Endovascular Stapler Complications During Minimally Invasive Nephrectomy: An Updated Review of the FDA MAUDE Database From 2009-2019.

OBJECTIVE: To characterize the rates of endovascular stapler complications during hilar ligation in minimally invasive radical nephrectomy over the last 10 years. MATERIAL AND METHODS: We reviewed the Food and Drug Administration Manufacturer and User Facility Device Experience database from January 1, 2009 to August 1, 2019. Staplers were categorized according to type, namely Ethicon Inc. endocutters (Johnson & Johnson, New Brunswick NJ); Endo-GIA (Medtronic, Minneapolis MN); and Endo-TA (Medtronic, Minneapolis MN). RESULTS: There were 383 cases of complications involving staplers, 63% with Ethicon endocutters; 28% with GIA; and 9% with TA. 22 deaths (5.7% of total complications) were attributed to staplers. No deaths or reoperations occurred due to TA staplers. TA staplers were also associated with a reduced incidence of conversion to open as compared to Ethicon and GIA staplers. Apart from one device, manufacturer evaluation of returned devices either showed no abnormalities or attributed fault to improper use of staplers. DISCUSSION: We characterized stapler complications during a 10-year period for minimally invasive radical nephrectomy. No deaths or reoperations occurred due to TA staplers, perhaps due to cutting and stapling occurring in separate steps. Based on manufacturer evaluation attributing stapling malfunctions to human errors, training of operating room staff on proper use of these devices is critical to prevent potentially significant complications from occurring.

A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial).

BACKGROUND: Although distal pancreatectomy (DP) using a reinforced stapler is expected to reduce PF, no multicenter RCT has been performed. To investigate whether reinforced staplers reduce the incidence of clinically relevant pancreatic fistula (PF) after DP compared with staplers without reinforcement. METHODS: Between July 2016 and December 2017, patients scheduled for DP were enrolled in a multicenter, randomized, controlled trial (RCT) at nine hospitals in Hiroshima Japan. Patients were randomized either to reinforced stapler or bare stapler. The primary endpoint was incidence of clinically relevant PF. This RCT was registered with UMIN Clinical Trial Registry (UMIN000022341). RESULTS: A total of 122 patients were assigned to reinforced stapler (n = 61) or bare stapler (n = 61), and 119 patients (61 reinforced stapler and 59 bare stapler) were analyzed. There was no significant difference in the incidence of clinically relevant PF between the reinforced stapler and bare stapler groups (16.3% vs. 27.1%, p = 0.15). Furthermore, the rates of major complication (16.3% vs. 18.6%, p = 0.74), postpancreatectomy hemorrhage (0% vs. 3.4%, p = 0.08), and median postoperative in-hospital days (19 days vs. 20 days, p = 0.78) did not differ between the two groups. Within a subset of 82 patients in whom the thickness of pancreatic transection line was less than 14 mm, a significant difference was found in the incidence of clinically relevant PF (4.5% vs. 21.0% in the reinforced stapler vs. bare stapler groups, respectively, p = 0.01). CONCLUSIONS: Reinforced stapler for pancreatic transection during DP does not reduce the incidence of clinically relevant PF compared to stapler without reinforcement.

Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of Video-Assisted Thoracic Surgery Lobectomy Procedures: A Retrospective, Observational Study.

INTRODUCTION: Video-assisted thoracic surgery (VATS) lung resections are complex procedures with a critical role played by endoscopic staplers in the transection of vessels, bronchi, and lung tissue. This retrospective, observational study compared hospital resource use, costs, and complications of VATS lobectomy procedures for whom powered versus manual endoscopic surgical staplers were used. METHODS: Patients ≥ 18 years of age undergoing elective VATS lobectomy during an inpatient admission from January 1, 2012 to September 30, 2016 were identified from the Premier Healthcare Database (first admission = index admission). Use of either powered or manual endoscopic staplers during the index admission was identified from hospital administrative records. Multivariable regression analyses adjusting for patient, hospital, and provider characteristics and hospital-level clustering were carried out to compare the following outcomes between the powered and manual stapler groups: hospital length of stay (LOS), operating room time (ORT), hospital costs, complications (bleeding and/or transfusions, air leak complications, pneumonia, and infection), discharge status, and 30-, 60-, and 90-day all-cause readmissions. RESULTS: The powered and manual stapler groups comprised 659 patients (mean age 66.1 years; 53.6% female) and 3100 patients (mean age 66.7 years; 54.8% female), respectively. In the multivariable analyses, the powered stapler group had shorter LOS (4.9 vs. 5.9 days, P < 0.001), lower total hospital costs ($23,841 vs. $26,052, P = 0.009), and lower rates of combined hemostasis complications (bleeding and/or transfusions; 8.5% vs. 16.0%, P < 0.001) and transfusions (5.4% vs. 10.9%, P = 0.002), compared with the manual stapler group. Other outcomes did not differ significantly between the study groups. Similar trends were observed in subanalyses comparing devices across predominant manufacturers in each group, and in subanalyses of patients with comorbid chronic obstructive pulmonary disease. CONCLUSION: In this analysis of VATS lobectomy procedures, powered staplers were associated with significant benefits with respect to selected types of hospital resource use, costs, and clinical outcomes when compared with manual staplers. FUNDING: Johnson & Johnson.

