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Description and application of instrumented staples for measuring in vivo bone strain.

In vivo bone strain measurements using strain gages cemented to bony surfaces with cyanoacrylate polymers are limited in duration due to debonding of the gages from bone. As an alternative to the bone bonded strain gages, a technique was developed in which strain gages were first bonded to miniature staples and then the staples embedded into bone. The instrumented staples may be calibrated so that staple strain is directly proportional to bone strain. The method was first validated by comparing the staple output with cemented surface strain gages. Comparison of instrumented staples to cemented strain gages revealed only a 3% deviation from linearity during longitudinal bending; the staples were insensitive to transverse loading. The instrumented staples were then applied to the in vitro canine lumbar spine to determine L2-3 facet loads. Load testing, repeatibility of facet calibration, and validity testing of the in vitro instrumented staples were found to be comparable to that of the previous cemented strain gage techniques. In vivo facet joint application of the instrumented staples for periods of greater than 5 weeks gave load measurements comparable to our previous short-term in vivo studies obtained with cemented strain gages. The advantages of the instrumented staples are a more secure bonding to the bone, and less traumatic surgery for fixation.

Animals↗

Retroperitoneal nonresective staple exclusion of abdominal aortic aneurysms: clinical outcome and fate of the excluded abdominal aortic aneurysms.

PURPOSE: The purpose of this article was to prospectively study analyses outcome after staple exclusion of abdominal aneurysms with specific follow-up of the excluded aneurysm. Whether these data may predict behavior of aneurysms excluded from the circulation by transluminal grafting procedures is also addressed. METHODS: Staple exclusion of abdominal aneurysms with bypass via retroperitoneal incisions was performed in 100 consecutive patients undergoing elective procedures. Risk factors, clamp time, operative time, transfusions, length of stay, complications, platelets, fibrinogen, and fibrin split products were documented. Duplex imaging was performed quarterly for 1 year after exclusion and at least annually thereafter. Serial measurements of aneurysm size and evaluation for thrombosis was obtained. RESULTS: Aneurysm size averaged 5.5 cm. Risk factors included history of smoking (54%), history of heart disease (51%), hypertension (41%), hyperlipidemia (34%), and chronic obstructive pulmonary disease (25%). Clamp time averaged 51 minutes. Forty-eight required no intraoperative transfusion, and 19 needed only autologous blood; the average 24-hour transfusion was 313 cc. Length of stay averaged 11 days, with a median of 8 days, and correlated with age, aneurysm size, and risk factors. The 30-day mortality rate was 4%. Death was associated with longer operative and anesthesia times and with age and risk factors. As calculated by life-table analysis to 5 years, 96.8% of aneurysms thrombosed. No aneurysm expanded, became symptomatic, nor ruptured. Perioperative platelet, fibrinogen, and fibrin split product assays show no evidence of disseminated intravascular coagulation or consumptive coagulopathy. CONCLUSIONS: Staple exclusion and bypass of abdominal aneurysms as described in this study is safe and effective. There has been neither aneurysm expansion nor rupture, and the technique reliably leads to thrombosis of aneurysms without coagulopathy.

Aged↗

Long-term results of endoscopic stapling diverticulotomy for pharyngeal pouches.

OBJECTIVE: The aim of the present study was to evaluate the long-term success of endoscopic stapling as a primary procedure for the treatment of pharyngeal pouches. METHODS: This study is a retrospective case review of 25 patients with pharyngeal pouches treated by endoscopic stapling (23 stapled, 2 abandoned) over a 4-year period (1994 to 1998) at a University teaching hospital in the United Kingdom. Outcome measures used were relief of symptoms over a long-term follow-up of 2 to 5 years. RESULTS: Of the 25 patients analyzed, 12 patients (48%) have remained asymptomatic after their initial stapling. Eight patients (32%) were relieved of their symptoms after revision stapling. The overall long-term success rate for endoscopic stapling was 80% (20 of 25 patients) CONCLUSION: Reduced morbidity and few complications in the elderly make endoscopic stapling a favored primary technique of treating pharyngeal pouches. Open surgery is recommended only in healthy patients with very large pouches.

