses were created in four pigs, one with each stapler (a total of two per animal). After 14 days, investigators blinded to stapler type evaluated the anastomoses grossly and microscopically. Each anastomosis was scored on multiple measures of healing. Individual parameters were added for a global "healing score." RESULTS: Clinical stapler function and gross quality of anastomoses were similar between stapler groups. Individual scores for anastomotic ulceration, reepithelialization, granulation tissue, mural healing, eosinophilic infiltration, serosal inflammation, and microscopic adherences were also statistically similar. The mean "healing scores" were equal. While this study was underpowered for subtle differences, safe and reliable performance in large animals still supports the feasibility of introducing new devices into human use. CONCLUSIONS: The new stapler system delivers a similar technical performance and is cross-compatible with currently marketed stapling devices. An equivalent quality device at a lower price point should enable case cost reduction, helping to maintain hospital case margin and procedure value in the face of potentially declining reimbursement. This device may provide a safe and functional alternative to currently used laparoscopic surgical staplers.

Using the Hand-Sewn Purse-String Stapled Anastomotic Technique for Minimally Invasive Ivor Lewis Esophagectomy.

BACKGROUND: Minimally invasive Ivor Lewis esophagectomy (MIILE) is increasingly being used in the treatment of middle or lower esophageal cancer. Hand-sewn purse-string stapled anastomosis is a classic approach in open esophagectomy. However, this procedure is technically difficult under thoracoscopy. The hardest part is delivering the anvil into the esophageal stump. Herein, we report an approach to performing this step under thoracoscopy. METHODS: A total of 257 consecutive patients who underwent MIILE between April 2013 and July 2017 were analyzed retrospectively. The operator hand sewed the purse string using silk thread under thoracoscopy, and the 25-mm circular stapler was passed through the anterior axillary line at the fourth intercostal space to finish the side-to-end gastroesophageal anastomosis. Patient demographics, intraoperative data, postoperative complications were evaluated. RESULTS: The mean operative time, thoracoscopy time, and anvil fixation time was 307.0 ± 34.3, 155.4 ± 21.5, and 7.1 ± 1.6 minute, respectively. The anastomotic leak and anastomotic stricture occurred in 6.6% (17 of 257) and 3.9% (10 of 257) of patients, respectively. There was no intraoperative death; one case was death of acute respiratory distress syndrome (ARDS) for conduit gastric leakage on the 21st postoperative day. CONCLUSION: Using the hand-sewn purse-string stapled anastomotic technique for MIILE is feasible and relatively safe in patients with middle or lower esophageal cancer.

Current role of staple line reinforcement in 30-day outcomes of primary laparoscopic sleeve gastrectomy: an analysis of MBSAQIP data, 2015-2016 PUF.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has become a dominant bariatric procedure. In the past, significant leak rates prompted the search for staple line reinforcement (SLR) techniques. Previous analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database for all LSG suggested a detrimental influence of SLR on leak rates and overall morbidity. OBJECTIVE: To investigate the relationship between various SLR techniques and bougie size with 30-day outcomes. SETTING: Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited bariatric surgery hospitals. METHODS: Using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program 2015 to 2016 Participant Use File data, primary LSG cases were divided into study groups based on surgical techniques. All variables were reported in the Participant Use File except leak rate and overall morbidity, which had to be derived. Multiple bivariate analyses were used to analyze the 30-day outcomes. RESULTS: A total of 198,339 primary LSG operations were included and grouped into No SLR (23.0%), SLR (54.2%), oversewn staple line (9.5%), and a combination of SLR + oversewn staple line (13.3%). There were no statistical differences between study groups in mortality, overall morbidity, or leak rate. Bleeding and reoperation rates were statistically higher in the No SLR group. Bougie size was not associated with change in leak rates. CONCLUSION: Primary LSG is a safe procedure with low morbidity and mortality rates. SLR is associated with decreased rates of bleeding and reoperations but does not affect leak rates. The selection of SLR technique should be left to the surgeon's discretion with an understanding of the associated risks, benefits, and costs.

Outcomes of a novel intrathoracic esophagogastric anastomotic technique.

