Ethicon Endo-Surgery Research Articles

Thoracoscopic hepatectomy for malignant liver tumor

Anatomical position of the liver poses a difficulty in approaching the lesions using a laparoscopic approach. The patient was a 79-year-old man with a surgical history of laparoscopic sigmoidectomy for colon cancer and posterior segmentectomy of the liver for metastatic liver tumor. On admission, he presented with another liver tumor (diameter, 1.5 cm) in the dome of segment VIII. Because of the high possibility of severe adhesion around the liver and difficulty of approaching the lesion from the abdomen, we selected the transthoracic approach rather than the abdominal approach; the patient consented to this procedure. The patient was placed in the left-lateral position under general anesthesia with single-lung ventilation. We placed three trocars into the right thoracic space. The intrathoracic space was observed using a flexible-tip rigid scope (Olympus, Tokyo, Japan). The tumor was detected by inserting a flexible laparoscopic ultrasound probe (Hitachi Aloka, Ltd., Tokyo, Japan) through the diaphragm; the diaphragm was dissected immediately above the tumor using a harmonic scalpel (Ethicon Endo-Surgery, Inc., Cornelia, GA). The liver surface was precoagulated using a low-voltage monopolar coagulator with a ball-shaped tip (Amco Inc., Tokyo, Japan) with the electrosurgical unit VIO300D (Erbe Elektromedizin, Tuebingen, Germany). The parenchyma was first sealed using BiClamp LAP forceps (Erbe Elektromedizin) and divided using the harmonic scalpel. The specimen was extracted using a retrieval bag. After complete hemostasis was achieved, the diaphragm was closed by continuous suturing. The operation lasted for 310 min and estimated blood loss was 10 mL. The patient was discharged on postoperative day 4. Although the duration of TH was long because of the narrow thoracic cavity space, TH was performed without any problems. As a rule, we should select TH for lesions located in the dorsal segment VII/VIII, with severe adhesion around the liver.

MINIMALLY INVASIVE OPEN THYROIDECTOMY IN THYROID CANCER WITH COEXISTENT HASHIMOTO THYROIDITIS

One of the minimally invasive thyroidectomy challenges is the application of this technique in the surgical treatment of thyroid cancer. The use of minimally invasive open approach in co-existence of thyroid cancer with Hashimoto thyroiditis is well known provocation to the skills of the surgeon working in the field of thyroid surgery. Aim: To report our results and to present the possibilities of minimally invasive open approach in the surgical treatment of thyroid carcinoma and coexistent Hashimoto thyroiditis. Patients and methods: For the period from 2008 to 2011, 641 patients were operated on in our clinic using minimally invasive open approach. In 32 of these patients presence of Hashimoto thyroiditis was found in combination with thyroid cancer. All patients were females, 26 to 46 years age. Patients were selected according to designed and accepted for our institution criteria. The procedures were performed using ultrasound (harmonic) shears (Harmonic Focus® and Harmonic Ace®, Ethicon Endo-Surgery). The operative time, incidence, type and severity of complications, length of hospital stay, safety and reliability of the surgical procedure were analyzed. Results: The operative incision length in all cases was between 2.0-2.5 cm. In 27 patients papillary thyroid carcinoma and in 5 patients – follicular variant of the neoplasm were found. The tumor size ranged between 0.5 and 1.5 cm. In all patients total thyroidectomy using harmonic scalpel was performed. Lymph node metastases in the central neck compartment were not found in any of the cases. The rate, type and severity of complications did not exceed those for patients who underwent conventional thyroidectomy. All patients leaved the hospital in the first 24 postoperative hours. The follow-up did not reveal remnant thyroid tissue in thyroid gland bed or recurrence of the disease. Conclusions: Our results demonstrate the feasibility and reliability of minimally invasive open approach with harmonic scalpel in the surgical treatment of carefully selected patients with non-advanced thyroid cancer and coexistent Hashimoto thyroiditis