Aged↗

Fusionless scoliosis correction using a shape memory alloy staple in the anterior thoracic spine of the immature goat.

STUDY DESIGN: Experimental scoliosis was created in goats and then treated using anterior thoracic stapling. OBJECTIVE: To correct, without fusion, a progressive idiopathic-type scoliotic deformity in an immature goat model using a shape memory alloy staple. SUMMARY OF BACKGROUND DATA: Fusionless scoliosis treatment techniques, using minimally invasive approaches to the anterior thoracic spine, provide theoretical advantages over currently available forms of treatment. METHODS: Experimental scoliosis was created in 40 goats using a posterior asymmetric tether with convex rib resection and concave rib tethering for a period of up to 15 weeks. Twenty-seven goats with progressive deformities were used for subsequent study and randomized into 4 treatment groups: group I, anterior thoracic stapling with removal of the posterior tether; group II, removal of the posterior tether only; group III, anterior thoracic stapling with persistent posterior tethering; and group IV, persistent posterior tethering with no treatment. The treatment period lasted an additional 6 to 14 weeks. Staple backout was graded radiographically. After killing the goats, histology and disc biochemistry analyses were conducted. RESULTS: The goats in group I corrected from an initial 57 degrees of curvature to 43 degrees over the duration of the treatment period. Group II goats, which served as a control for group I, corrected from 67 degrees to 60 degrees during the treatment period. Group III goats demonstrated a modest correction from 65 degrees to 63 degrees with the stapling procedure, whereas group IV goats (controls for group III) progressed from 55 degrees to 67 degrees with a persistent posterior tether during the treatment period. The difference between the correction in group III and progression in group IV was statistically significant (P = 0.002). Complications were limited to partial staple backout in 27% of 56 staples. CONCLUSIONS: The results of this study support the efficacy of an anterior thoracic staple in correcting moderately severe scoliosis and halting the progression of more malignant scoliosis without fusion in a goat model.

Alloys↗

The "inadequate doughnut" technique for stapling in rigid rectums.

PURPOSE: A technique to achieve sound anastomosis of a stiff irradiated rectum is described. METHOD: After application of the pursestring, manipulation of the rectal stump creates an inadequate doughnut anteriorly after firing the circular stapler, which is conveniently repaired manually. RESULTS: A sound anastomosis is achieved. CONCLUSION: This technique is efficient and reliable for creating a sound anastomosis in the rigid rectum.

Anastomosis, Surgical↗

Recurrent colonic cancer developing at the site of a stapled stump: report of a case.

We report herein the case of a 54-year-old woman who developed a recurrence of carcinoma in a stapled colon stump 2 years after undergoing an anterior resection for carcinoma of the rectosigmoid colon. At this time an end to end anastomosis (EEA) stapler had been used to perform a side-to-end anastomosis. The implantation of cancer cells was thought to have caused the recurrence.

Anastomosis, Surgical↗

Nonpenetrating stapling: a valuable alternative for coronary anastomoses?

BACKGROUND: The safe development of minimally invasive coronary artery bypass operations might require alternatives to conventional suture-based anastomotic techniques. In this setting, nonpenetrating stapling is an attractive option because of its simplicity of use and potential for improved endothelial preservation. METHODS AND RESULTS: In the experimental part of this study, porcine internal mammary arteries were anastomosed to left anterior descending coronary arteries using either an 8-0 polypropylene running suture or nonpenetrating microclips (7 anastomoses in each group). The endothelium-dependent relaxations to bradykinin of the arterial rings bearing the anastomosis and of noninstrumented rings were compared in organ chamber experiments. There were no significant differences in maximal relaxations (mean +/- SEM) between the microclipped and sutured anastomoses (81%+/-7% versus 74%+/-10%), which were both significantly lower than those of control coronary rings (98%+/-2%, p = 0.001 versus the two anastomosed groups). Histologic examination showed a comparable preservation of the coronary and graft endothelium with both techniques. The clinical part of the study comprised 7 patients in whom the left internal mammary artery was conventionally sutured to the left anterior descending whereas 13 saphenous vein grafts were anastomosed to their target vessels by nonpenetrating staples. There were no clip-related complications. An angiographic assessment of the venous grafts was performed within 10 days postoperatively in all patients. One graft is presumably occluded. The 12 remaining conduits were patent with stapled anastomoses featuring a widely open "shark-mouth" configuration. CONCLUSIONS: These preliminary data suggest that non-penetrating stapling is an easy-to-use technique that competes well with conventional suturing, at least in terms of immediate results. Further studies are warranted to better define its potential place within the armamentarium of minimally invasive coronary artery bypass techniques.