OBJECTIVES: Anastomotic complications represent a significant source of morbidity and occasionally mortality after esophagectomy. Since 2009, we have used a novel "side-to-side: staple line-on-staple line" (STS) technique for intrathoracic esophagogastric anastomoses, designed to create a wide-diameter esophagogastric anastomosis while preserving stomach conduit blood supply. In this study, we describe the technique and review outcomes of our institution's initial 6-year experience. METHODS: An institutional database query identified 278 consecutive patients who underwent Ivor Lewis esophagogastrectomy using an STS esophagogastric anastomotic technique from 2009 through 2015. A retrospective review was conducted to assess outcomes with a focus on anastomotic complications. RESULTS: There were a total of 8 (2.9%) anastomotic leaks in patients who underwent STS esophagogastric anastomosis, 3 of which were grade I/II leaks and required no intervention. There was a leak rate of 6.3% (2 of 32) after esophagectomy for benign conditions (both leaks occurring in 8 total patients (25%) who received surgery for end-stage achalasia) compared with a 2.4% leak rate (6 of 246) in whom esophagectomy was performed for malignancy (P = .22). Fourteen patients (5.0%) required a median of 2 dilatations for anastomotic stricture after STS anastomosis. Supplemental jejunostomy feedings were required in only 11.1% of these patients after hospital discharge. CONCLUSIONS: We believe this novel STS technique provides excellent results with respect to the incidence of intrathoracic esophagogastric anastomotic leak and stricture after esophagectomy. Additionally this technique has significantly reduced the need for enteral feeding after hospital discharge.

Predictors of complications and mortality following left colectomy with primary stapled anastomosis for cancer: results of a multicentric study with 1111 patients.

AIM: Reports detailing the morbidity-mortality after left colectomy are sparse and do not allow definitive conclusions to be drawn. We aimed to identify risk factors for anastomotic leakage, perioperative mortality and complications following left colectomy for colonic malignancies. METHOD: We undertook a STROBE-compliant analysis of left colectomies included in a national prospective online database. Forty-two variables were analysed as potential independent risk factors for anastomotic leakage, postoperative morbidity and mortality. Variables were selected using the 'least absolute shrinkage and selection operator' (LASSO) method. RESULTS: We analysed 1111 patients. Eight per cent of patients had a leakage and in 80% of them reoperation or surgical drainage was needed. A quarter of patients (24.9%) experienced at least one minor complication. Perioperative mortality was 2%, leakage being responsible for 47.6% of deaths. Obesity (OR 2.8, 95% CI 1.00-7.05, P = 0.04) and total parenteral nutrition (TPN) (OR 3.7, 95% CI 1.58-8.51, P = 0.002) were associated with increased risk of leakage, whereas female patients had a lower risk (OR 0.36, 95% CI 0.18-0.67, P = 0.002). Corticosteroids (P = 0.03) and oral anticoagulants (P = 0.01) doubled the risk of complications, which was lower with hyperlipidaemia (OR 0.3, P = 0.02). Patients on TPN had more complications (OR 4.02, 95% CI 2.03-8.07, P = 0.04) and higher mortality (OR 8.7, 95% CI 1.8-40.9, P = 0.006). Liver disease and advanced age impaired survival, corticosteroids being the strongest predictor of mortality (OR 21.5, P = 0.001). CONCLUSION: Requirement for TPN was associated with more leaks, complications and mortality. Leakage was presumably responsible for almost half of deaths. Hyperlipidaemia and female gender were associated with lower rates of complications. These findings warrant a better understanding of metabolic status on perioperative outcome after left colectomy.

Adverse events of lung tissue stapling in thoracic surgery.

