Use Of Surgical Staplers Research Articles

Stapled enterectomy reduces surgical time when compared with sutured enterectomy: a retrospective review of 54 cats.

Feline enterectomy is commonly performed in referral and general veterinary practice; however, existing studies in the veterinary literature lack significant case numbers to guide clinical decision-making. In addition, no studies have evaluated the use of surgical staplers in cats for this procedure. This study aimed to compare the use of surgical staplers for functional end-to-end anastomosis (SFEEA) with hand-sewn end-to-end anastomosis (EEA) in cats. Additional aims included investigating the feasibility of surgical staplers in cats as well as assessing short- and long-term complications and outcomes. The medical records of four referral hospitals were retrospectively searched for cats that had undergone enterectomy between 2003 and 2022. Preoperative, intraoperative and postoperative data were compared between the SFEEA and EEA groups, with a median long-term follow-up time of 488 days (interquartile range 255-1030). In total, 54 cats met the inclusion criteria for this study, with 24 undergoing an SFEEA while 30 underwent EEA. There was a significant difference in surgical time between the two groups. The SFEEA group had a mean surgical time 34.3 ± 9.274 mins faster than the EEA group (P <0.001). Unique complications reported for the SFEEA group included haemo abdomen and anastomotic stricture. SFEEA should be considered in cats where anaesthetic time should be kept as short as possible, such as patients with American Society of Anesthesiologists scores of 3-4. Stricture at the anastomotic site may be seen in the long term for cats undergoing SFEEA.

Mortality related to the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database

BackgroundSurgical staplers and clip appliers are commonly used and have a potential to malfunction, which may result in serious injury or death. These events are self-reported to the Food and Drug Administration and compiled in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. This study characterizes mortality related to surgical stapler and clip applier failure reported in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. MethodsThe Food and Drug Administration’s Manufacturer and User Facility Device Experience database was reviewed between 1992 and 2016 for medical device reports related to surgical staplers and clip appliers filed under the following product codes: GAG, FZP, GDO, GDW, KOG, and GCJ. Adverse events including death and the type of device failure were reviewed. Temporal trends in reported deaths related to device failure were analyzed and the Healthcare Cost and Utilization Project database was used to adjust for annual surgical case volume using linear regression analysis. ResultsA total of 75,415 malfunctions, 21,115 injuries, and 676 deaths were associated with the use of surgical stapler and clip applier devices. Most deaths occurred postoperatively (N = 516, 76.3%) and were due to infection/sepsis (N = 89, 17.2%) or vascular injuries (N = 110, 21.3%). Intraoperative mortality (N = 79, 11.7%) was primarily due to vascular injuries (N = 73, 92.4%). Device failures resulting in death were noted both intraoperatively (N = 268, 39.6%) and postoperatively (N = 325, 48.1%). In post hoc root cause analysis, a surgical stapler and clip applier device problem was the most common attributed cause of death (N = 238, 65.4%). In the linear regression analysis, there was a significant increase in the mortality from device failure in the study period after adjusting for annual surgical volume (P < .01). ConclusionMortality related to the use of surgical staplers and clip appliers is increasing. Most deaths occurred postoperatively, and an increased awareness of potential life-threatening complications is warranted when these devices are used.

