Prospective, randomized trial of the biofragmentable anastomosis ring. The BAR Investigational Group

A randomized trial was undertaken to compare the biofragmental anastomotic ring (BAR) with conventional intraperitoneal colorectal anastomotic techniques. Patients were randomized into one of two schemes: BAR versus sutured or BAR versus stapled anastomosis. There were 782 patients entered into the study and 283 patients (36%) had a sutured anastomosis, 104 patients (13%) had a stapled anastomosis, and 395 (51%) had the BAR. Comparison of the BAR with combined suture and stapled controls revealed no significant differences in wound complication, abscess rate, bleeding, anastomotic leaks, ileus, obstruction, or deaths. There were no differences in return of bowel function, return to normal diet, or hospital stay. Intraoperative difficulties occurred in 46 BAR patients (17%), and this was significantly higher (p less than 0.001) than for sutured (3%) but not for stapled anastomoses (11%). The occurrence of these problems did not adversely effect the outcome. The data suggest that the BAR is a safe, satisfactory alternative to sutured or stapled colorectal anastomoses.     

A 10-year single-institutional study of the biofragmentable anastomosis ring

BACKGROUND: The biofragmentable anastomosis ring (BAR) was introduced by Hardy in 1985 as a simple alternative to sutured or stapled intestinal anastomosis. METHODS: The aim of this study was to analyze complications related to the use of the BAR in elective intraperitoneal intestinal anastomosis to identify technical aspects important in the safe use of the device. The BAR was used by a single surgeon over a 10-year period. Three hundred fifty sequential intraperitoneal anastomoses were performed in 346 patients. There were 12 enteroenteric, 2 gastrojejunal, 199 enterocolic, and 137 colocolic anastomoses. RESULTS: There was 1 suture line recurrent carcinoma but no strictures. There were 11 complications that appeared related to construction of the anastomosis, 2 of them resulting in death. The 2 patients who died both had cirrhosis with ascites. Eight patients required re-exploration for suspected anastomotic complications. Six of them recovered and were discharged. CONCLUSION: The BAR appears to be a safe alternative to sutured or stapled bowel anastomosis provided certain precautions are taken in its use.     

Prospective controlled study of gastrointestinal stapled anastomoses

A controlled prospective study was carried out in a university-affiliated community hospital to evaluate the use of gastrointestinal staples compared with conventional sutures for anastomotic construction. The study included 100 randomized cases (50 sutured and 50 stapled) requiring anastomoses. Consecutive patients were accepted into the study, and no patients were excluded. There was no significant difference between the two groups in operating room time or the duration of postoperative hospitalization, nasogastric intubation or intravenous intubation. The complication rate was similar and comparable to previously published results. On three occasions, it was necessary during operation to convert from the use of staples to sutures when immediate disruption was noted at a gastroduodenal anastomosis.     

The incidence of wound infection after stapled or sutured bowel anastomosis and stapled or sutured skin closure in humans and guinea pigs

In a study of antimicrobial prophylaxis in colorectal surgery, a higher incidence of wound sepsis was noted in patients who underwent stapled rather than sutured anastomoses and skin closures. There were six wound infections in 69 patients (8.7%) who underwent nonstapled anastomoses compared with seven in 28 (25%) in whom GIA or EEA staplers were used (p = 0.003). Excluding the EEA-stapled cases, the infection rate was 29% (p = 0.022). In patients who underwent sutured anastomoses, there were no wound infections in 21 whose skin was closed with sutures compared with five in 38 patients (13%) with stapled skin closure (p = 0.082). In an experimental guinea pig model dual incisions were infected with Bacteroides fragilis and Escherichia coli. One incision was then closed with staples, the other with sutures. There was a statistically significant (p = 0.016) advantage to the use of staplers. The possible significance of these results is discussed.     