THE HARMONIC SCALPEL APPLICATION IN THYROID SURGERY

New, modern devices for tissue resection have been introduced in the surgical treatment of thyroid diseases recent years. Aim: To present our experience with the use of the harmonic scalpel in thyroid surgery. Patients and methods: For the period 2008 2011, 1398 patients (6 to 74 years old) with various thyroid deseases were operated on in our clinic. The resection was performed through a classic Kocher , s collar incision in 583 patients, using minimally ivasive open access in 641 patients and with video-assisted technique in 174 patients. In all patients a harmonic scalpel device (Ethicon Endosurgery Care Inc) has been used. The length of surgical incision, use of haemostatic instruments and ligatures, extent of resection, need of draining, operative time, intra- and postoperative complications, length of postoperative hospital stay have been examined . Results: The volume of resection ranged from istmusectomy to total thyroidectomy. During all operation haemostatic instruments and ligatures have not been used. Lack of bleeding and shortend operating time - up to 45% were found. The use of draining is significantly reduced, regardless of the extent of resection. There was no increase in the incidence of intra- and postoperative complications.Ohe postoperative stay was significantly reduced. Conclusion: In our opinion, the introduction in use of the harmonic scalpel changes the face of modern thyroid surgery providing reliable hemostasis and shortening the operating time significantly.

Transanal minimally invasive surgery (TAMIS) using a new disposable device: our initial experience

Disposable single-port surgery devices have been used for transanal minimally invasive surgery (TAMIS). Their advantage, compared to transanal endoscopic microsurgery, is that they do not require special equipment or training. The aim of this study was to assess our initial experience using the single-site laparoscopic (SSL™) access system (Ethicon Endo-Surgery, Cincinnati, OH, USA) for TAMIS. Five patients eligible for local excision of rectal tumors, four males and one female, mean age 58years (range 50-78), underwent surgery using the SSL™device. The average distance from anal verge was 4cm (range 1-6). Four patients had an initial diagnosis of adenoma, and one had a previous endoscopic excision of a T1 adenocarcinoma with positive margins. In one patient, due to the lack of exposure, the procedure was converted to a low anterior resection. In the remaining four patients, average setup time was 7minutes (range 4-15) and average operative time was 52minutes (range 38-72). All resection margins were tumor free. There were no postoperative complications. Two of the presumed adenomas were intramucosal adenocarcinomas, while one patient had a T2 tumor and underwent radical surgery. Although at the present time the appropriate use of local excision is still under debate, TAMIS is a technique with great potential. Because of its simplicity and similarity with conventional laparoscopic surgery, it can be learned easily by surgeons not trained in transanal endoscopic microsurgery.

OC-084 A Comparative Study of Clinical outcomes after Laparoscopic or Open Restorative Proctocolectomy

Introduction Laparoscopic colorectal surgery confers significant benefits over similar open procedures. A paucity of data exists examining this in restorative proctocolectomy, although recent literature has suggested reduced adhesions and improved fertility. We assessed consecutive patients undergoing laparoscopic ileal pouch anal anastomosis (IPAA), comparing clinical outcomes with those following conventional open surgery. Methods 207 consecutive patients undergoing IPAA between November 2006 and November 2011 were assessed [76 (37%) laparoscopic procedures and 131 (67%) open cases were included]. A careful collaborative approach to developing the new technique was undertaken during the first two years in this high volume centre. Data were collected prospectively on a dedicated database. Study endpoints included post-operative length of stay, 30 day morbidity [Clavien-Dindo classification(C-D)], readmission, reoperation, pouch function & failure. Results There were no significant differences in patient age, sex, BMI or previous abdominal surgery between the two groups. Conversion rate was 9%; Median operative time was significantly shorter for open surgery – 208 (IQR 178–255) versus 285 minutes (IQR 255–325); p Laparoscopy significantly reduced length of stay: median 6 days (IQR 4.25–8), v 8 days (IQR 7–12); p Minor [C-D I/II] complications were significantly reduced with laparoscopy (32.8% v 50.4%: OR 0.48 [95%CI 0.27–0.87]). Complications [all grades] were reduced non-significantly after laparoscopic surgery There were no significant differences in total complications – 51.3% after laparoscopy versus 61.5%: OR 0.66 [95%CI 0.37–1.17], anastomotic leak rate, major morbidity, 30 day readmission, reoperation and stoma closure rates. Pouch failure has occurred in 14 patients (7.7%) overall, however there were 12 (11%) in the open group with only 2 (2.6%) in the laparoscopic group, although this is not statistically significant (P = 0.172). No significant difference was seen in pouch dysfunction rates. Conclusion Laparoscopic restorative proctocolectomy significantly reduces length of stay and minor morbidity and can be offered to an increasing proportion of restorative proctocolectomy patients. A careful collaborative developmental process has occurred in a high volume centre to achieve these results. Disclosure of Interest I. White: None Declared, J. Jenkins: None Declared, R. Coomber: None Declared, S. Clark: None Declared, R. Phillips: None Declared, R. Kennedy Grant/Research Support from: Ethicon Endosurgery and Olympus UK Reference Dindo D., Demartines N., Clavien P.A.; Classification of Surgical Complications. Ann Surg. 2004; 244: 931–937.

