Improving the side-to-side stapled anastomosis: comparison of staplers for robust crotch formation.

BACKGROUND: Few studies have investigated the burst pressure of side-to-side anastomoses comparing different stapling devices that are commercially available. OBJECTIVES: We conducted side-to-side anastomoses with a variety of staplers and compared burst pressure in the crotch of the anastomoses. SETTING: Nagoya City East Medical Center. METHODS: We conducted side-to-side anastomoses with 9 staplers with different shapes and forms. Fresh pig small intestines were used. A side-to-side anastomosis was performed between 2 intestine specimens using a linear stapler. The burst pressure of the anastomosis was recorded. RESULTS: In total, 45 staplers were used for this experiment. The site of leakage in all cases was the crotch. Regarding the influence of the number of staple rows, the burst pressure in 3-row staplers was significantly higher than in 2-row staplers. With regard to the relationship between staple height and burst pressure, staples with a height slightly shorter than the intestinal thickness showed the highest burst pressure. In a comparison of staplers with uniform staple heights and stamplers with staples of 3 different heights, the latter had significantly lower burst pressures. Neoveil significantly increased the burst pressure in the crotch and contributed to the highest burst pressure of all the staplers used in this experiment. CONCLUSIONS: In this experiment, we defined the important factors that influence burst pressure at the crotch of a stapled, side-to-side anastomosis. These factors include the number of staple rows, the height of the staple compared with the thickness of the tissue, uniformity of staple height, and reinforcement of the staple line. In any surgical case requiring intestinal anastomosis, selection of a stapler is a critical step.

Vascular control during laparoscopic kidney donation.

SUMMARY: Laparoscopic donor nephrectomy (LDN) is the gold standard for kidney donation. Recent literature has led to considerable debate regarding the safest route to provide vascular control during this procedure. The most common devices used for vascular control during LDN are staplers and surgical clips. Opinions regarding the safety of these devices vary, as both are prone to dysfunction. Certain clips have already been contraindicated for use on the donor artery owing to reports of catastrophic complications of falling off. Donor safety is paramount to the continued success of renal transplantation in Canada. A review of existing practice at each institution may be called for to ensure the safest standards possible are in place. An appendix to this commentary is available at canjsurg.ca.

Concept design and simulation study on a "phantom" anvil for circular stapler.

INTRODUCTION: Complications and challenges arising from the intraoperative double-stapling technique are seldom reported in colorectal surgery literature. Partial or full-thickness rectal injuries can occur during the introduction and the advancement of the circular stapler along the upper rectum. The aim of this study is to address some of these issues by designing and optimizing a "phantom" anvil manufactured to overcome difficulties throughout the rectal introduction and advancement of the circular stapler for the treatment of benign and malignant colon disease. METHODS: The design of the "phantom" anvil has been performed using computer-aided modeling techniques, finite element investigations, and 2 essential keynotes in mind. The first one is the internal shape of the anvil, which is used for the connection to the gun. The second is the shape of the cap, which makes possible the insertion of the gun through the rectum. The "phantom" anvil has 2 functional requirements, which have been taken into account. The design has been optimized to avoid colorectal injuries, neoplastic dissemination (ie, mechanical seeding) and to reduce the fecal contamination. RESULTS: Numerical simulations show that a right combination of both top and bottom fillet radii of the shape of the anvil can reduce the stress for the considered anatomic configuration of >90%. Both the fillet radii at the top and the bottom of the device influence the local stress of the colon rectum. CONCLUSIONS: A dismountable device, which is used only for the insertion and advancement of the stapler, allows a dedicated design of its shape, keeping the remainder of the stapler unmodified. Computer-aided simulations are useful to perform numerical investigations to optimize the design of this auxiliary part for both the safety of the patient and the ease of the stapler advancement through the rectum.

Improving safety and efficiency during emergent central venous catheter placement with a needleless securing clamp.

OBJECTIVE: To compare the needleless securing clamp to the traditional suture-secured clamp for central venous catheters. METHODS: Compare the holding strength of each type of clamps by measuring the amount of kinetic energy absorbed, ask 20 physicians to evaluate the clamp placement using sutures or staples, and summarise the clamps effectiveness and complications in 10 patients. RESULTS: Compared to sutured clamp, the needleless clamp was more secure. The needleless clamp was also significantly better with regard to ease of use, safety, perceived strength (p value <0.002), and insertion time was reduced by 63%. No adverse events or skin infections occurred while using the needleless clamps. CONCLUSIONS: Without incurring complications or increasing risk to patients, the needleless clamp is secure and improves safety and efficiency for physicians.

The unacknowledged incidence of laparoscopic stapler malfunction.