Comparative surgical and colonoscopic appearance of colon anastomoses constructed with sutures,staples, and the biofragmentable anastomotic ring

Summary The following animal study was undertaken to compare and assess the endoscopic gross appearance and histology of colonic anastomoses constructed with sutures, staples, and the biofragmentable anastomotic ring (BAR).Methods: Three anastomoses—1 BAR, 1 stapled, and 1 sutured—were placed in each of 48 dogs and colonoscopy and anastomotic evaluation were done.Results: No leaks were found by air insufflation at surgery. Grossly, the BAR had serosal hematomas in 27/48 anatomoses vs 7/48 for stapled and 1/48 for sutured (BAR vs stapledP<0.0005 and sutured vs stapledP=0.07). Adhesions were significantly greater for BAR (35/36) and sutured (34/36) compared to stapled (26/36) (BAR vs stapledP=0.01 and sutured vs. stapledP=0.04). Colonoscopic exams at days 3, 7, and 28 showed no significant difference among groups with respect to bleeding, ulceration, necrosis, granulation, or contour. Sutured anastomoses were more stenotic (24/31) than stapled (4/31) or BAR (3/31) ones (BAR vs sutured and sutured vs stapledP<0.005). At 28 days, 10/10 sutured vs 2/10 stapled vs 3/10 BAR were stenotic (BAR vs suturedP=0.02, sutured vs stapledP=0.01). Inflammation on histologic exam at 28 days was not significantly different: sutured (12/12), stapled (12/12), or BAR (9/12). Fibrosis was more prominent in sutured (12/12) than in stapled (5/12) or BAR (4/12) anastomoses (BAR vs suturedP=0.001, sutured vs stapledP=0.004, and BAR vs stapledP=1.00). All anastomoses healed primarily without necrosis or obstruction.Conclusions: (1) Colonoscopy to evaluate anastomoses can be done safely even in the early postoperative period. (2) The BAR anastomoses had the most serosal hematomas; BAR and sutured had more adhesions than stapled anastomoses; and sutured anastomoses had the most stenosis and fibrosis. None of these differences was of clinical significance.     

Comparison of stapling and hand-suture for left-sided large bowel anastomosis

One hundred patients undergoing elective left-sided colonic or rectal resections were randomly allocated to have an anastomosis performed either with the EEA stapling gun or by hand suture using a single layer of interrupted sutures. In six patients the anastomosis could not be performed with the stapling gun. Clinical leakage occurred in two of the remaining 94 cases; both had hand-sutured anastomoses. Radiological leakage was demonstrated in 13 further cases (7 stapled, 6 sutured); there was no statistical difference in leakage rate with stapled and hand-sutured anastomoses.     

Ileocolonic anastomosis: a comparison of the patency of stapled versus hand-sewn techniques.

This study compared strength of hand-sewn sutures to that of staples for end-to-end anastomoses of ileocolostomies in 20 mongrel dogs. In ten dogs, the authors used four applications of staples for the anastomoses. In the other ten, they performed single-layer anastomoses using 4-0 polypropylene sutures. Half the dogs were sacrificed on the third postoperative day; half were sacrificed on the fifth postoperative day. Bursting strengths were obtained by infusing air through a catheter inserted into the colon. Results showed the single-layer hand-sewn anastomosis was significantly stronger than the stapled anastomosis. In addition, a histologic comparison of the two closures showed no difference in inflammatory responses.     

Sutureless anastomosis using a biofragmentable anastomosis ring

The biofragmentable anastomosis ring (BAR) is composed of polyglycolic acid and barium sulfate. When used for intestinal anastomosis, the BAR fragments after the anastomosis is established. We used this device in 43 patients. In three patients, the anastomosis with BAR was abandoned due to technical difficulties. A total of 43 anastomoses with BAR were performed in 40 patients. The operations in which BAR was used included right hemicolectomy in 12 patients, transverse colectomy in 7, sigmoidectomy in 11, small bowel resection in 5 and other bowel resections in 8. The time spent for the BAR anastomsis ranged from 7 to 30 min with a mean of 15.2 min, which was significantly shorter than that of conventional hand-sutured anastomosis in 23 cases. The fragmentation and excretion of the BAR occurred from 14 to 49 days later with a mean of 21.8 days. There was only one instance of anastomotic leakage (1/40, 2.5%), which occurred in a patient with a cytomegaloviral infection of the intestine. A postoperative barium enema study in 28 patients showed no passage disturbance through the anastomosis. In conclusion, the anastomosis using BAR is considered to be a simple, safe, and fast method for performing either colonic or small intestinal anastomosis.     