Utility of a microwave surgical instrument in sealing lymphatic vessels

BackgroundThis study assessed the ability of a novel microwave coagulation surgical instrument (MWCX) to seal lymphatic vessels when compared with LigaSure (Valleylab, Boulder, CO), the Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH), and electric cautery. MethodsThe burst pressure of pig inguinal lymphatic vessels was assessed after the sealing of vessels with each surgical instrument. The rate of lymphorrhea from pig mesenteric lymphatic vessels was also investigated using indocyanine green and visualized with the Photodynamic Eye system (Hamamatsu Hotoniks, Hamamatsu, Japan). ResultsBurst pressures were higher with MWCX (average, 300 mm Hg), LigaSure (average, 290 mm Hg), and HS (average, 253 mm Hg) when compared with electric cautery (average, 152.3 mm Hg; vs MWCX: P = .002, vs LigaSure: P = .002, vs HS: P = .004). The rate of lymphorrhea was significantly lower with LigaSure (13.3%), HS (18.8%), and MWCX (13.3%) when compared with electric cautery (77.3%; vs LigaSure: P < .001, vs HS: P < .001, vs MWCX: P < .001). ConclusionsMWCX was equivalent to LigaSure and HS in terms of the ability to seal lymphatic vessels.

Multidisciplinary laparo-endoscopic management of a subcardial gastric diverticulum

A 46-year-old obese female patient presented in the emergency room with acute exacerbation of abdominal pain, recurring nausea and vomiting, and a history of chronic pain in the lumbar spine. An external report of recently taken magnetic resonance images described a suspicious left adrenal mass ([Fig. 1]). The patient also had reflux symptoms and fetor ex ore. A history of rapid weight loss of 16 kg over the past 3 months and increasing fatigue raised suspicion for malignant disease. Assessment for pheochromocytoma was negative. A computed tomography (CT) scan excluded any malignancy and showed subcardial pouching of the dorsal gastric wall ([Fig. 2]). Oral contrast swallow ([Fig. 3]) and endoscopy confirmed the diagnosis of a gastric diverticulum with an aperture of 35 mm, filled with food remnants. Due to the clinical relevance of this benign finding, the patient was referred to general surgery. Using an endoscopic rendezvous technique, laparoscopic resection was carried out with an EchelonFlex60 Endopath Stapler (Ethicon Endo-Surgery, Cincinnati, Ohio, USA) under visual control from both sides of the diverticulum ([Fig. 4]). Histologic examination showed a full-thickness stomach specimen with slight chronic inflammation of otherwise normal gastric mucosa, indicative of a congenital diverticulum. Both the fetor and reflux symptoms ceased immediately after the surgery. A second contrast swallow on postoperative day 5 showed a patent suture and the patient was discharged thereafter.

