Standardised Sleeve Gastrectomy Without Reinforcement.

BACKGROUND AND OBJECTIVES: Laparoscopic sleeve gastrectomy (LSG) has some unique complications, the most concerning of which is sleeve leak. Staple line reinforcement (SLR) has been suggested as a means of decreasing the risk of sleeve leak, but it increases the cost. However, there is little in the literature regarding the effect of standardized operative technique in reducing the complications and improving the outcomes in LSG. We sought to demonstrate that standardization of the operative procedure and perioperative care is the key to an excellent 30-day outcome and that SLR is not necessary to ensure a negligible staple line leak and bleeding rate. METHODS: A prospectively maintained database was analyzed to identify 303 consecutive patients undergoing LSG between July 2010 and November 2017. Data on patient demographics, length of hospital stay, conversion to open surgery, perioperative complications, and mortality were analyzed. Standardized operative technique and postoperative protocol were followed in all cases. SLR was not used in any case. RESULTS: Among 303 cases, there were 15 complications (5%), 5 (1.7%) of which were severe (Clavien-Dindo grade ≥3a). There were no conversions to open procedure, no staple line leaks, and no inpatient deaths in the cohort. No patient was readmitted with an early stricture. CONCLUSIONS: The use of a standardized operative and postoperative protocol led to an excellent early outcome in our LSG cases. Standardization may act to obviate the need for routine SLR techniques which are associated with a significant financial cost to both patient and hospital.

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.

Individual surgeon is an independent risk factor for leak after double-stapled colorectal anastomosis: An institutional analysis of 800 patients.

BACKGROUND: Our aim was to assess whether the individual surgeon is an independent risk factor for anastomotic leak in double-stapled colorectal anastomosis after left colon and rectal cancer resection. METHODS: This retrospective analysis of a prospectively collected database consists of a consecutive series of 800 patients who underwent an elective left colon and rectal resection with a colorectal, double-stapled anastomosis between 1993 and 2009 in a specialized colorectal unit of a tertiary hospital with 7 participating surgeons. The main outcome variable was anastomotic leak, defined as leak of luminal contents from a colorectal anastomosis between 2 hollow viscera diagnosed radiologically, clinically, endoscopically, or intraoperatively. Pelvic abscesses were also considered to be an anastomotic leak. Radiologic examination was performed when there was clinical suspicion of leak. RESULTS: Anastomotic leak occurred in 6.1% of patients, of which 33 (67%) were treated operatively, 6 (12%) with radiologic drains, and 10 (21%) by medical treatment. Postoperative mortality rate was 2.9% for the whole group of 800 patients. In patients with anastomotic leak, mortality rate increased up to 16% vs 2.0% in patients without anastomotic leak (P < .0001). At multivariate analysis, rectal location of tumor, male sex, bowel obstruction preoperatively, tobacco use, diabetes, perioperative transfusion, and the individual surgeon were independent risk factors for anastomotic leak. The surgeon was the most important factor (mean odds ratio 4.9; range 1.0 to 13.5). The variance of anastomotic leak between the different surgeons was 0.56 in the logit scale. CONCLUSION: The individual surgeon is an independent risk factor for leakage in double-stapled, colorectal, end-to-end anastomosis after oncologic left-sided colorectal resection.

[The technique of restorative proctocolectomy with ileal J­pouch : Standards and controversies]. / Technik der Proktokolektomie mit ileoanalem Pouch : Standards und Kontroverses.

BACKGROUND: Restorative proctocolectomy (RPC) is the standard of care in the case of medically refractory disease and in neoplasia in ulcerative colitis (UC). OBJECTIVES: This review aims at providing an overview of the current evidence on standards, innovations, and controversies with regard to the surgical technique of RPC. RESULTS: RPC is the standard of care in the surgical management of UC refractory to medical treatment and in neoplasia. Due to its simplicity and good functional outcomes, the J­pouch is the most used pouch design. RPC is usually performed as a two-stage procedure. In the presence of risk factors, a three-stage procedure should be performed. The technically more demanding mucosectomy and hand sewn anastomosis does not seem to result in a better oncologic outcome than stapled anastomosis. Functional results appear marginally better after stapled anastomosis, but the rectal cuff should not exceed 2 cm in this reconstruction. The laparoscopic approach is at least as good as the open approach. For the new, innovative surgical approaches such as robotics and transanal surgery, only feasibility but no advantages have yet been demonstrated. CONCLUSION: The evidence in regard to controversial points remains limited.