Aged↗

Knee stability after resection of the proximal fibula.

Managing tumors of the proximal fibula may require en bloc resection of the fibular head with the attachment site for the lateral collateral ligament. These resections of the proximal fibula cause unavoidable knee instability. We describe a reconstructive technique intended to minimize that instability. We retrospectively reviewed 24 patients who had proximal fibular resections from 1987 to 2004 and analyzes their knee stability and functional outcome. Resections were less (Type I) or more (Type II) radical depending upon the tumor type. Reconstruction included stapling the lateral collateral ligament to the lateral tibial metaphysis, cast immobilization, and protected weightbearing for 3 weeks. MSTS function scores were available for 19 of the 24 patients. At their most recent followup, 20 patients had a stable knee, three had 1 to 5 mm lateral joint space opening, and one had 6 to 10 mm lateral joint space opening. Patients with Type I resection had a better stability and function than those with a Type II resection. Stapling the lateral collateral ligament was a reliable technique for reconstructing the lateral collateral ligament after resecting the proximal fibula.

Adolescent↗

Effective vascular endostapler techniques in hepatic resection.

The purpose of this report is to describe the technique of liver resection using an endovascular stapling device. A total of 31 patients underwent major hepatic resections with stapling techniques. The authors have used various approaches to portal structures and hepatic veins with the application of a vascular endostapler device. The specific techniques of different hepatectomies are described and illustrated. There were no deaths. A minor complication (biliary fistula) occurred in one patient, related to binary leak from parenchymal transection. No complications directly attributable to stapler ligations of portal pedicle or hepatic veins were observed. Stapling techniques can be helpful in major hepatic resection procedures. The vascular endostapler can significantly reduce both portal vein and hepatic vein closure time and may expedite the transection of the liver, eliminating the risk of slipped ligature following simple ligation.

Hepatectomy↗

Initial experience with the use of fibrin sealant for the fixation of the prosthetic mesh in laparoscopic transabdominal preperitoneal hernia repair.

INTRODUCTION: Laparoscopic inguinal hernia repair offers more rapid recovery and less pain than with the traditional open approach. However, injury to the nerves of the lumbar plexus with subsequent chronic pain or neuralgia has a reported incidence of 2% during laparoscopic hernia repair, particularly when the transabdominal preperitoneal technique (TAPP) is used. These complications are inherent to the use of staples for fixation of the mesh. To avoid nerve irritation, we considered the use of fibrin sealant for the fixation of the mesh instead of staples. The aim of this study was to evaluate this technique and to compare the short-term follow-up of these patients with patients who underwent the staple repair technique. This is the first reported use of fibrin sealant in laparoscopic TAPP hernia repair. METHOD: Between September and November 2004, we performed 17 consecutive laparoscopic hernia repairs (TAPP) in 14 patients (3 bilateral hernias) with primary hernias. The prosthetic mesh was fixed (10 x 15 cm) with 1 ml fibrin. The fibrin was applied using a special laparoscopic applicator. The peritoneum was closed with absorbable sutures. The postoperative course of these patients was compared with a cohort of matched patients who received the traditional staple fixation of the prosthetic mesh. RESULTS: Patients were evaluated at a median follow-up of 10.4 months (3.8-16.0 months). All patients underwent postoperative physical examinations. No recurrent hernia was found. There were 2 seromas and one hematoma in the stapled group. In the stapled group, one patient had pain in the area of the lateral femoral cutaneous nerve. There was no postoperative complication in the non-stapled group. CONCLUSION: Fibrin fixation of the mesh during laparoscopic transabdominal preperitoneal inguinal hernia repair is feasible without higher risk of recurrences. In addition the fibrin fixation method may decrease postoperative neuralgia and reduce the incidence of postoperative seromas and hematomas.