Cutaneous closure after cardiac operations: a controlled, randomized, prospective comparison of intradermal versus staple closures.

OBJECTIVE: To determine the difference in wound complication and infection rates between suture and staple closure techniques applied to clean incisions in coronary bypass patients. BACKGROUND: The true incidence of postoperative wound complications, and their correlation with closure techniques, has been obscured by study designs incorporating small numbers, retrospective short follow-up, uncontrolled host factors, and narrowly defined complications. METHODS: Sternal and leg wounds were studied prospectively, each patient serving as his or her own control. Two hundred forty-two patients with sternal and saphenous vein harvest wounds had half of each wound closed with staples and the other half with intradermal sutures (484 sternal and 516 leg segments). Wound complications were defined as drainage, erythema, separation, necrosis, seroma, or infection. Infections were identified in the subset having purulent drainage, antibiotic therapy, or debridement. Wounds were examined at discharge, at 1 week after discharge, and at 3 to 4 weeks after operation. Patient preferences for closure type were assessed 3 to 4 weeks after operation. RESULTS: Neither leg nor sternal wounds had a statistically significant difference in infection rate according to closure method (leg sutured = 9.3% vs. leg stapled = 8.9%; p = 0.99, and sternal sutured = 0.4% vs. sternal stapled = 2.5%; p = 0.128). There was, however, a greater complication rate in stapled segments (leg stapled = 46.9% vs. leg sutured = 32.6%; p = 0.001, and sternal stapled = 14.9% vs. sternal sutured = 3.7%; p = 0.00005). Sutures were favored over staples among patients who expressed a preference (sternal = 75.6%, leg = 74.6%). CONCLUSIONS: With the host factors controlled by pairing staples and sutures in each patient, we demonstrated a similar incidence of infection but a significantly lower incidence of total wound complications with intradermal suture closure than with staple closure.     

Sutureless small bowel anastomoses: experimental study in pigs.

OBJECTIVE: To evaluate a new technique for experimental anastomosis with fibrin glue, and to compare the results with those of stapled and one-layer sutured anastomosis. DESIGN: Open laboratory study. SETTING: Teaching hospital, Sweden. ANIMALS: Ten Swedish domestic pigs. INTERVENTIONS: Each pig had three anastomoses made in the small bowel, one by each technique. The pigs were killed on the 4th postoperative day. MAIN OUTCOME MEASURES: Blood flow, collagen concentration, anastomotic index, breaking strength, thickness of bowel wall, and histological appearance. RESULTS: Two pigs died postoperatively, leaving 8 for analysis. The blood flow at each anastomotic site studied by the microsphere technique was similar irrespective of the type of anastomosis (p = 0.3), as was anastomotic collagen concentration (p = 0.09). The anastomotic index, however, was significantly higher in the stapled than in the glued or sutured ones (p = 0.03). The glued anastomosis was the weakest, being only one fifth the strength of the stapled and one third the strength of the sutured anastomosis. There was no sign of rejection of the glue (of human origin) on histological examination. Glued and stapled anastomoses showed signs of mild inflammation, which did not reach the intensity of that around the sutured anastomoses. CONCLUSION: It is possible to make a sutureless anastomosis that does not leak with a modified stapler using fibrin glue instead of staples, but the anastomosis has considerably lower breaking strength than either stapled or sutured anastomoses.     

Stapled esophagogastric anastomosis

In a consecutive, nonrandomized series of 92 patients, esophagogastric anastomosis was performed with a suture technique in 32 patients and with a stapler in 60 patients. Only one anastomotic leak occurred in each group. Stricture later formed in three sutured anastomoses and in eight of the stapled anastomoses. A review of published reports shows anastomotic leak in 3.5 percent of the patients with stapled anastomoses. In patients with sutured anastomoses, leak occurred in approximately 10 percent. The improved results with the stapler do not alter the necessity for meticulous attention to technical detail.     