A Thickness Calibration Device Is Needed to Determine Staple Height and Avoid Leaks in Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Leaks after sleeve gastrectomy (SG) may be due to a mismatch between staple height and tissue thickness. The aim of this study was to determine the range of gastric thicknesses in three areas of stapling. METHODS: SG was performed using a 40-Fr suction calibration system 4 cm from the pylorus. Measurement of combined gastric walls was accomplished with an applied pressure of 8 g/mm(2) on the fundus, midbody, and antrum. RESULTS: We enrolled 26 SG patients (15 women, 11 men; mean age 36.8 years). Body mass index (BMI) averaged 45.3 kg/m(2) overall, 44.7 kg/m(2) for males and 45.7 kg/m(2) for females. Although male patients had a thicker stomach antrum than female patients (3.12 vs. 3.09 mm), the midbody (2.57 vs. 3.09 mm) and proximal areas (1.67 vs. 1.72 mm) were thicker in female patients. However, some maximum fundus thicknesses were up to 2.83 mm in females and 2.28 mm in males. Some antra were as thick as 4.07 mm in females and 5.39 mm in males. Also, men had a longer average staple line (22.95 vs. 19.90 cm). CONCLUSION: Because of the range of gastric thicknesses, a single staple height cannot be used to appose the full range of gastric wall thicknesses without potentially causing necrosis or poor apposition. To help avoid leaks, a thickness calibration device is needed to determine correct staple height.

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.

Face, content and construct validity of a new realistic trainer for conventional techniques in digestive surgery.

PURPOSE: Surgical simulation modules for "open" surgery are limited in contrast to well-studied and validated laparoscopic trainers. In this study, face, content and construct validity of a devised simulation module (Berlin Operation Trainer, BOPT) for handsewn anastomoses in digestive surgery were analysed. MATERIALS AND METHODS: Participants of a skills course for digestive surgery (novices: 1-3 years of training; experts: more than 5 years of training) were timed on performing four defined handsewn digestive anastomoses on formalin fixed porcine intestine in the BOPT. Questionnaires were answered regarding impression with the simulation module concerning appearance and realism using a five-point Likert and a three-point forced choice scale. Face and content validities were evaluated based on the responses of participants and construct validity by comparing novices to experts. Data collected were analysed with Fisher's exact test and two-sample t test. RESULTS: Twenty-two novices (median: second postgraduate year) and 26 experts (median: seventh postgraduate year) were enrolled in the study. The BOPT showed strong face and content validities with average scores for satisfaction parameters above 4.2 +/- 0.41 and 4.1 +/- 0.22, respectively. Construct validity was adequate for anastomosis simulation in the BOPT based on different percentages of anastomosis complete during set time between novices and experts as shown for simple (68.2% vs. 92.3%, p = 0.038) and for difficult anastomosis (18.2% vs. 50.0%, p = 0.021). CONCLUSIONS: The BOPT is a suitable instrument for advanced surgical training for novices and experienced colleagues creating a realistic and demanding situation. Further studies have to evaluate if a more realistic preoperative training will support an effective transfer of learned techniques to the operating room.

Standardization of the fully stapled laparoscopic Roux-en-Y gastric bypass for obesity reduces early immediate postoperative morbidity and mortality: a single center study on 2606 patients.

BACKGROUND: Various techniques of laparoscopic Roux-en-Y gastric bypass have been described. We completely standardized this procedure to minimize its sometimes substantial morbidity and mortality. This study describes our experience with the standardized fully stapled laparoscopic Roux-en-Y gastric bypass (FS-LRYGB) and its influence on the 30-day morbidity and mortality. METHODS: We retrospectively analyzed 2,645 patients who underwent FS-LRYGB from May 2004 to August 2008. Operative time, hospital stay and readmission, re-operation, and 30-day morbidity/mortality rates were then calculated. The 30-day follow-up data were complete for 2,606 patients (98.5%). RESULTS: There were 539 male and 2,067 female patients. Mean age was 39.2 years (range 14-73), mean BMI 41.44 kg/m(2) (range, 23-75.5). The mean hospital stay was 3.35 days (range 2-71). Mean total operative time was 63 min (range 35-150). One patient died of pneumonia within 30 days of surgery (0.04%). One hundred and fifty one (5.8%) patients had postoperative complications as follows: gastrointestinal hemorrhage (n = 89, 3.42%), intestinal obstruction (n = 9, 0.35%), anastomotic leak (n = 5, 0.19%) and others (n = 47, 1.80%). In 66 patients, the bleeding resolved without any surgical re-intervention. One hemorrhage resulted in hypovolemic shock with subsequent renal and hepatic failure. CONCLUSION: The systematic approach and the full standardization of the FS-LRYGB procedure contribute highly to the very low mortality and the low morbidity rates in our institution. Gastrointestinal bleeding appears to be the commonest complication, but is self-limiting in the majority of cases. Our approach also significantly reduces operative time and turns the technically demanding laparoscopic Roux-en-Y gastric bypass procedure into an easy reproducible operation, effective for training.