PURPOSE: The use of staplers for thoracic surgery has been regarded as a safe procedure though sometimes adverse events (AEs) of stapling are experienced. The aim of this study is to analyze AEs of lung tissue stapling. METHODS: A retrospective multi-institutional review was conducted by 27 institutions of the Central Japan Lung Cancer Surgery Study Group. During the research period, lung tissue stapling was performed 10908 times. RESULTS: Total number of AEs related to stapling was 81 (0.74%). Seventy events occurred intraoperatively and 11 events occurred postoperatively. Intraoperative stapling AEs were air leakage (n = 26), laceration of the adjacent lung tissue (n = 23), stapling failure (n = 14), oozing (n = 4), and others (n = 3). The postoperative AEs were prolonged air leakage (n = 9), bleeding from the chest wall (n = 1), and postoperative bleeding (n = 1). Only one case died of acute exacerbation of interstitial pneumonia which was induced after completion lobectomy to cure postoperative bleeding. No relationship was seen between the incidence of AE and cartridge colors or compression types of staplers except the length of cartridges. CONCLUSION: Lung tissue stapling in thoracic surgery was safe. The most frequent cause of AEs was stapler-tissue thickness mismatch. The appropriate selection of the cartridge color may decrease the AE incidence of the lung tissue stapling.

Suprahilar vascular control and stapling device transection of Glissonian pedicle in major and minor hepatectomies.

BACKGROUND/AIMS: In this study we analyzed our experience of suprahilar-posterior intrahepatic Glissonian pedicle approach using an endo-GIA vascular stapling device for the pedicle and hepatic vein division. METHODOLOGY: Sixty-eight 68 major and 102 minor liver resections were performed. The hilar extrahepatic structures remain intact, and during parenchyma dissection by CUSA, the whole right or left or the appropriate segmental pedicle was isolated intrahepatically and then transected using a stapler device. RESULTS: The minor liver resections was associated with significantly shorter surgery duration (95.1 + 31.1 vs. 186.6 +/- 56.5) and transection time (35.9 +/- 14.5 vs. 65.3 +/- 17.2) than major hepatectomies (p < 0.001 for all). The mean blood loss was 255.6 + 129.9 mL in minor resection and 385.7 + 200.1 mL in major resection (p = 0.003). The mean blood transfusion requirement was 300.8 + 99.5 mL for the patients with minor hepatectomy and 450.9 + 89.6 mL for those with major liver resection (p = 0.067). There was no significant difference in morbidity and mortality between the groups (p = 0.989; p = 0.920). Major as well as minor liver resection were a superior oncologic operation with no significant difference in the 3-year overall survival rates. CONCLUSIONS: Liver transection using CUSA with suprahilar endo-GIA stapling of Glisson's pedicle, as well as major hepatic veins represents an effective and safe surgical procedure.

Reducing the gastroesophageal reflux with lip-type reinforcement technique during intrathoracic esophagogastrostomy.

BACKGROUND/AIMS: Gastroesophageal reflux is a significant problem after esophagogastrostomy, and impact considerably upon the quality of patients' lives. Aims of this study were to evaluate the operative effects in prevention of reflux with lip-type reinforcement during intrathoracic esophagogastric anastomosis. METHODOLOGY: From January 2005 to December 2009, 216 patients received circular stapled esophagogastrostomy with lip-type reinforcement (LR group), and 69 patients with standard reinforcement (SR group) at our hospital. Major observation parameters were symptoms of reflux and dysphagia. RESULTS: No differences in clinicopathologic characteristics between two groups, in addition to the incidence of anastomotic leakage was less in LR group (p = 0.039). Grade of dysphagia and anastomotic stricture also were not different between two groups (p >0.05). Symptoms of reflux were better controlled in patients with lip-type reinforcement than standard reinforcement (p <0.001). In LR group, 71.3% were asymptomatic with respect to reflux compared to 29.7% in SR group (p <0.001). The incidence of reflux esophagitis was 23.5% in LR group and 58.3% in SR group (p <0.001). There was a significant correlation between reflux symptoms and endoscopic findings of reflux esophagitis (p = 0.001). CONCLUSIONS: Lip-type reinforcement is simple to perform, and effective in controlling gastroesophageal reflux and decreasing anastomotic leakage in majority of patients after esophagogastrostomy.

Pancreatoenteral anastomosis or direct closure of the pancreatic remnant after a distal pancreatectomy: a single-centre experience.