Stapler suture or single button suture? A controlled clinical study on the comparison of both skin closure methods

In a controlled randomized clinical trial, skin closure with a skin-stapling technique was compared with interrupted sutures on 50 patients (26 sutured and 24 stapled). The two groups were similar in all important respects. The clinical side of the study was to compare 1) the cosmetic results, 2) the time taken to close the skin, and 3) advantages and disadvantages of the two techniques by a questionnaire completed by the clinical staff. The study suggested a cosmetic advantage for the stapling when the results at 6th postop. week were compared. The only significant difference was in cross hatching (22 out of 26 sutured wounds but none of the 24 stapled) which was predominantly visible in sutured wounds. A clear difference was found in operating time. Skin closure with interrupted sutures took 310s, compared with 122s for stapling (alpha = 0,001). Similarly time required to remove the closure material was less with the staples than with sutures. Staples are more expensive than sutures. However the advantage of the staples over the suture in avoiding cross hatching is significant as well as time saving.     

The Stapled Gastrointestinal Tract Anastomosis: Incidence of Postoperative Complications Compared with the Sutured Anastomosis

Performance of gastrointestinal anastomosis by means of surgical stapling devices has achieved popularity in the last decade even though no detailed study has been reported comparing complications following the stapled anastomosis with those following hand sutured procedures performed by the same surgeons. We have reviewed 812 operative procedures on the gastrointestinal tract performed in one hospital over a four year period. Stapled anastomoses were performed in 472 with 13 (2.8%) complications related to the anastomosis; in 296 sutured anastomoses there were nine (3.0%) related complications. Comparison did not disclose any significant difference in the number of complications in these two groups. In 44 instances wherein the anastomosis contained both staples and sutures, there were no related complications. Further analysis of the patients in each group disclosed that stapling procedures were utilized in a much higher percentage of those operations which were performed under emergency conditions or in the presence of intra-abdominal sepsis, intestinal obstruction, and carcinomatosis. If the technical details of surgical stapling are mastered, this technique appears to be as safe as suturing in the performance of anastomoses in the gastrointestinal tract.     

Experience with the EEA stapler for esophagojejunostomy

From January 1979 through December 1986, 239 patients underwent total gastrectomy for gastric cancer. In 94 patients esophagojejunostomy was performed with the EEA stapler and in 145 patients hand sutures were employed. Operating time (mean +/- SD) was 288 +/- 60 minutes in the stapled group and 306 +/- 75 minutes in the sutured group (p less than 0.05). The length of the resected esophagus (mean +/- SD) was 19 +/- 17 mm in the former and 14 +/- 14 mm in the latter (p less than 0.01). The rate of leakage was 7.4% in the former and 13.8% in the latter with no significant difference. Five patients (3.4%) died within 30 days after sutured anastomosis and in two of them death was caused by anastomotic leakage. There was no operative death in the stapled group. It seemed that the stapler was able to simplify and facilitate esophagojejunostomy after total gastrectomy and that anastomosis with the stapler was at least as reliable as that with hand sutures.     

A new technique for sutureless intestinal anastomosis. A prospective, randomized, clinical trial

A polyglycolic acid device has been designed for the performance of sutureless colonic anastomoses. The use of this biofragmentable anastomosis ring (BAR) was compared with conventional techniques in a prospective, randomized study of 59 patients (x age, 49 years) undergoing ileocolostomy (n = 23) or colocolostomy (n = 36). The anastomotic technique was determined at surgery by randomization (BAR, 27 patients; suture, 16 patients; staple, 16 patients). Performance of an anastomosis with the BAR required an average of 22 minutes, a stapled anastomosis required 33 minutes, and the suture technique required 37 minutes. Learning curve error contributed to the six intraoperative complications that occurred with performance of the anastomosis (BAR, three; end-to-end anastomosis [EEA] instrument, three). The two postoperative deaths were unrelated to the anastomosis. Length of hospitalization in uncomplicated patients was the same among the three groups. The 17 patients with prolonged hospitalization had complications unrelated to anastomotic technique. All patients were followed for a minimum of 6 weeks; no additional complications were identified. We concluded that 1) the BAR is a rapid, safe method for performance of sutureless anastomoses; 2) perioperative mortality and morbidity rates of the BAR are comparable to conventional techniques of suture and staple; and 3) long-term follow-up of BAR patients is warranted to determine the incidence of complications, such as structure and/or stenosis.     