Prospective, randomized trial comparing harmonic scalpel and electrocautery in breast surgery.

e12014 Background: The objective of this study was to compare the potential advantages of the harmonic scalpel with those of electrocautery for axillary lymph node dissection in breast surgery. Methods: A prospective randomized study of axillary lymph node dissection procedures performed between March 2011 and September 2012 was conducted. Primary breast cancer patients with axillary node-positive status (n = 25) were randomly assigned to the harmonic scalpel (group A, n = 13) or electrocautery (group B, n = 12) groups.The patients underwent breast-conservation surgery or mastectomy with a level I and II axillary dissection, which was performed by one surgeon. The time required for resection and the blood loss during the lymphadenectomy were recorded. The HARMONIC FOCUS (Ethicon Endo-Surgery, Inc.) was used as the ultrasonic scalpel. A low-pressure vacuum drain was placed in the axilla and removed when the drainage volume reduced to less than 50 ml over 24 hours. After the operations, the patients were assessed for the presence of seroma in an outpatient setting. Results: Resection timein group A was significantly shorter than that in group B (mean, 28.6 ± 5.1 vs. 40.3 ± 5.6 min; P = 0.0001). Similarly, blood loss in group A was significantly lower than that in group B (mean, 7.9 ± 5.3 vs. 22.9 ± 11.5 ml; P = 0.001). Duration of drain placement in group A was significantly lower than that in group B (mean, 3.5 ± 1.1 vs. 5.0 ± 0.9 days; P = 0.01), and the seroma rate in group A was lower than that in group B (23% vs. 66%; P = 0.04). Conclusions: For axillary lymph node dissection, the harmonic scalpel is more effective in terms of resection time, blood loss, duration of drain placement, and postoperative seroma formation.

Electrothermal bipolar vessel sealing system (LigaSure™) for hemostasis during thyroid surgery: a comprehensive review

Conventional hemostatic technologies utilized in thyroid surgery include clamp-and-tie, clips and monopolar and bipolar diathermy. Over the last decade, there has been a major shift towards utilizing newer hemostatic technologies, most notably the electrothermal bipolar vessel sealing systems (EBVS) and the Harmonic Scalpel® (Ethicon Endosurgery, OH, USA), for thyroid surgery. Since the first report of EBVS thyroidectomy in 2003, more than 50 studies have been published evaluating EBVS utilization for thyroid surgery. In addition to providing a historical perspective and exploring the principles of EBVS technology, this review aims to evaluate the current published data regarding EBVS utilization for thyroid surgery. In particular, a focus is given to LigaSure™ (Covidien, Dublin, Ireland) technology because it has been studied most thoroughly in the literature. This review will also evaluate studies comparing the EBVS with Harmonic Scalpel technology for thyroid surgery.

Sa1450 Safety and Risk Factors for Procedural Sedation in the 21st Century: a Review of Over 2 Million Patients From 2000-2011

Safety and Risk Factors for Procedural Sedation in the 21st Century: a Review of Over 2 Million Patients From 2000-2011 John J. Vargo*, Douglas O. Faigel, Paul Niklewski, James Martin, Jeffrey L. Williams, Jennifer L. Holub Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH; Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ; Ethicon Endo-Surgery, Cincinnati, OH; Department of Gastroenterology, Oregon Health and Science University, Portland, OR; Neuroscience, University of Cincinnati, Cincinnati, OH Background: The advent of propofol-mediated sedation and the use of anesthesia professionals (APanesthesiologist or nurse anesthetist) have changed the procedural sedation landscape over the past ten years. The identification of risk factors for serious adverse events during EGD and colonoscopy in this new landscape has not been well studied. Aim: To assess the prevalence and risk factors for serious interventions as related to procedural sedation. Design: Retrospective cohort study. A procedure specific multivariate logistic regression analysis was performed, with covariates including age, gender, ASA classification, sedationist, and procedure indications. Setting: Clinical Outcomes Research Initiative National Endoscopy Database, 2000-2011. Patients: Adults undergoing colonoscopy or EGD procedures in 84 academic, VA and community sites throughout the US. Main Outcome Measurement: The risk of serious intervention based on the use of hemostasis, CPR, hospital/ER admittance, sedation reversal, emergency surgery, stopped procedure, and blood transfusion. Results: 1,372,524 colonoscopy and 805,006 EGD patients were included with 70% seen in the community setting. The presence of an AP increased from 4.3% to 23.5% for colonoscopy and from 4.1% to 23.4% for EGD procedures during this 11 year period. Propofol use increased from 2.3% to 24.5% for colonoscopy and 1.8% to 21.5% for EGD. Fentanyl use increased (colonoscopy 27.1 to 65.5%, EGD 25.1 to 67.2%) and meperidine use decreased (colonoscopy 68.2 to 5.4%, EGD 60.2 to 5.4%). CPR remained stable across the 11 years at 0.005% for colonoscopy and 0.05% for EGD. Use of a reversal agent for colonoscopy decreased from 0.17% to 0.01% and from 0.20% to 0.02% for EGD. 18 deaths were reported for EGD (4 possibly due to sedation, bradycardia/hypoxemia). 8 deaths were reported for colonoscopy (1 possibly due to sedation, hypoxemia). The table shows older age, higher ASA classifications, narcotic administration, trainee involvement, certain non-screening indications, and presence of AP for EGD procedures are associated with increased risk of serious events. Limitations: The main outcome measurement assesses procedural interventions and is not limited to only interventions directly related to sedation. Fields pertaining to sedationist and procedure medications are not required in the CORI software, leading to some missing data. Conclusion: We identified sedation practice changes over this time period and risk factors for adverse outcomes related to procedural sedation. In this analysis of over 2.1 million patients across 11 years, it is clear that sedation during routine colonoscopy and EGD has an excellent safety profile for healthy patients when administered by endoscopists. Utilization of an anesthesia provider did not improve patient safety; in fact the endoscopist was safer for EGD procedures.