Female↗

Prospective randomized trial comparing bilateral lung volume reduction surgery to pulmonary rehabilitation in severe chronic obstructive pulmonary disease.

Several uncontrolled studies report improvement in lung function, gas exchange, and exercise capacity after bilateral lung volume reduction surgery (LVRS). We recruited 200 patients with severe chronic obstructive pulmonary disease (COPD) for a prospective randomized trial of pulmonary rehabilitation versus bilateral LVRS with stapling resection of 20 to 40% of each lung. Pulmonary function tests, gas exchange, 6-min walk distance, and symptom-limited maximal exercise testing were done in all patients at baseline and after 8 wk of rehabilitation. Patients were then randomized to either 3 additional months of rehabilitation or LVRS. Thirty-seven patients met study criteria and were enrolled into the trial. Eighteen patients were in the medical arm; 15 of 18 patients completed 3 mo of additional pulmonary rehabilitation. Thirty-two patients underwent LVRS (19 in the surgical arm, 13 crossover from the medical arm). After 8 wk of pulmonary rehabilitation, pulmonary function tests remained unchanged compared with baseline data. However, there was a trend toward a higher 6-min walk distance (285 +/- 96 versus 269 +/- 91 m, p = 0.14) and total exercise time on maximal exercise test was significantly longer compared with baseline values (7.4 +/- 2.1 versus 5.8 +/- 1.7 min, p < 0.001). In 15 patients who completed 3 mo of additional rehabilitation, there was a trend to a higher maximal oxygen consumption (V O(2)max) (13.3 +/- 3.0 versus 12.6 +/- 3.3, p < 0.08). In contrast, at 3 mo post-LVRS, FVC (2.79 +/- 0.59 versus 2.36 +/- 0.55 L, p < 0.001) and FEV(1) (0.85 +/- 0.3 versus 0.65 +/- 0.16 L, p < 0.005) increased whereas TLC (6.53 +/- 1.3 versus 7.65 +/- 2.1 L, p < 0.001) and residual volume (RV) (3.7 +/- 1.2 versus 4.9 +/- 1.1 L, p < 0.001) decreased when compared with 8 wk postrehabilitation data. In addition, Pa(CO(2)) decreased significantly 3 mo post-LVRS compared with 8 wk postrehabilitation. Six-minute walk distance (6MWD), total exercise time, and V O(2)max were higher after LVRS but did not reach statistical significance. However, when 13 patients who crossed over from the medical to the surgical arm were included in the analysis, the increases in 6MWD (337 +/- 99 versus 282 +/- 100 m, p < 0.001) and V O(2)max (13.8 +/- 4 versus 12.0 +/- 3 ml/kg/min, p < 0.01) 3 mo post-LVRS were highly significant when compared with postrehabilitation data. The Sickness Impact Profile (SIP), a generalized measure of quality of life (QOL), was significantly improved after 8 wk of rehabilitation and was maintained after 3 mo of additional rehabilitation. A further improvement in QOL was observed 3 mo after LVRS compared with the initial improvement gained after 8 wk of rehabilitation. There were 3 (9.4%) postoperative deaths, and one patient died before surgery (2.7%). We conclude that bilateral LVRS, in addition to pulmonary rehabilitation, improves static lung function, gas exchange, and QOL compared with pulmonary rehabilitation alone. Further studies need to evaluate the risks, benefits, and durability of LVRS over time.

Combined Modality Therapy↗

Stapled versus hand-sewn anastomoses in emergency intestinal surgery: results of a prospective randomized study.

