Shlomo Lelcuk

A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery

BACKGROUND This randomized, double-arm trial was designed to study the benefit of a novel device (MarginProbe, Dune Medical Devices, Caesarea, Israel) in intraoperative margin assessment for breast-conserving surgery (BCS) and the associated reduction in reoperations. METHODS In the device group, the probe was applied to the lumpectomy specimen and additional tissue was excised according to device readings. Study arms were compared by reoperation rates and by correct surgical reaction confirmed by histology. RESULTS Three hundred patients were enrolled. Device use was associated with improved correct surgical reaction, defined as additional re-excision in all histologically detected positive margins, with tumor within 1 mm of inked margin. The repeat lumpectomy rate was significantly reduced by 56% in the device arm: 5.6% versus 12.7% in the control arm. There were no differences in excised tissue volume or cosmetic outcome. CONCLUSIONS Intraoperative use of the MarginProbe for positive margin detection is safe and effective in BCS and decreases the rate of repeat operations.

Structured Triacylglycerol Emulsion, Containing Both Medium- and Long-Chain Fatty Acids, in Long-Term Home Parenteral Nutrition: A Double-Blind Randomized Cross-Over Study

Structured lipid emulsion, an innovative approach in which both medium-chain and long-chain fatty acids are esterified to the same glycerol backbone, has been recently shown to be a safe and efficient way of providing energy to patients requiring parenteral nutrition. As yet, no assessment has been made of its safety and effect on liver functions during long-term treatment. Twenty-two home parenteral nutrition patients with Crohns disease or short bowel syndrome were enrolled in a double-blind randomized, cross-over study. Twenty patients who completed the study were treated for 4 wk with a structured lipid emulsion and for 4 wk with long-chain triacylglycerol emulsion. Determined every 1 or 2 wk were blood pressure, body weight, respiratory rate, blood count, liver functions, albumin, transferrin, plasma lipids, free fatty acids (FFAs), and, at the end of each treatment period (weeks 4 and 8), plasma dicarboxylic acids and 3-OH-fatty acids. No differences were observed between the groups or within the groups between the two treatments with respect to either clinical safety and adverse event occurrence or laboratory assessments. Plasma dicarboxylic acids and 3-OH-fatty acids were similar and within normal range. No alteration of liver function occurred in any of the patients treated with the structured lipid emulsion, whereas two of the patients receiving long-chain triaclyglycerol emulsion developed abnormal liver function, which resolved after switching to the structured lipid emulsion. In conclusion, structured triacylyglycerols containing both medium- and long-chain fatty acids appear to be safe and well tolerated on a long-term basis in patients on home parenteral nutrition, and it may be associated with possible reduction in liver dysfunction.

Diagnostic Performance of a Novel Device for Real-Time Margin Assessment in Lumpectomy Specimens

BACKGROUND Margin status in breast lumpectomy procedures is a prognostic factor for local recurrence and the need to obtain clear margins is often a cause for repeated surgical procedures. A recently developed device for real-time intraoperative margin assessment (MarginProbe; Dune Medical Devices, Caesarea, Israel), was clinically tested. The work presented here looks at the diagnostic performance of the device. METHODS The device was applied to freshly excised lumpectomy and mastectomy specimens at specific tissue measurement sites. These measurement sites were accurately marked, cut out, and sent for histopathologic analysis. Device readings (positive or negative) were compared with histology findings (namely malignant, containing any microscopically detected tumor, or nonmalignant) on a per measurement site basis. The sensitivity and specificity of the device was computed for the full dataset and for additional relevant subgroups. RESULTS A total of 869 tissue measurement sites were obtained from 76 patients, 753 were analyzed, of which 165 were cancerous and 588 were nonmalignant. Device performance on relatively homogeneous sites was: sensitivity 1.00 (95% CI: 0.85-1), specificity 0.87 (95% CI: 0.83-0.90). Performance for the full dataset was: sensitivity 0.70 (95% CI: 0.63-0.77), specificity 0.70 (95% CI: 0.67-0.74). Device sensitivity was estimated to change from 56% to 97% as the cancer feature size increased from 0.7 mm to 6.6 mm. Detection rate of samples containing pure DCIS clusters was not different from rates of samples containing IDC. CONCLUSIONS The device has high sensitivity and specificity in distinguishing between normal and cancer tissue even down to small cancer features.

Laparoscopic surgery of the gastroesophageal junction.