Optimum cystic duct closure: a comparative study using metallic clips, ENSEAL, and ENDOLOOP in swine

BackgroundMetal clips are commonly used to secure the cystic duct during cholecystectomy, although use of an ENDOLOOP (Ethicon Endo-Surgery, Blue Ash, OH) is often touted as a more secure closure when postoperative endoscopic retrograde cholangiopancreatography (ERCP) is anticipated. The objective of this study was to test the strength of 3 different cystic duct closure methods in a model simulating postoperative biliary insufflation. MethodsThe extrahepatic biliary system, including common bile duct, gallbladder, and cystic duct, was harvested en bloc from 22 swine postmortem. A cholecystectomy was performed and the cystic duct was secured using 1 of 3 randomly assigned methods: metallic clips (Ethicon Endo-Surgery), an ENDOLOOP (Ethicon Endo-Surgery), or an ENSEAL tissue sealing device (Ethicon Endo-Surgery). The common bile duct was cannulated with a pressure-monitoring system and insufflated with air. The burst pressures, location of rupture, and size of the common bile duct and cystic duct were recorded and compared. ResultsThere were 7 pigs each in the ENDOLOOP and ENSEAL groups and 8 in the metallic clip group, with no statistical significance between cystic and common bile duct size. Mean burst pressure was 432 mm Hg for metallic clips, 371 mm Hg for the ENDOLOOP, and 238 mm Hg for the ENSEAL device (P = .02). Post hoc analysis revealed clips to be statistically superior when compared with the ENSEAL (P= .01). There was no statistical difference between the ENDOLOOP and metal clips or between the ENDOLOOP and the ENSEAL. ConclusionsAll 3 closure methods successfully secured the cystic duct, with mean burst pressures exceeding 195 mm Hg. Metallic clips demonstrated the highest burst pressures and no cystic duct stump leaks. This study challenges the traditional dogma of additionally securing the cystic duct with an ENDOLOOP when postoperative biliary instrumentation is expected and also suggests that an adequately secure closure may be obtained with thermal sealing devices.

Anal mucosectomy for haemorrhoids: should we start to speak Chinese?