MP32-15 MORTALITY RELATED TO THE USE OF STAPLER DEVICES AND CLIP APPLIERS: ANALYSIS OF THE FDA MAUDE DATABASE

You have accessJournal of UrologyCME1 May 2022MP32-15 MORTALITY RELATED TO THE USE OF STAPLER DEVICES AND CLIP APPLIERS: ANALYSIS OF THE FDA MAUDE DATABASE Balaji Reddy, Shirin Razdan, and Sanjay Razdan Balaji ReddyBalaji Reddy More articles by this author , Shirin RazdanShirin Razdan More articles by this author , and Sanjay RazdanSanjay Razdan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002581.15AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Surgical staplers and clip appliers are commonly used. These devices have a potential to malfunction, which may result in serious injury or death. This study characterizes mortality related to surgical stapler and clip applier failure reported in the FDA’s MAUDE database. METHODS: The FDA’s MAUDE database was reviewed between 1992 and 2016 based on the following product codes: GAG, FZP, GDO, GDW, KOG and GCJ. Adverse events including death and the type of device failure were reviewed. Temporal trends in reported deaths related to device failure were analyzed and the Healthcare Cost and Utilization Project database was used to adjust for annual surgical case volume using linear regression analysis. We identified temporal trends in mortality associated with surgical stapler and clip applier malfunction. RESULTS: A total of 75,415 malfunctions, 21,115 injuries, and 676 deaths were associated with the use of surgical stapler and clip applier devices. Most deaths occurred post-operatively (N=516, 76.3%) and were due to infection/sepsis (N=89, 17.2%) or vascular injuries (N= 110, 21.3%). Intra-operative mortality (N=79, 11.69%) was primarily due to vascular injuries (N=73, 92.4%). Device failures resulting in death were recognized both intra-operatively (N=268, 39.6%) and post-operatively (N=325, 48.1%). In post hoc root cause analysis, a surgical stapler and clip applier device problem was the most common attributed cause of death (N=238, 65%). In the linear regression analysis, there was a significant increase in the mortality from device failure in recent years after adjusting for annual surgical volume (p <0.01). CONCLUSIONS: Mortality related to the use of surgical stapler and clip applier is increasing. Most deaths occurred post operatively, and an increased awareness of potential life threatening complications is warranted when these devices are utilized. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e537 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Balaji Reddy More articles by this author Shirin Razdan More articles by this author Sanjay Razdan More articles by this author Expand All Advertisement PDF DownloadLoading ...

A Protocol for Roux-en-Y Gastric Bypass in Rats using Linear Staplers.

Roux-en-Y gastric bypass (RYGB) is commonly performed for the treatment of severe obesity and type 2 diabetes. However, the mechanism of weight loss and metabolic changes are not well understood. Multiple factors are thought to play a role, including reduced caloric intake, decreased nutrient absorption, increased satiety, the release of satiety-promoting hormones, shifts in bile acid metabolism, and alterations in the gut microbiota. The rat RYGB model presents an ideal framework to study these mechanisms. Prior work on mouse models have had high mortality rates, ranging from 17 to 52%, limiting their adoption. Rat models demonstrate more physiologic reserve to surgical stimulus and are technically easier to adopt as they allow for the use of surgical staplers. One challenge with surgical staplers, however, is that they often leave a large gastric pouch which is not representative of RYGB in humans. In this protocol, we present a RYGB protocol in rats that result in a small gastric pouch using surgical staplers. Utilizing two stapler fires which remove the forestomach of the rat, we obtain a smaller gastric pouch similar to that following a typical human RYGB. Surgical stapling also results in better hemostasis than sharp division. Additionally, the forestomach of the rat does not contain any glands and its removal should not alter the physiology of RYGB. Weight loss and metabolic changes in the RYGB cohort were significant compared to the sham cohort, with significantly lower glucose tolerance at 14 weeks. Furthermore, this protocol has an excellent survival of 88.9% after RYGB. The skills described in this protocol can be acquired without previous microsurgical experience. Once mastered, this procedure will provide a reproducible tool for studying the mechanisms and effects of RYGB.

Modification of Turnbull–Cutait transanal colon pull-through as a salvage procedure in cases of failed low colorectal anastomosis

Introduction In 1961, Turnbull and Cutait described the colon pull-through with delayed anastomosis for patients with rectal cancers below peritoneal reflection, Hirschsprung disease, and Chagas disease. With the technological upgrading, the surgical staplers offered an easy and safe primary anastomosis in the bottom of the pelvis and replaced the pull-through. Despite this, the pull-through still has a role nowadays in patients with complex anorectal diseases in whom achieving primary anastomosis is difficult even with the use of surgical staplers. Aim The authors are reporting the experience in Turnbull-Cutait pull-through operation, its indications, the technical modification, and the results. Patients and methods A total of 28 patients had two-stage transanal pull through procedure after completing the original resection for different anorectal problems. In the first stage, the left colon was completely mobilized, pulled through, and fixed to the anal canal, and the perianal skin was done, and covering ileostomy was raised. In the second stage, the pull-through was excised few cm below the anal verge, and the ileostomy was closed. Patients were followed up for 6 months to document the continence status and the development of any complications. Results Autoamputation of the colon stump occurred in 10 patients. Retraction of the pulled colon occurred in five patients causing severe pelvic sepsis in three of them. The three patients were treated by dismantling the anastomosis terminal colostomy. Other minor complications included anal pain and discharge. The patients showed wide range of continence state with clear improvement after 6 months. Conclusion Salvage Turnbull–Cutait pull-through is an easy procedure that can be used in patients with complex anastomotic complications and difficult pelvic anatomy. Retraction and gangrene of the colon stump are serious complications that need to be studied to improve the outcome of this procedure. Continence is definitely reduced, but it is accepted by most patients.