Early complications after stapled hemorrhoidopexy: a retrospective study comparing three different circular staplers.

BACKGROUND: A retrospective analysis was performed to assess differences between three devices used for stapled hemorrhoidopexy (SH) in terms of early complications and complaints and the volume of excised tissue. MATERIALS AND METHODS: All patients who underwent an elective SH from January 2008 to December 2014 were included. Three different devices were used: the PPH03 stapler (Ethicon EndoSurgery, Diegem, Belgium) and the ChexTM CPH32 and CPH34 staplers (Frankenman International Ltd, Hong Kong, China). The demographic data were reviewed as well as indications for surgery. The volume of the excised tissue was determined by reviewing the anatomopathologic reports. We assessed early postoperative complications and complaints and compared the rate of complications between the three used devices. RESULTS: From 1 January 2008 to 30 December 2014, 253 patients underwent a SH using three different devices. One hundred and seventy-four patients were treated with the PPH03 stapler, 51 with the ChexTM CPH32 stapler and 28 with the ChexTM CPH34 stapler. Postoperatively, 28.5% of patients experienced minor early complications. There was no difference in complication rates between the three different devices, except for the occurrence of postoperative stenosis with more stricture formation when using the CPH32 stapler (p < 0.0001). The volume of tissue excised by the ChexTM CPH32 and CPH34 staplers was significantly larger than in the PPH03 group (18.19 ± 9.67 mL; 25.53 ± 13.99 mL; 11.63 ± 5.66 mL; p < 0.0001). CONCLUSIONS: Postoperative anal stenosis was more common after circular stapled hemorrhoidopexy with the ChexTM CPH32 stapler.

Revisäo da técnica das suturas mecânicas do aparelho digestivo / Review of mechanic suture in gastrointestinal system

Os autores fazem um estudo a respeito das técnicas de sutura mecânica no aparelho digestivo desde o seu surgimento até os dias atuais. Apresentam aspectos históricos da sutura mecânica bem como os tipos de aparelhos utilizados para as suturas de aparelho digestivo. São feitos comentários das desvantagens, bem como de suas complicações

Surgical staplers: a review.

For almost two centuries, surgeons have been using mechanical devices to join tissue. One of the most successful methods is that of stapling, which has become very common in more recent times. The range of staplers consists of five established stapler categories (circular, linear, linear cutting, ligating and skin staplers), along with recent variations which lend themselves to minimally invasive surgery. Within each category, several commercial models are available, many of which have their own unique features. The procedures which are enhanced by these instruments are many and varied. Applications have been further expanded and improved by the instrument design developments seen in recent years. This review attempts to present a rationalized overview of the array of stapling instruments, with relevant procedures. The authors believe that surgical stapling may be greatly enhanced by further research and development, taking the instrument designs and procedures further into the realm of minimally invasive surgery.

Different techniques for creating oesophageal anastomoses. A historical review and personal experience.

UNLABELLED: Among the surgical techniques used to create a reliable oesophageal anastomosis, mention should be made of the handmade (in one or two layers, wire or Vicryl) and the different stapler anastomoses. 41 oesophageal anastomoses were performed by stapler technique between 4 March 1985 and 4 March 1991. The EEA stapler was used in 15, and the SPTU stapler in 26 patients. The average age was 56.8 years overall, 53.6 in the female (7 patients) and 57.4 years in the 34 male patients. Tumours in the middle and lower third of the oesophagus and on the cardia were the indications for resection in 30 instances. Total gastrectomy was performed in 9 patients and oesophageal resection for peptic stricture in 2 cases. Replacement with stomach was carried out after oesophageal resection (17 patients), and with Roux-loop in 24 cases. The EEA anastomoses were not covered by a hand-made layer of interrupted sutures as is compulsory in the case of the SPTU gun. The intraoperative complication rate was 12.2%--two severe complications with the SPTU and 3 mild ones with the EEA (2 cases) and SPTU (1 case) machines. The postoperative complication rate was 17%--the severe ones with the SPTU gun. The only fatal anastomosis insufficiency was observed in this group. 3 of the 41 patients died--a mortality rate of 7.3%--but only one of them was due to technical failure in the SPTU group: 2.4%. CONSEQUENCES: Both the intra- and postoperative complications were more severe with the SPTU technique. The early postoperative complications are closely related to the intraoperative ones. Mortality due to technical failure was only observed in the SPTU group. The EEA stapler gun is superior in every respect to the SPTU sewing-machine. The future belongs to the even more sophisticated bent and modifiable devices. These were used in our Department Between 1992 and 1997, with practically no morbidity and no mortality. Although they are the most expensive of all the possibilities, the low morbidity and mortality rates pay off from the aspects of the short hospital stay and the savings in human life.

Partial splenic resection using the TA-stapler.

Since 1987, we have used the TA-stapler for 15 partial resections of the spleen. The cases included 5 second- to third-degree traumatic ruptures, 4 splenic cysts, 3 injuries resulting from accidents during upper-abdominal surgery, 2 diagnostic resections, and 1 intralienal pancreatic cyst. The TA-55 stapler was used 14 times and the TA-90 once. No patient developed postoperative bleeding or required further surgery. Postoperative laboratory chemistry and scintigraphy findings were within the limits indicative of normal function in all cases. The TA-stapler expands the technical possibilities for organ-conserving splenic surgery.