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.

Application of Six Sigma towards improving surgical outcomes.

BACKGROUND/AIMS: Six Sigma is a 'process excellence' tool targeting continuous improvement achieved by providing a methodology for improving key steps of a process. It is ripe for application into health care since almost all health care processes require a near-zero tolerance for mistakes. The aim of this study is to apply the Six Sigma methodology into a clinical surgical process and to assess the improvement (if any) in the outcomes and patient care. METHODOLOGY: The guiding principles of Six Sigma, namely DMAIC (Define, Measure, Analyze, Improve, Control), were used to analyze the impact of double stapling technique (DST) towards improving sphincter preservation rates for rectal cancer. RESULTS: The analysis using the Six Sigma methodology revealed a Sigma score of 2.10 in relation to successful sphincter preservation. This score demonstrates an improvement over the previous technique (73% over previous 54%). CONCLUSIONS: This study represents one of the first clinical applications of Six Sigma in the surgical field. By understanding, accepting, and applying the principles of Six Sigma, we have an opportunity to transfer a very successful management philosophy to facilitate the identification of key steps that can improve outcomes and ultimately patient safety and the quality of surgical care provided.

Initial experience with stapled hemorrhoidopexy for treatment of hemorrhoids / Experiência inicial com o tratamento da doença hemorroidária pela técnica de grampeamento circular

BACKGROUND: Introduction of stapled hemorrhoidopexy by Longo in 1998 represented a radical change in the treatment of hemorrhoids. By avoiding multiple excisions and suture lines in the perianal region, stapled hemorrhoidopexy is intended to offer less postoperative pain than with conventional techniques. OBJECTIVE: To report and analyze the intra and postoperative results gained during initial experience with stapled hemorrhoidopexy. METHODS: One hundred and fifty five patients (67 males) with average age of 39.5 years (21-67 years) underwent stapled hemorrhoidopexy between June 2000 and December 2003 with symptomatic third-degree (n = 74) and fourth-degree (n = 81) hemorrhoids. Mean follow-up period was 20 months (14-60 months). RESULTS: Preoperative symptoms were prolapse (96.7 percent) and anal bleeding (96.1 percent). Overall mean operative time was 23 minutes (16-48 minutes). We observed one case of stapler failure and one case of failure to introduce the stapler occurred in a patient with previous anal surgery. Additional sutures for hemostasis were required in 103 patients (66.5 percent). Resection of skin tags was performed in 45 cases (29 percent). Postoperatively scheduled analgesia with oral dipyrone and celecoxib was enough for pain control in 131 patients (84.5 percent). Rescue analgesia was necessary in 24 cases (15.5 percent). Five patients needed opiates for pain control. Hospital discharge took place on the first postoperative day in 140 patients (90.3 percent). First defecation without pain was reported by 118 patients (76.1 percent). Postoperative complications were anal bleeding (10.3 percent), severe pain (3.2 percent), urinary retention (3.9 percent), fever without any signs of perianal infection (1.9 percent), incontinence for flatus (1.9 percent), hemorrhoidal thrombosis (1.3 percent). Two patients presented symptoms of recurrent hemorrhoidal disease and were successfully treated by conventional hemorrhoidectomy. They were no cases of...

RACIONAL: A introdução por Longo em 1998, da hemorroidopexia pela técnica de grampeamento circular representou uma mudança radical no tratamento cirúrgico da doença hemorroidária, ao passo que propõe o reposicionamento da mucosa anorretal prolapsada, sem excisão do mamilo hemorroidário, cursando assim com menor dor e menor tempo de recuperação pós-operatórios. OBJETIVO: Apresentar e analisar os resultados intra e pós-operatórios obtidos durante a experiência inicial com a técnica de grampeamento circular. PACIENTES E MÉTODO: Foram incluídos 155 pacientes (67 homens) com média de idade de 39,5 anos (21-67 anos) e doença hemorroidária sintomática grau III (n = 74) e IV (n = 81), operados consecutivamente pelo método do grampeamento circular entre junho de 2000 e dezembro de 2003. Resultados e complicações pós-operatórias foram aferidos num tempo de seguimento médio de 20 meses (14-60 meses). RESULTADOS: Os principais sintomas pré-operatórios foram prolapso (96,7 por cento) e sangramento (96,1 por cento). O tempo operatório médio foi de 23 minutos (16-48 minutos). Houve um caso de falha do equipamento e um de impossibilidade de introdução do mesmo (paciente com cirurgia anal prévia). Hemostasia adicional com sutura foi necessária em 103 pacientes (66,5 por cento) e a ressecção de plicomas foi realizada concomitantemente ao procedimento em 45 pacientes (29 por cento). A analgesia pós-operatória via oral com dipirona e celecoxib foi eficiente no controle da dor em 131 pacientes (84,5 por cento), 24 (15,5 por cento) necessitaram de analgesia complementar, sendo que 5 pacientes receberam opióides devido a dor intensa. A maioria dos pacientes (140 - 90,3 por cento) teve alta no primeiro dia de pós-operatório e 118 (76,1 por cento) referiram a primeira evacuação sem dor. As complicações pós-operatórias observadas foram: sangramento (10,3 por cento), tenesmo (3,9 por cento), retenção urinária (3,9 por cento), febre sem sinais infecciosos (1,9 por cento), incontinência...

