Biofragmentable Anastomotic Ring Research Articles

Compression versus hand-sewn and stapled anastomosis in colorectal surgery: a systematic review and meta-analysis of randomized controlled trials.

Anastomotic leaks are a feared complication of colorectal resections and novel techniques that have the potential to decrease them are still sought. This study aimed to compare the anastomotic leak rates in patients undergoing compression anastomoses versus hand-sewn or stapled anastomoses. Randomized controlled trials (RCTs) comparing outcomes of compression versus conventional (hand-sewn and stapled) colorectal anastomosis were collected from MEDLINE, Embase and the Cochrane Library. The quality of the RCTs and the potential risk of bias were assessed. Pooled odds ratios (OR) were calculated for categorical outcomes and weighted mean differences for continuous data. Ten RCTs were included, comprising 1969 patients (752 sutured, 225 stapled, and 992 compression anastomoses). Most used the biofragmentable anastomotic ring. There was no significant difference between the two groups in terms of anastomotic leak rates (OR 0.80, 95% confidence interval (CI) 0.47, 1.37; p=0.42), stricture (OR 0.54: 95% CI 0.18, 1.64; p=0.28) or mortality (OR 0.70; 95% CI 0.39, 1.26; p=0.24). Compression anastomosis was associated with an earlier return of bowel function: 1.02 (95% CI 1.37, 0.66) days earlier (p<0.001) and a shorter postoperative stay; 1.13 (95% CI 1.52, 0.74) days shorter (p<0.001), but significant heterogeneity among studies was observed. There was an increased risk of postoperative bowel obstruction in the compression group (OR 1.87; 95% CI 1.07, 3.26; p=0.03). There was no significant difference in wound-related and general complications, or length of surgery. Compression devices do not appear to provide an advantage over conventional techniques in fashioning colorectal anastomoses and are associated with an increased risk of bowel obstruction.

Efficacy and safety of domestic biofragmentable anastomotic ring in the intestinal anastomosis

To investigate the efficacy and safety of the domestic biofragmentable anastomotic ring (BAR) from Hangzhou in the intestinal anastomosis. A total of 134 patients who underwent intestinal anastomosis from February 2010 to April 2011 in the First Municipal People's Hospital of Guangzhou and the First Affiliated Hospital of Zhejiang University were randomized into two groups. The Valtrac BAR from USA was employed in the control group while the experimental group used domestic BAR. The operative performance of the BARs, as well as the patients vital signs and bowel function, complications, fragmentation status of the rings were compared between two groups. No significant difference was found between two groups in the operative performance, the fragmentation status of the BARs, the temperature, blood pressure, heart rate, and bowel function (P>0.05). The domestic BAR possesses similar safety and efficacy with the Valtrac BAR in intestinal anastomosis.

Compression anastomoses in colorectal surgery: a review

The main serious risks of anastomotic construction in the colon and rectum include dehiscence and stricture formation. There is a resurgence of interest in sutureless anastomoses formed by compression elements since the introduction of shape memory alloy (SMA) systems, which evoke minimal early inflammatory response whilst maintaining anastomotic integrity. Currently, the most commonly used SMA is the nickel-titanium (NiTi) alloy that is highly biocompatible, returning to its pre-deformed stable (austenite) shape under different mechanical and thermal loads for use in humans. Pre-clinical data for shape memory alloy systems in colorectal anastomoses are limited, but it appears to be safe in porcine and canine models with limited leakage and reduced stricture formation. There does not appear to be any difference in tissue biochemistry of inflammatory markers when compared with conventional stapled techniques, although the few studies available show a markedly reduced early inflammatory response at the anastomotic site with the NiTi device. The majority of the clinical data concerning compression anastomoses are derived from the biofragmentable anastomotic ring device. This device has fallen out of use because of reported leaks, instrumental failure and problems with device expulsion. A novel SMA device, the NiTi anastomotic ring, permits construction of a low rectal anastomosis construction during open or laparoscopic procedures. The preliminary data demonstrate a safety comparable to conventional staple technology. This device also provides the potential of benefit of reduced anastomotic inflammation, because the compression ring results in direct serosa-to-serosa (or alternatively serosa-to-muscularis propria) apposition without the persistence of residual foreign material. This type of construction could lead to a reduced incidence of early anastomotic leakage and/or the development of anastomotic stenosis. Randomized clinical trials employing a NiTi arm for elective, emergency and high-risk colorectal anastomoses are required to determine its indications and clinical profile as well as to assess whether such technology may selectively obviate the need for proximal diversion in low colorectal anastomoses.