BACKGROUND: A major complication of a distal pancreatectomy (DP) is the formation of a post-operative pancreatic fistula (POPF). In spite of the utilization of numerous surgical techniques no consensus on an appropriate technique for closure of the pancreatic remnant after DP has been established yet. The aim of this study was to analyse the impact of pancreatoenteral anastomosis (PE) vs. direct closure (DC) of the pancreatic remnant on POPF. METHODS: A total of 198 consecutive patients who underwent a distal pancreatectomy between 2002 and 2010 at our institution were retrospectively analysed for post-operative morbidity and mortality. RESULTS: One hundred and fifty-one patients (76.3%) received DC whereas PE was performed in 47 patients (23.7%). The incidence of POPF was higher in the DC group (22% vs. 11%), whereas the rate of post-operative haemorrhage was higher in the PE group (11% vs. 7%). However, these differences were not significant. Additionally, there were no significant differences in overall post-operative morbidity and mortality between the groups. CONCLUSIONS: The performance of PE instead of DC may be considered as a safe alternative in individual patients, but it does not significantly lead to a general improvement in post-operative outcome after DP. An interdisciplinary collaboration in the prevention and treatment of POPF therefore remains essential.

Mortality and anastomotic leakage after anterior resection for rectal cancer.

BACKGROUND/AIMS: The aim of the study was to analyze the mortality and symptomatic anastomotic leak following stapled anastomosis after anterior resection for rectal cancer. METHODOLOGY: We analyzed retrospectively 161 patients subjected to elective anterior resection of the rectum. There were 102 (63.3%) men and 59 (37.7%) women. The patients were divided into two groups according to tumor location: group I - 129 (80.1%) patients with tumor located >6 cm from the anal verge and group II - 32 (19.9%) patients with tumor located =6 cm. RESULTS: Anastomotic leak was found in 5 (3.1%) patients, three (2.3%) from group I and two (6.2%) from group II (p<0.26). Anastomotic leak was found more often in patients with renal failure (p<0.0023) and in those who had undergone RBC concentrate transfusion (p<0.0045). Seven (4.3%) patients died in the postoperative period. Deaths occurred more frequently in patients with valvular heart disease (p<0.00002), renal failure (p<0.0047) and in those given concentrates of RBC (p<0.045). CONCLUSIONS: Incidence of postoperative surgical complications after resection for rectal cancer is not high and is acceptable; however, there is an increased risk of leakage after low anterior resection. Renal failure as well as RBC concentrate transfusion have an influence on mortality and anastomotic leak.

[Possibilities of videothoracoscopic pulmonary resection in thoracic surgery].

The experience of videothoracoscopic pulmonary resection performance in various diseases in 183 patients was summarized. The methods of endoscopic and videoassisted pulmonary resection, including those conducted for peripheral cancer, using home-made and foreign suture apparatuses, were depicted. The indications were adduced for performance of diagnostic and curative videothoracoscopic operations, possibilities of their application, advantages in comparison with open operative procedures were adduced.

Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration.

BACKGROUND: Use of stapling devices has become standard practice in many operations, and these devices have many applications, including ligation and division, resection, anastomosis, and fascial closure. The Food and Drug Administration (FDA) regulates surgical staplers as a medical device. Manufacturers and health-care providers report adverse events occurring during the use of surgical staplers to the FDA. STUDY DESIGN: Two FDA adverse event databases, the Manufacturer and User Facility Device Experience database and the Alternative Summary Reporting database were searched for adverse events related to the use of surgical staplers. An FDA recall database, Oracle System Center Automated Retrieval, was searched for surgical stapler recalls and the reason for these recalls. RESULTS: We characterized adverse events from 112 death, 2,180 injury, and 22,804 malfunction reports from FDA adverse event databases. We described 22 recalls for these products that are listed in an FDA database. A majority of these recalls were related to manufacturing or design problems. CONCLUSIONS: The overall incidence of these events remains unknown; because these products are used so frequently, even uncommon adverse events may affect many patients. It is important for health-care providers to report adverse events to manufacturers so that they may work to improve the design of these devices and reduce use errors that contribute to the events.

[Mechanical digestive system suturing devices]. / Suturile digestive mecanice.