[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.

Tensile strength of mesh fixation methods in laparoscopic incisional hernia repair.

BACKGROUND: Fixation of the mesh is crucial for the successful laparoscopic repair of incisional hernias. In the present experimental study, we used a pig model to compare the tensile strengths of mesh fixation with helical titanium coils (tackers) and transabdominal wall sutures. METHODS: Thirty-six full-thickness specimens (5 x 7 cm) of the anterior abdominal wall of nine pig cadavers were randomized for fixation of a polypropylene mesh (7 x 7 cm) by either tackers or transabdominal wall sutures. The number of fixation points varied from one to five per 7-cm tissue length, with distances between fixation points of 2.3, 1.8, 1.4, and 1.2 cm, respectively. The force required to disrupt the mesh fixation (tensile strength) was measured by a dynamometer. Statistical analysis was performed using the Wilcoxon test and the Spearman rank correlation test. RESULTS: The mean tensile strength of mesh fixation by transabdominal sutures was significantly greater than that by tackers for each number of fixation points: 67 N vs 28 N for a single fixation point (p <0.001), 115 N vs 42 N for two fixation points (p <0.001), 150 N vs 63 N for three fixation points (p <0.05), 151 N vs 73 N for four fixation points (p <0.05), and 150 N vs 82 N for five fixation points (p <0.05). Increasing the number of fixation points over three per 7 cm (distance between fixation points of 1.8 cm) did not improve tensile strength. CONCLUSION: The tensile strength of transabdominal sutures is up to 2.5 times greater than the tensile strength of tackers. Therefore, the use of transabdominal sutures for mesh fixation appears to be preferable for laparoscopic incisional hernia repair.

Evaluation of a skin stapler for belt-loop gastropexy in dogs.

A new method for attachment of a belt-loop gastropexy using disposable, stainless steel skin staples was compared with a traditional hand-sewn belt-loop gastropexy technique in 24 fresh dog cadavers. Mean gastropexy times were 212 seconds for the stapled technique and 435 seconds for the hand-sewn technique. The stapled belt-loop gastropexy was significantly faster than the hand-sewn technique (P less than 0.001). There was no statistically significant difference in the mean maximum tensile strength between the two attachment methods. This study provides a basis for clinical evaluation of the stapled belt-loop gastropexy technique in dogs.

Comparison of staples vs suturing for securing central venous catheters.

OBJECTIVE: To determine whether skin staples can be used to secure central venous catheters as effectively as does suturing. METHODS: A prospective, randomized trial of techniques to secure a central venous catheter was performed in a medical school human anatomy laboratory using human cadavers. Central lines were secured to the upper left thorax using either standard suture material (000 silk) or skin staples (5.7 mm x 3.8 mm). Once secured, an upward force was applied to the hub of the catheter perpendicular to the skin. The amount of force needed to break the catheter hub free of the skin was measured in kg. A total of 10 measurements were made for each of 3 methods for securing the catheters (2 sutures, 2 staples, 4 staples). In addition, the site of catheter breakage was recorded. RESULTS: Those catheter hubs secured by 2 sutures required a mean force of 3.1 +/- 0.5 kg to cause breakage, and the break always occurred at the suture. Those hubs secured by 2 staples gave way at 3.0 +/- 0.3 kg (p = NS), while those secured with 4 staples gave way at 4.5 +/- 1.4 kg (p < 0.05). Although 1 hub did break, in all other stapled cases, the break occurred at the staple. CONCLUSIONS: Based on this cadaver model, use of staples appears to be as effective as suturing for securing central venous catheters. Further studies of safety and time for placement are needed.