BACKGROUND: Laparoscopic instruments are being used with increasing frequency. Our surgeons recently experienced several independent adverse events involving the laparoscopic linear stapler. Although the Food and Drug Administration maintains a Manufacturer and User Facility Device Experience (MAUDE) database to track such voluntary reports, many events are not reported and the true incidence of adverse events is unknown. We attempted to determine how frequently minimally invasive surgeons have experienced technical problems with a laparoscopic stapler. METHODS: Following IRB approval, we electronically distributed an anonymous 10-question survey to the 124 minimally invasive program directors listed in the Fellowship Council database. The questions focused on personal or peer experience with laparoscopic stapler malfunction, frequency and type of malfunction, device manufacturer, whether the operation was altered, and root cause analysis of the event. RESULTS: Forty-four of the 124 program directors (35%) completed the survey. The majority reported personal or peer experience (86%) with a linear stapler not releasing (66%) or not firing (73%) after application, with 27% of the respondents noting that this occurred three or more times. The malfunction was not related to type of load, straight (23%) or reticulating (32%) model, or manufacturer (Ethicon 30%, Covidien 36%). One quarter of the respondents noted that the malfunction caused them to significantly alter their operative procedure, and 30% reported that they received no helpful feedback from the manufacturer despite contacting it. CONCLUSIONS: Most minimally invasive surgeons have experienced laparoscopic linear stapler malfunction and 25% have had to significantly alter the planned operative procedure due to the malfunction.

Comparison of endostapler performance in challenging tissue applications.

BACKGROUND: Surgical staplers are frequently used in a variety of applications, demanding exacting instrument performance over a huge range of tissue compositions and disease states. The shape of a staple that is formed by a stapling device is one industry-accepted indicator of device performance; typically a B-shaped staple is considered the gold standard for staple formation. This B shape allows blood flow through the tissue, which is one important factor in the healing events that take place clinically after stapling. With the use of an animal model, this ex vivo study investigated staple formation when thick tissue endoscopic staplers were used on challenging and variable tissue. The setting was a corporate institution in the United States. METHODS: Two 60-mm linear endoscopic thick tissue reloads, a varied-height stapler (VHS), and a single-height stapler (SHS) were fired on 7 different regions of porcine stomach. Resultant staple formation was assessed per region of the stomach and evaluated for proper B-shaped staple formation and staple malformation. RESULTS: The VHS reload had significantly better B-shaped formation (P<.001) for all regions of the stomach and reduced occurrence of malformed staples in 5 of the 7 regions compared with the SHS reload, wherein the remaining 2 regions exhibited comparable malform occurrence. CONCLUSIONS: This study compared 2 thick tissue reloads and found that the VHS reload had superior outcomes, with respect to staple formation, compared with the SHS reload.

Comparative study of a barbed suture, poliglecaprone and stapler in Pfannenstiel incisions performed for benign gynecological procedures: a randomized trial.

OBJECTIVE: To compare a novel barbed suture, poliglecaprone-25 suture and stapler in Pfannenstiel incisions performed for benign gynecological procedures. DESIGN: A randomized controlled non-inferiority trial with randomization in a 1:1:1 ratio. SETTING: Istanbul Dr. Lutfi Kirdar Kartal Research and Training Hospital, Department of Obstetrics and Gynecology. POPULATION: Patients between 18 and 45 years of age without prior lower abdominal incision and undergoing Pfannenstiel incisions for benign gynecological procedures. METHODS: A total of 117 female patients randomized into barbed (n = 39), poliglecaprone-25 (n = 39) and stapler (n = 39) groups according to suture type. Skin closure techniques were compared in terms of length of incision (cm), adverse events (wound dehiscence, incisional infection, seroma and hematoma), subjective pain scores, patient satisfaction and postoperative scar cosmesis. MAIN OUTCOME MEASURES. The difference between three suture materials in terms of postoperative incision pain, patient satisfaction and scar cosmesis. RESULTS: Skin closure techniques were similar in terms of length of incision (cm), adverse events and pain scores and Modified Hollander Cosmesis Score. Barbed (p < 0.001) and poliglecaprone-25 (p < 0.01) sutures were significantly better than staplers in terms of patient satisfaction. CONCLUSION: The three different methods of skin closure revealed comparable outcome except for a significant superiority of sutures to the stapler method in terms of patient satisfaction scores.

[Incident reports with surgical staplers]. / Vorkommnismeldungen bei Klammernahtinstrumenten.

BACKGROUND: The study was initiated to evaluate the risks of surgical staplers. METHODS: In the years 2002-2007, a total of 165 reports of incidents or corrective actions from 3 manufacturers were registered and retrospectively analyzed with respect to the prevalent product default appearance, the results of the manufacturer's investigations and the severity of the consequences for patient. RESULTS: Severe patient consequences occurred in only 35.2%. In the majority of the cases no patient injury resulted from the reported malfunction and the investigations revealed no product error (52.7%). CONCLUSION: The surgical staplers are predominantly safe for application in thoracic and abdominal surgery. The incident reports are important for risk assessment and improvement of the surgical staplers.