Sutureless jejuno-jejunal anastomosis in gastric cancer patients: a comparison with handsewn procedure in a single institute

BackgroundThe biofragmentable anastomotic ring has been used to this day for various types of anastomosis in the gastrointestinal tract, but it has not yet achieved widespread acceptance among surgeons. The purpose of this retrospective study is to compare surgical outcomes of sutureless with suture method of Roux-and-Y jejunojejunostomy in patients with gastric cancer.MethodsTwo groups of patients were obtained based on anastomosis technique (sutureless group versus hand sewn group): perioperative outcomes were recorded for every patient.ResultsThe mean time spent to complete a sutureless anastomosis was 11±4 min, whereas the time spent to perform hand sewn anastomosis was 23±7 min. Estimated intraoperative blood loss was 178±32ml in the sutureless group and 182±23ml in the suture-method group with no significant differences. No complications were registered related to enteroanastomosis. Intraoperative mortality was none for both groups.ConclusionsThe Biofragmentable Anastomotic Ring offers a safe and time-saving method for the jejuno-jejunal anastomosis in gastric cancer surgery, and for this purpose the ring has been approved as a standard method in our clinic. Nevertheless currently there are few studies on upper gastrointestinal sutureless anastomoses and this could be the reason for the low uptake of this device.

Application of intracolonic bypass procedure in anus-preserving operation for acute obstructive low and middle rectal cancer

Objective To introduce a novel technique of intracolonic shunt procedure used in the anus - preserving operation for acute intestinal obstruction resulted from cancer at low and middle portions of rectum and assess the clinical significance. Methods In total, 81 patients with acute obstruction of low and middle portion of rectum caused by cancer were randomly ( random number) divided into control group and study group. In control group, 42 patients were operated with preventive transverse colonostomy or terminal ileum stoma after low proximal resection of rectum involved in cancer, while 39 patients were operated with intracolonic shunt procedure by using a biodegradable anastomosis ring and a condom placed 5 cm above anastomosis for protection in study group. Results There were no significant differences in sex, age, tumor site, tumor size and the distance from anstomosis to anal-edge between two groups. In both groups, the bowel movement resumed in 2 ~ 5 days after operation (P > 0.05). In study group, the rate of anastomosis leakage was 7.7% (3/39), and leakages were treated with drainage for 7.1 days in average to be healed, and the biodegradable anastomosis ring detached and were discharged in 14 -23 days (17 days in average), and there were no complications of drainage happened. The anastomotic stenosis occurred in three patients (7. 7% ) within 6 months after operation. In control group, 11.9% patients (5/42) had anastomosis leakage and they treated with drainage for 18.2 days in average to get the leakage healed, and 35. 7% patients (15/42) had stoma complications, and anastomotic stenosis happened in 28.6% patients (12/42) within 6 months after operation, and 7. 1% patients need another operation because of severe anastomosis stenosis. There were no significant differences in rate of anastomosis leakage between tow groups ( P > 0. 05), but there were significant differences in drainage days after anstomosis leakage happened and 6 - months anastomosis stenosis between two groups (P<0.05). Conclusions In the anus -preserving operation for acute intestinal obstruction at low and middle portions of rectum caused by cancer , the intracolonic shunt procedure is convenient and safty, and reduces the hazard incurred by anastomosis leakage and anastomosis stenosis compared with classic stoma operation. Key words: Intracolonic bypass; Rectal neoplasm; Acute intestinal obstrution; Biofragmentable anastomotic ring; Condom; Stoma; Anastomotic leakage; Anastomotic stenosis