Buttressing Staples with Cholecyst-derived Extracellular Matrix (CEM) Reinforces Staple Lines in an Ex Vivo Peristaltic Inflation Model

Staple line leakage and bleeding are the most common problems associated with the use of surgical staplers for gastrointestinal resection and anastomotic procedures. These complications can be reduced by reinforcing the staple lines with buttressing materials. The current study reports the potential use of cholecyst-derived extracellular matrix (CEM) in non-crosslinked (NCEM) and crosslinked (XCEM) forms, and compares their mechanical performance with clinically available buttress materials [small intestinal submucosa (SIS) and bovine pericardium (BP)] in an ex vivo small intestine model. Three crosslinked CEM variants (XCEM0005, XCEM001, and XCEM0033) with different degree of crosslinking were produced. An ex vivo peristaltic inflation model was established. Porcine small intestine segments were stapled on one end, using buttressed or non-buttressed surgical staplers. The opened, non-stapled ends were connected to a peristaltic pump and pressure transducer and sealed. The staple lines were then exposed to increased intraluminal pressure in a peristaltic manner. Both the leak and burst pressures of the test specimens were recorded. The leak pressures observed for non-crosslinked NCEM (137.8 +/- 22.3 mmHg), crosslinked XCEM0005 (109.1 +/- 14.1 mmHg), XCEM001 (150.1 +/- 16.0 mmHg), XCEM0033 (98.8 +/- 10.5 mmHg) reinforced staple lines were significantly higher when compared to non-buttressed control (28.3 +/- 10.8 mmHg) and SIS (one and four layers) (62.6 +/- 11.8 and 57.6 +/- 12.3 mmHg, respectively) buttressed staple lines. NCEM and XCEM were comparable to that observed for BP buttressed staple lines (138.8 +/- 3.6 mmHg). Only specimens with reinforced staple lines were able to achieve high intraluminal pressures (ruptured at the intestinal mesentery), indicating that buttress reinforcements were able to withstand pressure higher than that of natural tissue (physiological failure). These findings suggest that the use of CEM and XCEM as buttressing materials is associated with reinforced staple lines and increased leak pressures when compared to non-buttressed staple lines. CEM and XCEM were found to perform comparably with clinically available buttress materials in this ex vivo model.

Surgical Stapling Devices in Veterinary Medicine: A Review

To review indications, benefits, and complications of surgical stapling in animals. Literature review. Benefits and complications of surgical stapling depend on the procedure performed. Use of surgical staplers does not improve wound strength but may decrease surgical time. In patients at significant risk for intraoperative contamination or morbidity from prolonged anesthesia time, use of stapling devices should be considered.

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

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. 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. 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. 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.

Endoscopic dilation of colonic postoperative strictures

After the use of surgical staplers had become widespread, the number of colonic postoperative stenoses was observed to have increased. Nevertheless, the clinical relevance of this observation is minimal since only 2-5% of the patients complain of chronic constipation or obstruction symptoms. In such cases medical therapy is somewhat troublesome, and surgical treatment always implies a major operation. Endoscopic dilation has proved to be a reliable, simple, and safe therapeutic alternative. Forty-two patients with evidence of stenosis of either colocolic or colorectal anastomosis underwent mechanical or pneumatic dilation in our unit: 19 patients with a temporary diverting stoma were dilated before the colostomy was removed; in the remaining 23 cases, treatment was given according to the patients' symptoms or because it was not possible to pass the anastomosis with an endoscope. The overall failure rate was 2.4%, and no morbidity or mortality was found. When the percentages of patients successfully treated in one session alone were compared (76.9% versus 51.8%), balloon dilation was found to be more effective than bougienage. In our opinion, endoscopic dilation represents the mainstay of treatment of colonic anastomotic strictures, with surgery being reserved for the rare failures, when recurrence of cancer should be suspected.