PURPOSE: Sutured and stapled intestinal anastomoses are perceived to be equally safe in elective intestinal surgery. However, our search of the literature failed to find any studies comparing hand-sewn and mechanical anastomoses in emergency intestinal surgery. Thus, we compared the short-term outcomes of patients with sutured as opposed to stapled anastomoses in emergency intestinal surgery. METHODS: Between 1995 and 2001, 201 patients underwent emergency intestinal operations at the Department of Emergency Surgery of Sant'Orsola-Malpighi University Hospital. The outcomes of patients with sutured and stapled anastomoses were compared in a prospective analysis. Patients were randomly divided into a stapled group (106 anastomoses) with anastomoses made using linear and circular staplers, and a hand-sewn group (95 anastomoses) with anastomoses made by double-layer suturing. RESULTS: There were no significant differences between the groups in operative indications or other parameters. The operation times in the stapled group were significantly shorter than those in the hand-sewn group (P < 0.05), but there were no significant differences in anastomotic leak rates, morbidity, or postoperative mortality between the two groups. CONCLUSIONS: In emergency intestinal surgery comparable results can be achieved using mechanical and manual anastomoses.

Aged↗

Cumulative risk of developing polyps or malignancy at the ileal pouch-anal anastomosis in patients with familial adenomatous polyposis.

Restorative proctocolectomy with an ileal pouch-anal anastomosis is performed in an increasing number of patients with familial adenomatous polyposis (FAP). Two techniques are currently used to construct an ileal pouch-anal anastomosis: (1) a double-stapled anastomosis between the pouch and the anal canal and (2) mucosectomy with a hand-sewn ileoanal anastomosis at the dentate line. Although this procedure is thought to abolish the risk of colorectal adenoma, an increasing number of case reports have been published concerning the development of adenoma at the anastomotic site. The purpose of this study was to evaluate the overall cumulative risk of developing adenomatous polyps after ileal pouch-anal anastomosis and to compare the cumulative risk after either anastomotic technique. A total of 126 consecutive FAP patients undergoing a restorative proctocolectomy were identified from polyposis registries in The Netherlands, Denmark, Italy, Germany, and New York. Life-table analysis was used to calculate the cumulative risk of developing polyps in 97 patients with at least 1 year of endoscopic follow-up (median 66 months, range 12 to 188 months). A double-stapled anastomosis was used in 35 patients, whereas in 62 patients a hand-sewn anastomosis with a mucosectomy was performed. In 13 patients polyps developed at the anastomotic site, four with severe and four with moderate dysplasia. None of the patients developed a carcinoma at the anastomotic site. The cumulative risk of developing a polyp at the anastomotic site was 8% (95% confidence interval 2% to 14%) at 3.5 years and 18% (95% confidence interval 8% to 28%) at 7 years, respectively. The risk of developing a polyp at the anastomotic site within 7 years was 31% for patients with a double-stapled vs. 10% for patients with a hand-sewn anastomosis with mucosectomy (P = 0.03 [log-rank test]). Because FAP patients undergoing a restorative proctocolectomy with either a double-stapled or hand-sewn anastomosis have a substantial risk of developing adenomatous polyps at the anastomotic site, lifelong endoscopic surveillance is mandatory in both groups.

Adenoma↗

Urgent proctocolectomy in ulcerative colitis.

UC being a typical medical disease is encountered by the surgeon only in the stage of toxic megacolon or in case of severe complication during conservative treatment such as perforation, haemorrhage, obstruction or malignity. The authors operated urgently 6 young women with all these complications performing total proctocolectomy, constructing ileal pouch with complete stapling technique. In spite of high rate of complications the results are promising. The best prevention of malignant change and complication is the earlier indication for operative treatment which offers the ideal treatment for patients with UC.

Adolescent↗

Treatment of recurrent anterior dislocation of the shoulder by duToit Staple capsulorrhaphy. Results of long-term follow-up study.

DuToit Staple Capsulorrhaphy was performed on 79 patients during a period of ten and one-half years. Sixty-five patients were followed for an average period of nine years (26 months to ten and one-half years). Separation of the glenoid labrum from the glenoid rim was noted in 94% of the cases. A markedly lax and redundant capsule was noted in 6% of the cases. A bucket-handle tear of the glenoid labrum was noted in 4% of the cases. Fracture of the anterior rim of the glenoid was noted in 6% of the cases. There was one recurrence of dislocation (1.78%); 94% were rated as excellent; 4% were rated good; and 2% were rated poor. Out of 70% of the patients who were participating in athletic activities, 58% returned to athletic activities after surgical repair. Stapling the glenoid labrum to the glenoid is an effective method of treatment of recurrent anterior dislocation of the shoulder.