Use of disposable skin staplers for bowel anastomosis to reduce laparotomy time in war.

Laparotomy for penetrating wounds to the abdomen is demanding in terms of time, skill and resources. Any modification of existing techniques that will lessen these demands will be of benefit at surgery in forward areas in war. A previous paper (1) compared a method of small bowel anastomosis using disposable skin staplers with a two-layer handsewn anastomosis using fresh pig ileum. The stapled method was both significantly faster to perform and mechanically superior. In two further studies on a total of 12 pigs the stapled method has been compared with a single-layer and a double-layer handsewn small bowel anastomosis. All 12 pigs recovered from laparotomy without complication. Construction times were recorded. The quality of healing of the anastomoses was assessed by clinical observation, post-mortem and histological examination, and tensiometry. The skill required to perform the stapled anastomoses was estimated subjectively. The stapled technique was consistently faster than the handsewn methods. A Kolmogorov two-sample test showed an improvement in times when comparing the stapled method with the single layer, with a significance of P = 0.05. An improvement was also seen when the stapled method was compared with the double layer, with a significance of P = 0.01. There was no statistically significant difference between the construction times for the two handsewn methods. There was no evidence of anastomotic failure or haematoma at post-mortem and no adverse reaction to the metal staples. No features were identified on histology to indicate impaired healing with the stapled method. Tensiometry of the anastomoses showed that the stapled anastomosis is as mechanically reliable as the handsewn anastomosis.(ABSTRACT TRUNCATED AT 250 WORDS)     

Sutures, staplers, leaks and strictures. A review of anastomoses in oesophageal resection at Royal Victoria Hospital, Belfast 1977-1986

Leakage from an oesophagogastric anastomosis has a high morbidity and mortality. Recent evidence suggests that mechanical tissue stapling devices can decrease the rate of anastomotic breakdown but at the expense of an increase in the occurrence of fibrotic strictures at the anastomosis site. This study examines the rate of leakage and stricture in hand sutured and stapled anastomoses. A retrospective study was made of 221 oesophagogastric anastomoses following resection for carcinoma between 1977 and 1986. There were 122 sutured and 99 stapled anastomoses. Leak occurred in 21 sutured (17.2%) and 7 stapled (7.1%), P less than 0.05. If the stapled anastomosis was completely satisfactory and required no reinforcing sutures, the breakdown rate was in fact only 3% (2/69), P less than 0.01. A stapled anastomosis which required reinforcement had a similar chance of breakdown as a sutured anastomosis (16.7%). There was little difference in the performance of registrars in training and consultants at hand-sewn anastomoses with leakage rates of 13.7% and 18%, respectively; P greater than 0.05. The registrars, however, did not improve with the use of the stapler with a leakage rate of 14.3% compared to the consultants' rate of 1.75%, P less than 0.05. Involvement of the limits of resection with tumour slightly favoured breakdown--15.5% compared to 11.6% if the limits were free from tumour, P greater than 0.05. The incidence of malignant strictures was similar in both groups but benign stricture was more common in the stapled group--13% (13/99) compared to 1.6% (2/122), P less than 0.01. The mechanical stapler brings uniformity to the anastomosis but cannot compensate for deficiencies in surgical technique.     