Circular stapled mucosectomy is the standard therapy for the treatment of symptomatic third-degree haemorrhoids and mucosal prolapse. Recently, new staplers made in China have entered the market offering an alternative to the PPH stapling devices. The aim of this prospective randomized study was to compare the safety and efficacy of these new devices. Fifty patients with symptomatic third-degree haemorrhoids were randomized to mucosectomy either by using stapler A (CPH32; Frankenman International Ltd, Hong Kong, China; n=25) or stapler B (PPH03; Ethicon Endo-Surgery, Spreitenbach, Switzerland; n=25). All procedures were performed by two experienced surgeons. After the stapler was fired by one surgeon, the other surgeon, who was blinded for stapler type, evaluated the stapler line. Postoperative outcome including pain, complications and patient satisfaction were analysed. Demographic and clinical features were no different between the groups. There was no significant difference regarding venous bleeding (P=0.55), but arterial bleeding was significantly more frequent when stapler B was used (P<0.001). This led to significantly more suture ligations (P=0.002). However, no differences regarding operation time (P=0.99), weight of the resected mucosa (P=0.81) and height of the stapler line (anterior, P=0.18; posterior, P=0.65) were detected. Postoperative pain scores (visual analogue scale) and patient satisfaction were no different either (P=0.91 and P=0.78, respectively). No recurrence or incontinence occurred during follow-up. CPH32 required significantly fewer sutures for bleeding control along the stapler line after circular mucosectomy. However, operation time, rate of postoperative complications and patient satisfaction were similar in both groups.

Comparison of two ultrasonic coagulating shears in sealing pulmonary vessels

Ultrasonic cutting and coagulating devices have been used successfully in thoracic applications such as pulmonary resection or artery harvesting, but few studies have evaluated their use in sealing pulmonary vessels. In this study we compared two commercially available devices, Harmonic Ace+ (HAR, Ethicon Endo-Surgery, Inc., Cincinnati OH, USA) and Sono- Surg (SS, Olympus America, Center Valley, PA, USA), in a canine preclinical model. There were three sections to the study: acute, survival, and ex vivo (burst pressure). Hemostasis of sealed pulmonary arteries and veins was assessed for the initial application and during a simu- lated hypertensive crisis, both immediately after vessel sealing and after a survival period of 30 days. Other intraoperative measures were also evaluated, including transection time, tissue sticking, tissue tags, and char on the seal. Histological evaluation was performed both after initial sealing and after the survival period. Burst pressure of sealed vessels was measured ex vivo. For both devices, hemostasis was excellent, including those measurements made under simulated hypertensive crisis. There were no differences in any of the intraoperative measures or thermal damage evaluated histologically. Wound healing was normal. The burst pressures for ex vivo vessels sealed by HAR (median 619.2 mmHg) were significantly higher than those of SS (350.3 mmHg, P = 0.022). Both devices displayed acceptable characteristics in sealing canine pulmonary arteries and veins. The only difference observed was that HAR produced burst pressures 76.8% greater than SS, which may lead to a lower percentage of failures in the region of physiological interest. Use of ultrasonic devices in thoracic applications provides a high rate of initial hemostasis, supraphysiological burst pressures, and durable seals that heal normally.

Safety and short‐term effectiveness of EEA stapler vs PPH stapler in the treatment of degree III haemorrhoids: prospective randomized controlled trial

Stapled haemorrhoidopexy has gained wide acceptance due to less postoperative pain although postoperative bleeding and prolapse recurrence are among the major drawbacks of this technique compared with the standard Milligan-Morgan hemorrhoidectomy. The aim was to investigate a new stapler device designed to overcome these side effects. In all, 135 patients (71 men, mean age 42 years) with degree III haemorrhoids were randomly allotted to stapled haemorrhoidopexy with PPH® staplers (Ethicon EndoSurgery) (63 patients) or with an EEA® stapler (Covidien) (72 patients) in four referral colorectal centres. The number of haemostatic overstitches apposed on the stapled suture, the area of the resected mucosa (in square centimetres) and any postoperative bleeding within 30 days were recorded. The mean area of the resected mucosa was significantly wider in EEA than PPH patients (35.75 ± 17.51 vs 28.05 ± 10.23 cm(2), P = 0.002). The median number of haemostatic stitches apposed in the EEA group was significantly lower than in the PPH groups (median value 1, vs 3, interquartile range 0-2, vs 2-5, P < 0.0001). Intraoperative haemostasis was better in the EEA group compared with the PPH01 and PPH03 groups. Postoperative bleeding occurred only in two PPH patients. Data suggest that the EEA stapler has better haemostatic properties than the PPH stapler and allows resection of a larger area of mucosal prolapse with potential benefits over the recurrence rate of haemorrhoid prolapse.