Pelvic exenteration: Factors associated with major surgical morbidity

Sixty-nine women underwent pelvic exenteration at Duke University Medical Center from 1970 through 1987. The operative mortality rate was 7.2% with a trend toward a reduction during the course of the study. One or more serious gastrointestinal or genitourinary surgical complication occurred in 26 (38%) patients and 20 (29%) required reoperation for these complications. There was a trend ( P < 0.1) toward an increase in surgical complications among patients who received prior radiation therapy and those requiring urinary diversion, with a decrease among those who underwent gracilis flap pelvic reconstruction. Patients with sigmoid or ileal conduits had a significantly higher incidence of severe surgical complications than those with transverse colon conduits or posterior exenteration alone ( P < 0.05). Those in whom an ileal conduit was constructed without gracilis flap pelvic reconstruction had signficantly more surgical morbidity compared to those who underwent pelvic reconstruction or received a transverse colon conduit ( P < 0.05). Multiple changes in technique since 1978 including (1) the routine use of surgical staplers for bowel resection and anastomosis, (2) the introduction of the transverse colon conduit, and (3) the use of gracilis flap for pelvic reconstruction have combined to produce a significant ( P < 0.05) decrease in life-threatening surgical complications.

Billroth II gastrojejunostomy in dogs. Stapling technique and postoperative complications.

Billroth II gastrojejunostomy was performed with surgical staplers in 6 dogs that were not irradiated and in 11 dogs that subsequently received radiation to the pancreas and proximal part of the duodenum. The dogs were monitored clinically for 135 days and then euthanatized and necropsied. Each gastrojejunostomy site was preserved in formalin and the stomal diameter was measured. No mechanical complications were encountered with the use of surgical staplers and no leakage was observed at the staple closure sites before abdominal closure. All dogs vomited approximately 100 ml of coagulated blood 4 to 8 hours after surgery, and 300 to 400 ml of brown fluid after approximately 24 hours. Vomiting was the most common clinical finding after the first 24 hours. Vomiting was subjectively graded from 1 to 3 with grade 1 representing the least severe problem and grade 3 the most severe. Grade 1 vomiting occurred in 12 of 16 dogs that survived 135 days; in the other four dogs, vomiting was classified as grade 2 or 3. All dogs with grade 1 vomiting had stomal diameters of 1.7 to 2.9 cm (mean, 2.2 +/- 0.4 cm standard deviation). Dogs with grade 2 or 3 vomiting had stomal diameters of 2.2 to 4.0 cm (mean, 3.2 +/- 0.8 cm standard deviation). The difference was statistically significant (p less than 0.005). The percentage of weight gained or lost was recorded for each dog. Two nonirradiated dogs gained body weight, whereas the other nonirradiated dogs and all irradiated dogs lost body weight.(ABSTRACT TRUNCATED AT 250 WORDS)

Use of surgical stapler in adrenal surgery

Use of surgical stapler in adrenal surgery

Operative Surgery: Colon, Rectum, and Anus

By whatever criteria, this book has to be the ultimate as a proctologic operative atlas. It is a veritable colorectal review extravaganza—645 pages, thousands of illustrations by 17 artists from around the world, 62 noteworthy contributors from five countries and almost every continent, and, to top it all off, a price of $199.95. It is a good bet that no matter which operative procedure a surgeon anticipates performing on the large bowel, the technique is well described and illustrated in this volume. Rob and Smith edited the operative surgery series for many years and have now passed the responsibility on to Todd and Fielding. The current volume on colorectal disease makes use of previous editions but adds valuable new chapters on stomas, basic physiology, techniques, operative procedures for creating continent ostomies, a method for dealing with blunt and penetrating trauma, and good sections on the use of surgical staplers. In

Insufficiency quota following the use of surgical staplers in bronchial occlusion

Bei 76 Patienten wurden 80 Bronchien verschiedenster Größenordnung nach Lungenresektion mit dem Klammernaht-Gerät verschlossen. Unter Beachtung einer bestimmten Anwendungstechnik lag die postoperative Frühinsuffizienzquote, auf 80 Bronchien bezogen, bei 5,0 % (4 Patienten).