Stapled closed technique for laryngectomy and pharyngeal repair.

BACKGROUND AND AIMS: Total laryngectomy is a recognised treatment for advanced laryngeal carcinoma. Traditionally, pharyngeal repair is performed with layered sutures. We describe our experience with a technique of closed pharyngoplasty using a linear stapler device. MATERIAL AND METHODS: Ten total laryngectomies were performed from July 2002 to July 2004, using an Ethicon TLC 75 linear stapler for pharyngeal closure. Data collected included age, sex, staging, endoscopic assessment, surgical margins and post-operative course (including complications and swallowing). RESULTS: Patients comprised eight men and two women. The mean age was 55.4 years. Six patients had stage T4 endolaryngeal carcinoma and four had stage T3. Four patients underwent pre-operative radiotherapy. Clear surgical margins were achieved in all patients. One patient developed a pharyngocutaneous fistula. Patients resumed oral intake at 48 hours, or at 72 hours if they had undergone pre-operative radiotherapy. Patients' mean hospital stay was seven days. CONCLUSION: This stapled closed technique for pharyngoplasty is efficient and eliminates the risk of wound contamination, thus theoretically reducing the risk of tumour seeding. In addition, we were able to commence patients on oral fluids at a mean of 48 hours after surgery. The mean hospital stay was seven days. We recommend this technique as an alternative for repairing the pharynx in patients undergoing total laryngectomy for endolaryngeal carcinoma.

[Haemorrhoidectomy: conventional excision versus resection with the circular stapler. Prospective, randomized study]. / Hämorrhoidektomie: Konventionelle Exzision versus Resektion mit dem Klammernahtgerät. Prospektiv, randomisierte Studie.

BACKGROUND AND OBJECTIVE: The goal of this study was to compare two surgical methods of treating for haemorrhoids that aim at closure of the wound: resection with a circular stapler and a conventional, closed haemorrhoidectomy. PATIENTS AND METHODS: 80 patients (41 males, mean age 47,1 years) with haemorrhoids stage 3 were randomized and treated with stapler haemorrhoidectomy (test group; n = 40) or had an haemorrhoidectomy according to Fansler and Anderson (control group; n = 40). Following a standardized study protocol we compared postoperative results on the operating day and one week, six weeks, six months and one year afterwards uni- and multivariate analysis and we also calculated the costs. RESULTS: The stapler haemorrhoidectomy proved to be the method causing significantly reduced pain in the early postoperative period so that the patients needed less pain relief. They were able to return to work earlier. One year after stapler haemorrhoidectomy there were three episodes of postoperative bleedings that required intervention, one in the control group. Six patients still had haemorrhoids stage 3, six patients over the age of 65 had persistent anal incontinence (I degrees according to Parks) with proven sphincter dysfunction and disturbances in voiding their bowel with resulting deterioration of quality of life, significantly more frequent than in the control group. CONCLUSIONS: Stapler haemorrhoidectomy cures stage 3 haemorrhoids on a long term basis in 84.2 % of patients, costing less than all alternative treatments. In some cases, it can be associated with postoperative complications.

Before a surgical stapler fails....

Surgical staplers are complex mechanical devices that require skill and experience to operate. In several cases in which a stapler failed--and may have led to patient injury--staff reported having difficulties with the device before the actual failure. Unfortunately, surgical staff was undeterred by the warning signs and continued to use the device. In some cases, this decision led to patient injuries. In this Guidance Article, we advise users on how to deal with stapler failures. In particular, we focus on those that are preventable--instances in which staplers warn of the impending failure.

Prospective comparative evaluation of stapled versus transected silastic ring gastric bypass: 6-year follow-up.

BACKGROUND: The effect of transecting vs. stapling the stomach in continuity in the banded gastric bypass (GBP) operation was studied. METHOD: 50 patients, 25 in each group, were enrolled into a prospective study to determine if transecting the stomach vs. stapling it in continuity in performing GBP for obesity decreases the incidence of gastro-gastric fistula formation without increased morbidity. RESULTS: The patient profiles in the 2 groups were very similar. The peri-operative complications included 1 splenic capsular injury in each group, controlled without a splenectomy. There was 1 anastomotic leak in the stapled and 1 bleeding from the cut edge of the bypassed stomach in the transected group, both requiring re-operations in the immediate postoperative period. There was no peri-operative mortality. The percent follow-up after 6 years was 80% and 88% in the stapled and transected groups respectively. The incidence of late complications of solid food intolerance, ventral incisional hernia, cholelithiasis and small bowel obstruction was similar in both groups. There were 8 gastro-gastric fistulas in the stapled group and 1 in the transected group. The reduction in body mass index and percent excess weight loss (66%) were similar in both groups. CONCLUSION: The incidence of gastro-gastric fistula may be reduced in GBP procedures by transecting the stomach as opposed to stapling it in continuity, without an increase in morbidity or mortality or any loss in the effectiveness of the operation.

