Literature Review on the Incidence of Primary Stapler Malfunction.

Background. Surgical stapling devices are known for their reliability and convenience. A letter to health care professionals published by the US Food and Drug Administration in March 2019 highlighted the increasing number of adverse events associated with surgical staplers. Driven by a case of stapler malfunction during an elective laparoscopic sleeve gastrectomy, we performed a literature review to investigate the incidence of primary stapler malfunction. We also discuss the common types and an approach to its management. Methods. PubMed, MEDLINE, and EMBASE databases were searched for articles discussing surgical stapler malfunction. Twelve studies were selected that described the incidence and/or consequences of primary stapler malfunction. A narrative synthesis was performed. Results. From observational studies, the incidence ranged from 0.022% to 2.3%. A prospective survey reported that 86% of laparoscopic surgeons either had personal experience with or knew of surgeons who experienced stapler malfunction, implying a higher incidence. Underreporting has been an issue as manufacturers can get exemptions from public reporting. Significantly, higher malfunctions have been reported after exemptions were lifted. The most common types of stapler malfunction are stapler misfire and stapler locking. Major morbidity and mortality have been reported. Conclusion. Surgeons are increasingly reliant on technological innovations. Stapling failure occurs and it is imperative to be aware of this. Given the high volume of stapler use, a high percentage of surgeons are likely to encounter this problem in their career. It is important to have an approach to the prevention and management of this potentially catastrophic complication.

Appendectomy in Switzerland: how is it done?

More than 10,000 appendectomies are performed every year in Switzerland. The aim of this study was to investigate the treatment strategy for appendicitis among Swiss surgeons with particular interest in laparoscopic technique, method of appendiceal stump closure, and abdominal lavage. We performed an anonymous survey among 540 members of the Swiss Surgical Society. Technical details and differences between the surgical procedures in adults and children as well as in complicated and non-complicated appendicitis were investigated. The overall response rate was 45% (n = 243). 78% of the surgeons perform laparoscopic appendectomies in children and 95% in adult patients. Only 3% use a single incision site technique. Surgeons consider pus or stool in the abdomen (94%), an abscess (86%) or perforation of the appendix (82%), but not an inflamed appendiceal base (16%) as complicated appendicitis. 41% of surgeons use endoloops, 36% a stapling device, and 20% polymeric clips in non-complicated appendicitis for appendiceal stump closure. However, 82% of the surgeons use a stapler in complicated appendicitis. Most (76%) of surgeons do not plunge the appendiceal stump. 24% of surgeons lavage the abdomen with > 1 L of fluid independent of the intraabdominal finding. Most Swiss surgeons perform multiport laparoscopic appendectomies. Endoloops and staplers are mostly used for appendiceal stump closures in uncomplicated appendicitis, and staplers in complicated appendicitis. Only a minor part of surgeons plunge the appendiceal stump or perform routine abdominal lavage.

The Impact of Circular Stapler Size on the Incidence of Cervical Anastomotic Stricture After Esophagectomy.

BACKGROUND: Cervical anastomotic stricture after esophagectomy is a serious complication that adversely affects postoperative recovery, nutritional status and quality of life. Cervical anastomosis by a circular stapler (CS) has been widely accepted as a simple and convenient method, but anastomotic strictures are likely to occur. The aim of this study was to investigate an association between CS size and the incidence of anastomotic stricture after cervical esophagogastric anastomosis performed by a CS. METHODS: Between April 2011 and March 2016, 236 consecutive patients underwent cervical esophagogastric anastomosis by a CS via a retrosternal route after esophagectomy for esophageal cancer. These patients were divided into according to CS size for the procedure as follows: small-sized (25 mm) CS group (SG, n = 116) and large-sized (28 or 29 mm) CS group (LG, n = 120). The clinical data of patients were analyzed retrospectively to compare the two groups. RESULTS: Overall, anastomotic strictures were observed in 90 patients (38%). The incidence of anastomotic stricture was significantly lower in the LG than the SG (23% vs. 53%, p < 0.001) (Table 3). Chronic obstructive pulmonary disease (COPD: FEV1.0% <70%) (OR 2.35, 95% CI = 1.09-5.14; p = 0.029), anastomotic leakage (OR 8.97, 95% CI = 2.69-41.30; p < 0.001), and a small-sized CS (OR 3.42, 95% CI = 1.82-6.62; p < 0.001) were independent risk factors for anastomotic stricture in the multivariate analysis. CONCLUSIONS: If possible, a large-sized CS should be used to prevent cervical anastomotic strictures when performing cervical anastomoses by CS.