Between 1994 (December)-1996 (May) 150 patients have been operated on using one or many stapling devices. The staplers disposable to us were the "Linear Cutter" or GIA (Gastrointestinal Anastomosis), "Linear Stapler" (TA) and "Intraluminal Circular Stapler" or EEA (end-to-end anastomosis) types, produced by ETHICON (Johnson and Johnson Ltd. Company). The principles operations performed were various digestive resections, intervisceralis anastomosis and interventions of reconstructions (in oesophagus surgery, ileal pouch etc.). The advantages of staplers applications are: a) the reduction of the time of operation, of the anesthesia, of the blood loss; b) a soft manipulation of the tissues; c) a smaller inflammatory reaction and the prevention of intraoperative septic contamination and d) a better and faster take back of the functionality of the anastomosis. There were only 4 intraoperative haemorrhages easy controllable. Postoperative complications: a) 3 haemorrhages medically treated; b) immediate leakage 1 patient after colorectoanastomosis, treated by Hartman colostomy; precocious, 7 patients and after 4-6 month, 2 patients. Corrective iterative interventions were necessary only in 5 patients. The operative mortality-1 patient, the cause of death being a bronhopneumonia after a radical oesophagectomy with oesophagoplasty (oesophageal cancer). There was not postoperative mortality depending of stapling application. We don't observed late postoperative complications like stenosis of various anastomosis, quoted in the literature, because the time of following of our 150 patients is too short (maximum 18 months). The conclusions are that the stapling devices are a real surgical progress with the conditions of a correct indication and adequate tactics and operative technique. The economical effort is justified and entirely compensated by the major benefits obtained for the patients.

Single and double stapled anastomoses in rectal cancer surgery; a retrospective study on the safety of the technique and its indication.

Low anterior resection is commonly believed the main indication to double stapled (DS) technique, because placing the purse-string suture on the distal rectum is difficult or impossible. This study was designed to figure out the safety of the DS technique and to better define its role in rectal cancer surgery. The data of 34 patients that had a DS anastomosis were retrospectively compared to those of 43 that had a single-stapled (SS) anastomosis after anterior resection. Three deaths after SS (7%) and one after DS procedures (3%) were recorded (p = 0.62). Rates of clinical leaks were 12% (four cases) in the DS group and 14% (six cases) in the SS group (p = 0.41). The mean distance of the rectal tumour from the anal verge was significantly lower for DS (mean = 7.7 cm) respect to SS (mean = 12.7 cm) anastomoses (p < 0.0001) and the blood consumption at surgery was significantly greater in patients that had DS (mean = 375 ml) compared to SS-anastomoses (mean = 180 ml) (p = 0.028). Thus, the DS technique was mostly used in patients at high risk for leakage. The study shows that DS technique is a safe and reliable method to perform colorectal anastomosis after anterior resection for cancer. For cancers located in the upper rectum the routine adoption of the DS increases the cost of surgery and does not offer advantages over the SS technique with the exception of making feasible end-to-end mechanical anastomoses involving bowel segments having different diameters.

Colorectal stapled anastomoses. Experiences and results.

PURPOSE: Stapled anastomoses are currently an established technique in colorectal surgery. Larger series about the use of circular staplers in rectal anastomoses within daily clinical routine are rare. METHODS: We evaluated the morbidity, clinical leakage rate, and mortality in an unselected population of a teaching hospital after elective, left-sided colorectal resections with stapled rectal anastomoses. In the course of our study, manually sewn rectal anastomoses were not performed. All anastomoses were tested intraoperatively by instillation of liquid. RESULTS: A total of 615 elective colorectal resections with stapled rectal anastomoses was performed by 18 surgeons from 1984 to 1993. A protective colostomy was created in 2.9 percent (n=16) of all patients. Clinical anastomotic leakage occurred in nine patients (1.5 percent). The mortality rate was 1 percent (n=6). CONCLUSION: Use of the stapling technique facilitates the performance of anastomoses, particularly in regions with difficult anatomy. The rate of local complications is low, and protective colostomy can thus be dispensed with in most cases