[DIN-oriented tensile strength evaluation of surgical tissue sutures]. / DIN-orientierte Festigkeitsprüfung chirurgischer Gewebeverbindungen.

Methods to determine the mechanical properties of surgical wounds and sutures are valuable tools in wound healing research. So far standardized testing procedures have not been defined in the surgical literature, which reduces the comparability of results from different authors. Therefore we suggest a modified tensile testing procedure which follows German industrial standards (DIN 53455). The experimental set-up includes an universal testing machine and special clamps. The dumbbell-shaped specimen consist of freshly prepared pig skin and the suture which is to be tested. Well-known mechanical properties of surgical sutures and wounds were used to approve the precision of the experimental set-up. Reproducible analysis of all tested sutures and wounds (n = 120) was possible. We recommend testing procedures adapted to industrial standards to obtain comparable results in determination of mechanical properties of surgical wounds and sutures.

Stapled anastomosis in esophageal resections with Chinese staplers: a retrospective study of 1965 consecutive cases.

OBJECTIVES: To investigate the safety and efficacy of mechanical anastomosis with Chinese staplers in the surgical treatment of esophageal carcinoma and carcinoma of gastric cardia in order to find out an alternative effective anastomotic technique to hand-sewn method. METHODS: From August 1980 to April 1996, there were totally 1264 cases of esophageal carcinoma and 701 cases of carcinoma of gastric cardia receiving esophagogastric anastomosis with Chinese staplers combined with telescope suturing of seromuscular layers after resection of tumors, with age ranging from 28 years to 81 years and a man to woman ratio of 4:1 (1572/393). The anastomosis was performed at the cervical region in 44 patients, and intrathoracically in 1921. Our technical essential points also included fixation of the gastric substitute to the thoracic apex or mediastinum with 3-4 stitches to relieve the anastomotic tension. RESULTS: Compared with the reported postoperative leakage rate from 2%-4% in China and 4.2%-12.3% abroad, our techniques reduced the total leakage rate to 0.8%, that is, cervical leakage rate was 11.4% (5/44), and intrathoracic leakage rate 0.57% (11/1921). The intrathoracic leakage rate was 0.99% (8/808) for the first 8 years, and 0.27% for the following 8 years. There was no leakage (0/350) in the last 3 years. There anastomotic stricture occurred in 98 patients (4.99%) which could be relieved by Bougie or balloon dilatation. The total operative mortality was reduced to 0.76%. CONCLUSIONS: Mechanical anastomosis with Chinese staplers combined with telescope suturing should be an effective method to prevent the occurrence of anastomotic leakage after esophageal resections.

A newly designed miniplate staple for high tibial osteotomy.

A biomechanical study was made to compare the mechanical performance of the newly designed Miniplate staple to the conventional Coventry staple in high tibial osteotomy (HTO). Using twenty fresh porcine tibiae, the fixational strength of the two different types of staples in HTO was compared. To minimize the error due to the specimen-to-specimen individuality, the bone mineral density of the tibiae was measured with bone densitometry and those with 0.8 to 1.2 gm/cm2 at the proximal tibia were used in the biomechanical test. Testing was performed on a material testing system with aid of a commercial data processor. Using two different loading modes, "pull-out" and "push-out," the maximum resistant force required to release the staple from the substrate bone was recorded. In the pull-out test, ten nonosteotomized specimens were used and the staple was pulled out by subjecting an axial tension on the head of the staple inserted. In the push-out test ten tibiae osteotomized in the usual method of HTO were used and the staple was not directly loaded. In this testing, as a mimic condition of the natural knee, the proximal part of the specimen tibia was pushed horizontally in order for the staple to be pulled out while the distal tibia was fixed. The pull-out strength of Coventry staple and Miniplate staple were found to be 27.88 +/- 5.12 kgf and 182.47 +/- 32.75 kgf, respectively. The push-out strength of Coventry staple and Miniplate staple were 18.40 +/- 4.47 kgf and 119.95 +/- 19.06 kgf, respectively. The result revealed that the Miniplate staple has both a pull-out and push-out strength that is more than six times higher than Coventry staple. Based on the data, it is believed that the Miniplate staple provides better postoperative fixation in HTO. The postoperative application of long leg casting may not be needed after HTO surgery.