The Use of Robotic and Laparoscopic Surgical Stapling Devices During Minimally Invasive Colon and Rectal Surgery: A Comparison.

PURPOSE: To date there exists no published study examining the safety and efficacy of the EndoWrist 45 (Intuitive Surgical, Inc.) robotic stapler. We compared outcomes between the robotic and comparable laparoscopic stapler in robotic-assisted colorectal procedures. MATERIALS AND METHODS: We conducted a retrospective review of 93 patients who underwent robotic-assisted colorectal surgery at our institution from 2012 to 2014. Surgeries included left, sigmoid, subtotal and total colectomies, and low anterior rectal resections. Indications were malignancy and diverticular and inflammatory bowel disease. Preoperative demographics, intraoperative data, and postoperative outcomes were examined. Student's t-test and Fischer's exact used were appropriate. RESULTS: Forty-five millimeters laparoscopic staplers were used in 58 cases, while the 45 mm robotic stapler was used in 35 cases. There was no difference in age (P = .651), gender (P = .832), or body mass index (P = .204) between groups. There was no difference in estimated blood loss (P = .524), operative time (P = .769), length of stay (P = .895), or complication rate (P = .778). The robotic stapler group had one anastomotic leak, while the laparoscopic stapler group had six (P = .705). There were more laparoscopic stapler fires (2.69) per patient than robotic stapler fires (1.86) (P = .001). The cost per patient for the laparoscopic group was $631.45 versus $473.28 for the robotic group (P = .001). CONCLUSION: This is the first study to evaluate the robotic stapler. Advantages of the robotic stapler include large range of motion and 90° of articulation, which may provide a benefit when using the stapler in difficult areas like the pelvis. The robotic stapler has a comparable level of safety as a 45 mm laparoscopic stapler and is more cost effective.

Extended Low Anterior Resection with a Circular Stapler in Patients with Rectal Cancer: a Single Center Experience.

BACKGROUND: to evaluate the outcome of stapled colo-anal anastomoses after extended low anterior resection for distal rectal carcinoma. MATERIALS AND METHODS: A retrospective study of fifty patients who underwent colo- anal anastomoses after extended low anterior resection was conducted at Imam Hospital from September 2007 up to July 2012. RESULTS: The distance of the tumor from anal verge was 3 to 8 cm. Anastomotic leakage developed in 6% of patients and defecation problems in 16% . One-year local recurrence was 6% while three-year local recurrence was 4%. One-year systemic recurrence was seen in 22% while three-year systemic recurrence was seen in 20%. CONCLUSIONS: Colo-anal anastomoses after extended low anterior resection for distal rectal carcinoma can be conducted safely.

Proximal anastomosis using the OrVil circular stapler in major upper gastrointestinal surgery.

Anastomoses in major upper gastrointestinal surgery can be technically demanding, especially handsewn anastomoses traversing the diaphragmatic hiatus. The OrVil stapler is a unique circular stapler that allows rapid creation of various upper gastrointestinal anastomoses in technically challenging circumstances, particularly if additional proximal clearance is desirable. Little is reported in the literature regarding its outcomes and complication rates. In this 'How I do It' article, we describe our technique and experience with the OrVil in major upper gastrointestinal surgery.

Ergonomic evaluation of a mechanical anastomotic stapler used by Japanese surgeons.