Adolescent↗

Randomized clinical trial of fixation vs nonfixation of mesh in total extraperitoneal inguinal hernioplasty.

HYPOTHESIS: Mesh fixation in the extraperitoneal space during endoscopic total extraperitoneal inguinal hernioplasty might be related to an increase in postoperative pain, morbidity rate, and hospital costs. DESIGN: Randomized clinical trial. SETTING: University teaching hospital. PATIENTS: From January 1999 to December 2001, 170 patients with inguinal hernia were invited to participate; 85 patients were randomized to each group. INTERVENTION: Total extraperitoneal inguinal hernioplasty with or without mesh fixation using staples. MAIN OUTCOME MEASURES: Operating time, morbidity rate, chronic pain, recurrences, and hospital cost were analyzed. Follow-up was considered complete when it included a physical examination at 24 months (mean, 36 +/- 12 months). RESULTS: The statistical study showed no significant differences with regard to epidemiological factors, hernia type, operating time, morbidity, or recurrences when the mesh was stapled, although the total cost of the process was higher (P<.001). CONCLUSIONS: Stapling the mesh in total extraperitoneal inguinal hernioplasty offers no advantages and increases the cost of the process. Our results suggest the possibility of limiting the use of mesh fixation in total extraperitoneal inguinal hernioplasty to cases of direct bilateral hernias.

Costs and Cost Analysis↗

Fibrin sealing versus stapling of hernia meshes in an onlay model in the rat.

Incisional and inguinal hernia repair are among the most common procedures of general surgery. Mesh fixation by means of staples or sutures may lead to severe complications. The use of fibrin sealant (FS) has been suggested as alternative, but data on biocompatibility and adhesive strength of FS in combination with macroporous meshes is limited. Ventral hernia (n = 8 per group) was treated in rats in onlay technique with two types of meshes, fibrin sealed or stapled. TI-Mesh (TMxl) extralight and VYPROII (VPII) were tested 17 days post op. No failure in mechanical tests (tensile and burst strength) occurred in sealed or stapled meshes. Histology revealed equally good tissue integration and neovascularization in all groups. Fibrin sealant yields excellent fixation in experimental hernia repair. This rat model is suitable for testing meshes and fixation techniques.

Animals↗

Stapled coronary anastomosis with minimal intraluminal artifact: The S2 Anastomotic System in the off-pump porcine model.

OBJECTIVE: A reliable, easy-to-use, 1-shot anastomotic device will significantly push the barrier for less invasive coronary bypass surgery. The current study was designed to test the safety, efficacy, and early patency of a novel distal anastomotic device. METHODS: The S2 Anastomotic System (iiTech BV, Amsterdam, The Netherlands) was used in 10 consecutive pigs (73 kg) on a mild antiplatelet regimen. In each animal, the device was used to create an internal thoracic artery to left anterior descending bypass on the beating heart. The anastomoses were evaluated intraoperatively (n = 10), at 2 days (n = 2), and at 5 weeks (n = 8) by functional flow measurements, postmortem angiography, and histomorphologic examination. RESULTS: In all pigs, the S2 Anastomotic System rapidly created successful anastomoses at the first attempt (graft loading and coronary ischemia time: 1.2 +/- 0.3 minutes and 3.0 +/- 0.6 minutes) on target vessels of 1.6 to 2 mm inner diameter. There were no technical failures or anastomotic leaks requiring additional sutures. Both intraoperatively and at the time of death, ischemically induced peak hyperemic flow responses demonstrated widely patent bypasses, which were confirmed by postmortem angiography (FitzGibbon grade A, n = 10) and macroscopic evaluation (anastomotic orifice: 2 mm). Histomorphologic evaluation showed a normal healing response with negligible neointima covering the connector and limited streamlining repair tissue formation between the staple-like elements of the connector. CONCLUSIONS: The S2 Anastomotic System consistently created automated, fast, and reliable internal thoracic to coronary artery anastomoses on the porcine beating heart with excellent graft patency and healing characteristics at the 5-week follow-up.

Anastomosis, Surgical↗