Clinical study of a new intracolonic drainage to protect low rectal anastomotic leakage

To investigate the value of using protective new intracolonic drainage in decreasing low colorectal anastomotic leakage. One hundred and nineteen cases of rectal cancer accepted low anterior resection were randomly assigned to study group (n=55) and control group (n=64). The study group was added with a new intracolonic drainage composed of biofragmentable anastomosis ring and condom during operation. The control group was added with protective ileostomy during operation. The results of surgery were compared between the two groups. All the cases were followed up over three months and there were no perioperative death. There were no significant differences in physiopathological factors such as age, sex, body type, site of tumor, size of tumor, differentiation of tumor, site of anastomosis, condition of nutrition, concomitant disease between the two groups. In the study group, anastomotic leakage occurred in 4 cases (7.3%), the drainage devices were ablated 18.3 days after operations and there were no drainage-related complications; light anastomotic stenosis occurred in 3 cases (5.5%) three months after operations. Among the cases with leakage, no severe abdominal infection was found, the time of abdominal drainage was 4.8 days, and the amount of abdominal drainage was 12.8 ml/d in primary three days after leakage. In the control group, anastomotic leakage occurred in 7 cases (10.9%), ostomy-related complications occurred in 29 cases (45.3%), anastomotic stenosis occurred in 18 cases (28.1%) and severe anastomotic stenosis occurred in 4 cases (6.3%) after three months. Among the cases with leakage, severe infection occurred in two cases, anastomotic spoiled occurred in one case, the amount of abdominal drainage was 35.4 ml/d in primary three days after leakage, and the time of abdominal drainage was 17.1 days. There was no significant difference in the rate of anastomotic leakage between the two groups (P>0.05). But there were significant differences in the amount of abdominal drainage, the time of abdominal drainage and abdominal infection in the cases of anastomotic leakage (P<0.01). There was significant difference in anastomotic stenosis after three months between the two groups (P<0.01). The intracolonic drainage is a simple, safe and effective method in protecting low colorectal anastomotic leakage, and avoiding harmful results caused by anastomotic leakage. Compared with protective ileostomy, intracolonic drainage can avoid stomy-related physical mental suffering and complications, the rate of later anastomotic stenosis is less, and the time of abdominal drainage is shorter in the cases with leakage.

Clinical application of biofragmentable anastomosis ring for intestinal anastomosis

To compare the efficacy of the biofragmentable anastomotic ring (BAR) with conventional hand-sutured and stapling techniques,and to evaluate the safety and applicability of the BAR in intestinal anastomosis. The totol of 498 patients performed intestinal anastomosis from January 2000 to November 2005 were allocated to BAR group (n=186), hand-sutured group (n=177) and linear cutter group (n=135). The operative time, postoperative convalescence and corresponding complication were recorded. Postoperative anastomotic inflammation and anastomotic stenosis were observed during half or one year follow-up of 436 patients. The operative time was (102 +/- 16) min in the BAR group, (121 +/- 15) min in the hand-sutured group, and (105 +/- 18 ) min in the linear cutter group. The difference was significant statistically (P <0.05). The operative time in BAR group and linear cutter group was shorter than hand-sutured group. One case of anastomotic leakage was noted in the BAR group, one case in the hand-sutured group, and none in the linear cutter group. They were cured by conservative methods. One case of anastomotic obstruction happened in the BAR group, one case in the hand-sutured group. Two of them were cured by conservative methods. Two cases of anastomotic obstruction happened in the hand-sutured group. However, one of them required reoperation to remove the obstruction. In the BAR, hand-sutured and the linear cutter group, the postoperative first flatus time was (67.2+/- 4.6) h, (70.2 +/- 5.8) h and (69.2 +/- 6.2)h, respectively. No significant differences were observed among three groups(P > 0.05). The rate of postoperative anastomotic inflammation was 3.0 % (5/164) in the BAR group, 47.8 % (76/159) in hand-sutured group and 7.1 % (8/113) in the linear cutter group. The difference was significant statistically (P <0.05). The rate of postoperative anastomotic inflammation in the BAR group and in the linear cutter group was less than that in hand-sutured group. BAR is one of rapid,safe and effective methods in intestinal anastomosis. It has less anastomotic inflammatory reaction than hand-sutured technique. It should be considered equal to manual and stapler methods.