PURPOSE: The satisfaction rating of currently available mechanical staplers for Japanese surgeons with small hands is low. To identify the issue, we examined the relationship of hand dimensions and grip force with the operation force of a mechanical circular stapler. METHODS: Hand dimensions and grip force were measured in 113 Japanese surgeons (52 men and 61 women). We then evaluated the relationship between grip width and the operation force required to push the lever of the stapler, at three points on the lever, using a digital force gauge. RESULTS: The optimal grip width of the dominant hand was 62.5 ± 8.5 mm for men and 55.5 ± 5.9 mm for women (p < 0.001). The maximum grip force of the dominant hand was 44.2 ± 6.1 kg for men and 29.7 ± 4.5 kg for women (p < 0.001) and the maximum operation force required to push the lever 7.0, 45.0, and 73.0 mm from the end of the lever was 21.8, 28.6, and 42.4 kg, respectively. CONCLUSIONS: To our knowledge, this is the first ergonomic study of a surgical stapler to be conducted in Asia. Firing the stapler by gripping the proximal side of the lever is physically impossible for most Japanese women surgeons since the required operation force exceeds the maximum grip force, which probably accounts for the stress perceived by these women.

The effect of a focused instructional session on knowledge of surgical staplers in general surgery residents.

INTRODUCTION: Surgical stapling devices have been used for a variety of purposes in both laparoscopic and open surgery. Nevertheless, trainees rarely receive any focused instruction on their application and use. This study attempts to determine the baseline knowledge of surgical stapling devices possessed by surgical residents. Furthermore, we attempt to evaluate the effectiveness of a short didactic session in improving the trainee's knowledge of the use and function of surgical staplers. METHODS: A 20-question multiple-choice test was created to evaluate a general surgery resident's knowledge on the design and use of circular, linear, and laparoscopic surgical staplers. The test was administered before and after attending a 40-minute instructional session on surgical stapling devices. The tests were then scored by a data analyst. RESULTS: A total of 26 residents of 39 in the residency program (26/39, 67%) participated. The pretest mean was 10.62/20 (53%), whereas the posttest mean was 15.38/20 (77%). These results were significantly different on paired samples t-test analysis (t((25)) = -10.3; p < 0.05). The mean pretest scores were also significantly different between resident levels (R1-R2, 9.50; R3-R5, 11.31; t((24)) = -2.10; p < 0.05). Senior-level residents scored higher on posttest analysis, but this result was not significant (R1-R2, 14.70; R3-R5, 15.81; t((24)) = -1.63; p > 0.05). DISCUSSION: There is a deficiency of knowledge of surgical staplers in general surgery residents, more so in junior residents. Didactic instruction is effective in raising the level of knowledge of surgical staplers in all residents, up to a similar level. Surgical educators should consider implementing programs like these for staplers and other types of surgical equipment.

[Anastomotic stenoses correlated with the use of mechanical staplers in the surgery of esophageal cancer]. / Le stenosi anastomotiche correlate all'uso delle suturatrici meccaniche nella chirurgia del cancro dell'esofago.

From 1990 to 1995, 187 patients underwent esophagectomy and esophagogastrostomy with the anastomosis performed inside the chest using a circular stapler. Twenty-three patients (12.3%) developed an anastomotic stricture. The incidence of anastomotic stricture was inversely related to the diameter of the stapler. Also concomitant cardiovascular diseases, morpho-functional disorders of the tubulized stomach (possible related to duodeno-gastric reflux) and neoadjuvant chemotherapy were recognized as significant risks factors. Endoscopic dilations were safe and effective in the treatment of anastomotic strictures.

[The use of an automatic stapler in abdominal hysterectomies. Our experience]. / L'uso della suturatrice automatica nelle isterectomie addominali. Nostra esperienza.

One hundred and four patients were randomized into two groups: group 1 (n = 56) included patients in whom used absorbable staples in vaginal cuff closure; group 2 (n = 48) included patients with classical abdominal hysterectomy. Operating time, facility and outcome 6 months later, were evaluated. Greater costs of absorbable staples compared with sutures can readily be counterbalanced by saving allowed by shorter operating time, no peritoneal contamination, minimal tissue trauma and better cuff healing.

Is it worth using mechanical sutures in gastric surgery?

The use of stapler devices in gastrointestinal surgery has to be justified by the results. Since the cost of staplers is very high, their use should be followed by some advantage in the operating time, the morbidity or mortality rate or the postoperative stay. We have found a slight shortening in the operating time, but only statistically significant for Billroth I, and in the postoperative stay only for oesophagojejunostomies mechanically performed. We have not found any advantage with the other techniques and in the other parameters. Consequently, the use of staplers in gastric surgery should be carefully assessed by the surgeon for each patient in particular, and only used in those cases where a real benefit will be presumed.

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.