Haemothorax following bullectomy caused by a sharp edge of the Endoloop

A 22-year old man presented with a massive haemothorax 25 days after bullectomy for a spontaneous pneumothorax. Thoracoscopic surgery revealed ongoing bleeding from the chest wall caused by a sharp edge of the Endoloop Ligature (Ethicon Endo-Surgery) used to resect the remaining small part of the lung at the earlier staple bullectomy. The point where bleeding was occurring was clipped and covered using a collagen patch coated with human fibrinogen and thrombin. The protruding sharp edge of the Endoloop was excised together with the surrounding lung tissue, using a stapler. Although prevention of this type of complication is difficult, awareness of the potential problem may help in managing such extremely rare events.

Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial

Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes-including operative findings, complications, mortality, and results at pathological examination-are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100-400] vs 400 mL [200-700], p<0·0001); however, laparoscopic procedures took longer (240 min [184-300] vs 188 min [150-240]; p<0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0-3·0] vs 3·0 days [2·0-4·0]; p<0·0001) and hospital stay was shorter (8·0 days [6·0-13·0] vs 9·0 days [7·0-14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (<2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0-4·8] vs 3·0 cm [1·8-5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013. Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.

Bariatric Surgery Versus Intensive Medical Therapy in Obese Patients With Diabetes

Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medicaltherapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P = 0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P = 0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P = 0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (−29.4±9.0 kg and −25.1±8.5 kg, respectively) than in the medical-therapy group (−5.4±8.0 kg) (P<0.001 for both com parisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications. Conclusions In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.)

Ethicon Endo-Surgery Proximate and Transtar Staplers

Biomedical Safety & Standards 43(1):p 3, January 15, 2013. | DOI: 10.1097/01.BMSAS.0000425564.84419.f3

One-shot aortic anastomosis with an automatic stapling gun

We performed aortic arch replacement with a circular staple gun (Intraluminal Stapler System, ILS; Ethicon Endo-Surgery Inc, Somerville ,N J), an automatic anastomosis device used in gastrointestinal surgery. The features of the ILS are adjustable stapler height and controlled compressed tissue thickness, allowing uniform staple formation and providing a leak-free anastomosis and good hemostasis. The circular staple gun has been used in gastrointestinal operations since the 1980s, but its early use was controversial. Now that the device has been standardized, this first report of clinical use in aortic aneurysm surgery is pivotal and likely to change practice in cardiovascular surgery. CLINICAL SUMMARY

Stapled Hemorrhoidectomy; Results of a Prospective Clinical Trial in Saudi Arabia

This study was designed to evaluate the effectiveness of stapled hemorrhoidectomy (SH) in terms of cure of the symptoms and post-operative pain control. In this prospective clinical study, SH (Ethicon Endo-surgery, Cincinnati, OH) was performed for all patients with grade III and grade IV hemorrhoids, presenting to the surgical clinics of Ohud and Meeqat Hospitals Almadinah Almunawwarah Saudi Arabia. The results of SH were evaluated by a questionnaire focusing on the relief of symptoms, severity of post operative pain, and complications of SH. Thirty patients (21 males and 9 females); with a mean age of 39.6 years were recruited in this study. Twenty six (86%) patients had grade III and 4 (14%) presented with grade IV hemorrhoids. Perianal prolapse was the most frequent presentation reported in 23 (76%). Mean operating time was 21.7 minutes (range; 17-36 minutes) whereas mean hospital stay was 1.9 days. Post-operative pain was tolerable (non-persistent) in 28 (93%) cases whereas 2 (7%) experienced mild pain requiring additional analgesia. Urinary retention was the most common complication found in 5 (16%) patients. All patients were cured of the hemorrhoids Conclusion: SH is a safe, rapid, and convenient surgical remedy for grade III and grade IV hemorrhoids with low rate of complications, minimal postoepative pain, and early discharge from the hospital.