Sutureless intestinal anastomoses

Sutureless intestinal anastomoses can be achieved either by compression, where two inverted rings of bowel are compressed by a hollow circular device that subsequently sloughs away and is passed anally, or by the use of tissue glues or laser welding. Compression devices used clinically with success are the Valtrac biofragmentable anastomotic ring, the polypropylene rings described by Rosati and the AKA guns. Glued anastomoses have only been used in animals and seem to be unsafe. However, laser-welded intestinal anastomoses appear highly promising in experimental studies and further development of this technique is warranted.

The Use of the Valtrac Ring in the Upper and Lower Gastrointestinal Tract, for Single, Double, and Triple Anastomoses: A Report of 50 Cases

The Valtrac biofragmentable anastomotic ring (V-BAR) technique has been widely used in clinical practice, particularly in anastomoses of the colon. The success of this method encouraged some surgeons to use it also in anastomosis of the small intestine. We are convinced that the method can be used successfully also in anastomosis of the small intestine and the upper gastrointestinal tract, particularly in cases of technically difficult and high-risk anastomoses. Between 1995 and 1998, we used the V-BAR in 35 patients, performing a total of 50 anastomoses. In 13 patients a double anastomosis was created in the same operation, and in one patient a triple anastomosis was created. In all we performed one end-to-end esophagojejunostomy, one gastrojejunostomy, six gastroileostomies, two duodenojejunal anastomoses, 13 end-to-end duodenoileostomies, one jejuno-jejunal anastomosis, 18 end-to-side ileoileal anastomoses, one ileocolic anastomosis, and seven colocolic anastomoses. Follow-up at between 2 and 36 months showed good overall results with regard to resumption of intestinal transit and canalization, even in those cases in which a double and triple suture was performed using the Valtrac ring. In our experience, the V-BAR can be used in upper gastrointestinal surgery with excellent results. Compared with manual sutures, the ring allows better and faster resumption of transit and canalization.

Laparoscopic intracorporeal anastomosis in the colon using the biofragmentable anastomotic ring--an animal study.

This experimental study examines the usefulness of a totally laparoscopic anastomotic technique in the colon with the aid of the biofragmentable anastomotic Valtrac ring and a newly developed applicator device. Following closed intracorporeal colonic resection with the linear stapler and subsequent re-opening of the proximal and distal bowel ends after placement of a pursestring suture, intracorporeal anastomosis was completed with the Valtrac ring. The technique was tested in 8 pigs. 6 pigs had no intra- or postoperative complications, while 2 pigs developed fatal peritonitis following anastomotic insufficiency in one pig and anastomotic stenosis caused by tilting of the Valtrac ring in the other animal. The results of the study show that handling of the biofragmentable anastomotic ring is facilitated by the use of the new application system. In the uncomplicated case, endoscopy and histology revealed bland healing with little scarring, and no evidence of an anastomotic stenosis.

New anastomotic gun for biofragmentable anastomotic ring in low anterior resection

The biofragmentable anastomotic ring remains difficult to use for low rectal anastomosis. The authors report their experience of clinical application of the biofragmentable ring in low anterior resection with a newly designed instrument. In this series, 31 patients underwent sphincter-preserving low anterior resections for rectal tumors from May 1993 to November 1994. With the assistance of a self-developed anastomotic instrument (biofragmentable anastomotic ring gun), biofragmentable ring anastomoses were performed following low anterior resection. There was no operative mortality. One patient had clinical evidence of anastomotic leakage. In postoperative follow-up, there was no anastomotic stenosis or incontinence. Therefore, we believe biofragmentable ring rectal anastomosis is a safe and reliable alternative to other anastomotic methods in rectal surgery.