Eliminating the cervical esophagogastric anastomotic leak with a side-to-side stapled anastomosis

BACKGROUND: Although the acute postoperative complications of a cervical esophagogastric anastomosis are less than those with an intrathoracic esophageal anastomosis, the long-term sequelae of a cervical anastomotic leak are not as minor as initially reported. Nearly 50% of cervical anastomotic leaks result in an anastomotic stricture, and the subsequent need for chronic dilatations negates the merits of an operation intended to restore comfortable swallowing. OBJECTIVE: This study was undertaken to determine whether construction of a side-to-side stapled cervical esophagogastric anastomosis after transhiatal esophagectomy could reliably eliminate the majority of anastomotic leaks. METHODS: In 114 consecutive patients undergoing transhiatal esophagectomy, a functional side-to-side cervical esophagogastric anastomosis was constructed with the Auto Suture Endo-GIA II stapler (United States Surgical Corporation, Auto Suture Company Division, Norwalk, Conn) applied directly through the cervical wound. This side-to-side stapled anastomosis has 3 rows of staples. Early postoperative anastomotic morbidity, subsequent need for anastomotic dilatations, and patient satisfaction with swallowing were evaluated. RESULTS: Before the side-to-side stapled anastomosis, the incidence of cervical esophagogastric anastomosis leak in over 1000 patients undergoing transhiatal esophagectomy having a manually sewn anastomosis varied from 10% to 15%. Among the 111 survivors of transhiatal esophagectomy and a side-to-side stapled anastomosis, there were 3 (2.7%) clinically significant anastomotic leaks. This lowered incidence of leaks has contributed to reduction in the average length of stay after an uncomplicated transhiatal esophagectomy to 7 days and has provided more comfortable swallowing, ease of subsequent esophageal dilatations, and greater patient satisfaction. CONCLUSIONS: Construction of the cervical esophagogastric anastomosis with a side-to-side stapled anastomosis greatly reduces the frequency of anastomotic leaks and later strictures. The side-to-side stapled anastomosis is a major technical advance in the progression of refinements of transhiatal esophagectomy and a cervical esophagogastric anastomosis.     

Choledochoduodenostomy: simple side-to-side anastomosis

Choledochoduodenostomy, using a simple side-to-side anastomosis technique, was performed in a 74 year-old woman with common bile duct stones. She had chronic heart failure and chronic obstructive lung disease. The choledochoduodenostomy was performed with a cholecystectomy. A 2-cm-longitudinal incision was made in the common bile duct, and an adjacent longitudinal incision was made in the first portion of the duodenum. The first sutures to be placed were the two corner sutures of the posterior anastomotic wall. Then the two sides were sutured, one from the hepatic side corner of the common duct to the anal side corner of the duodenum, and the other from the duodenal side corner of the common duct to the oral side corner of the duodenum. This anastomosis was performed with one layer of interrupted 4-0 adsorbable sutures. The anterior wall of the anastomosis was constructed in a similar manner. The patient recovered uneventfully, and had no complaints of abdominal pain or fever. This procedure, our original method, is techni-cally simple and safe, and results in minimal tension of the anastomosis. Received: February 19, 1999 / Accepted: May 1, 2000     

Colonic anastomosis using the biofragmentable anastomotic ring and manual suture: a prospective, randomized study.

One hundred and fifty consecutive patients undergoing colonic surgery were randomized into two groups: 71 underwent hand-suture with a two-layer anastomosis of resorbable suture material (3/0 Dexon) and 79 were fitted with the biofragmentable anastomotic ring (Valtrac-BAR). Five patients, two treated using the BAR and three by suturing, developed anastomotic leakage which required a Hartmann-type reoperation. This was successful in four; one patient in the suture group died after reoperation. One patient who underwent suture had an early anastomotic stricture with fatal sequelae. Three other patients (one in the BAR group and two in the suture group) died after operation from other causes. Thus the mortality rate was 6 per cent in the suture group and 1 per cent in the BAR group. During follow-up, one patient in each group underwent reoperation for anastomotic stricture. Recovery of the gastrointestinal tract was similar in the two groups regarding duration of nasogastric drainage, intravenous fluid therapy and ileus. There was no difference between the groups in duration of hospital stay. The BAR seems to be a safe and reliable alternative to conventional suture anastomosis in colonic surgery.