The biofragmentable anastomotic ring (BAR) is associated with poor recovery of motility in the canine small bowel: [formula omitted], Departments of Surgery and Pathology, University of Florida College of Medicine and VAMC, Gainesville, FL

The biofragmentable anastomotic ring (BAR) is associated with poor recovery of motility in the canine small bowel: [formula omitted], Departments of Surgery and Pathology, University of Florida College of Medicine and VAMC, Gainesville, FL

New device for biofragmentable anastomotic ring in low anterior resection

The biofragmentable anastomotic ring (BAR) is now accepted as an alternative anastomotic method to handsewn and stapled anastomosis in colonic surgery. However, for a short rectal stump in a narrow pelvis, it is rather difficult to use the BAR in a low anterior resection. To overcome the difficulty, we designed and used a BAR-adapter to facilitate biofragmentable ring anastomosis following low anterior resection in eight patients with rectal cancers. There was no case in our series having received conversion to other methods. There was no significant complication associated with this technique. With the BAR-adapter, the applicability of the BAR can be greatly expanded in colorectal anastomosis following low anterior resection.

Laparoscopic assisted right hemicolectomy with Valtrac BAR (Biofragmentable Anastomotic Ring) ileotransverse anastomosis.

Laparoscopic techniques have been employed in a group of medically compromised patients requiring right hemicolectomy, permitting a shorter and lower placed abdominal incision than may have been expected with a conventional surgical approach. In eight patients requiring right hemicolectomy, full mobilization of the right colon from the caecum to the proximal transverse colon was performed laparoscopically. Resection and anastomosis then proceeded through a small right-sided transverse abdominal incision. End to end ileotransverse anastomosis was performed in each instance employing the Valtrac BAR (Biofragmentable Anastomotic Ring) compressive anastomotic technique. The average operating time was 133 min. There was no mortality, but one patient developed pulmonary complications and three developed minor wound infections. An additional three patients developed urinary tract infections. There were no anastomotic complications. The average postoperative stay was 10 days. This study has indicated that laparoscopic techniques can be successfully applied to large bowel surgery, and may be of benefit to high risk patients.

Comparison of bursting pressure of sutured, stapled and BAR anastomoses

The study was undertaken to compare anastomotic bursting pressure (ABP) of colorectal canine anastomoses using three different anastomotic techniques. Biofragmentable anastomotic ring (BAR), stapled, and sutured colon anastomoses were sequentially placed in each of 48 dogs following division of the colon at three equally spaced sites. Four groups of 12 dogs were sacrificed either on day 0, 3, 7, or 28 and ABP and bursting wall tension were determined. The data revealed that BAR anastomoses have the greatest strength on the day of surgery, sutured anastomoses are the strongest on the third day and all are comparable by the 7th day. Bursting pressures for all groups by day 28 approach normal colonic bursting pressure, with any differences likely to be a reflection of variation in anastomotic fibrosis and other factors.

Experience with the biofragmentable anastomotic ring (BAR) in bowel preoperatively irradiated with 6000 rad

Previous studies from the authors' laboratory using the biodegradable anastomotic ring (BAR) have demonstrated the safety of this device in animals irradiated preoperatively with the equivalent of 5000 rad; sutured, stapled, and BAR anastomoses all had leak rates of 10 percent or less in this setting. This study was undertaken to assess the safety of the BAR after irradiation with the equivalent of 6000 rad. Thirteen mongrel dogs underwent preoperative irradiation to the rectum and rectosigmoid, receiving 6000 rad according to the nominal standard dose equation. After a three-week rest period, each dog underwent anterior resection of the rectosigmoid and anastomosis with the BAR. The anastomoses were evaluated for early and late healing and anastomotic leaks. The results were compared with previous data from the authors' laboratory using an identical model. Radiographic leaks were found in 7 of 10 sutured anastomoses, 8 of 10 stapled anastomoses, and 3 of 13 BAR anastomoses (P less than 0.01). Comparative clinical leaks were 5 of 10 for sutured, 5 of 10 for stapled, and 3 of 13 for BAR anastomoses. These data suggest that the BAR may offer added safety to an anastomosis after preoperative irradiation. Whether this effect is due to the atraumatic technique of placing the device, improved blood flow to the anastomotic margins, or other factors, is still underdetermined.