Incompetence of the lower esophageal sphincter mechanism leads to gastroesophageal reflux (GER), which is the most common indication for surgery of the gastroesophageal junction. Evaluation, diagnosis, and the modern surgical treatment of GER are discussed. Evaluation of patients with severe heartburn include upper endoscopy to evaluate the general condition of the esophagus, stomach, and duodenum; an upper gastrointestinal contrast study for a complete anatomic view of the esophagus and stomach; esophageal manometry to evaluate the function of the esophagus; 24-hour pH monitoring to determine esophageal acid exposure; and a gastric emptying study selectively to determine the presence of a motility disorder. These studies most often prove the diagnosis of gastroesophageal reflux, hiatal hernia, Barretts esophagus, peptic esophageal stricture, paraesophageal hernia, or achalasia. The laparoscopic approach to treatments for these include Nissen fundoplication, Toupet fundoplication, Collis gastroplasty with fundoplication, modified Heller myotomy, esophageal diverticulectomy, and revisional operations. These procedures are described in detail. The results of these operations indicate that they are safe and effective and should be considered the new gold standard for correction of gastroesophageal pathology. Laparoscopic surgery has revolutionized many procedures traditionally performed through a laparotomy. Although they are technically more difficult and require a significant amount of time and practice for the surgeon to become proficient, it is becoming apparent that for functional surgery of the gastroesophageal junction laparoscopy is the access of choice.

Phytobezoar: A Rare Cause of Intestinal Obstruction

Phytobezoar is a well-known although uncommon cause of mechanical alimentary tract obstruction, mainly in patients who have undergone previous gastric operation. Between January 1988 and March 1995, we operated on 14 patients with gastrointestinal obstruction due to phytobezoar. Eleven patients (78.6%) had undergone previous gastric operation and in all of them the diagnosis was made at the time of surgery. All admissions were during winter: supposedly because of the seasonal increase in intake of citrus fruits and persimmons. During the 7-year study period, we observed an unexpected increase in the incidence of this disorder. During the first 4 years we treated 2 patients (14.3%), an average of 0.5 patients a year, whereas during the last 3 years we operated on 12 patients (87.7%), an average of 4 patients a year. The recent increase in small-bowel obstruction secondary to phytobezoars may at least in part be explained by a major immigration wave from the former USSR. These immigrants have become exposed to an abundance of cheap fruits such as citrus and persimmons that were not available in their home country. The large consumption and the failure of information regarding the risks of consuming these fruits in association with previous gastric surgery may have played a major role in the recent increase of the incidence. Since phytobezoars may play increasingly an important role in the future due to the ingestion of great quantities of different fruits containing great amounts of cellulose, these findings call for restriction of citrus fruit and persimmons in patients who have undergone gastric surgery.

A nickel–titanium memory-shape device for colonic anastomosis in laparoscopic surgery

BackgroundMinimally invasive surgery is used increasingly for colonic resection. With this procedure, the involved colon is dissected laparoscopically and exteriorized through a small incision, and the segment containing the tumor is resected. The anastomosis is performed extraperitoneally either by hand suture or with a stapler. This study was designed to evaluate the feasibility of using a memory-shape compression anastomosis clip (CAC) to perform laparoscopically assisted colonic anastomosis. The study was prompted by the authors’ successful experience with the CAC in an animal model and in 10 patients with diverse colonic cancers.MethodsThe sample consisted of 10 patients who underwent laparoscopic colonic surgery at the authors’ center. The anastomosis was performed with the CAC for five patients and with a stapler for five patients. To perform anastomosis with the CAC, the two edges of the resected colon are aligned. Two 5-mm incisions are made near the edges, through which the CAC, after cooling in ice water, is introduced in an open position using a special applier. In response to body temperature, the clip resumes its original (closed) position, thereby clamping the two bowel loops together. At the same time, the small scalpel incorporated in the applier makes a small incision through the clamped walls for the passage of gas and feces, and the clip is released into the intestine. The two 5-mm incisions are sutured. The clip is expelled with the stool within 5 to 7 days, creating a perfect uniform anastomosis.ResultsNeither group had complications, except one patient from the control group who experienced a small bowel obstruction attributable to a wound suture problem, which required laparotomy. His recovery was uneventful.ConclusionsThe use of the CAC for colonic laparoscopic surgery is simple and very efficient, shortening operation time. It creates a uniform anastomosis, approximating the no-touch concept in surgery, and may prevent infection. It also is lower in cost than the stapler.

Laparoscopic extraperitoneal inguinal hernia repair with spinal anesthesia and nitrous oxide insufflation

AbstractBackground: Laparoscopic repair of inguinal hernia is traditionally performed under general anesthesia mainly because of the adverse effects that carbon dioxide pneumoperitoneum has on awake patients. Since a mandatory use of general anesthesia for all hernia repairs is questionable, the feasibility of laparoscopic extraperitoneal herniorraphy using spinal anesthesia combined with nitrous oxide insufflation was investigated. Methods: Over a 4-month period, February to May 1998, we performed 35 consecutive total extraperitoneal inguinal hernia procedures (24 unilateral, 11 bilateral) using spinal anesthesia and nitrous oxide extraperitoneal gas. Data on operative findings, self-reported operative and postoperative pain and discomfort (visual analog pain scale), procedure-related hemodynamics, and complications were collected prospectively. Results: All 35 procedures were completed laparoscopically without the need to convert to general anesthesia. Mean operative time was 39 ± 7 min for unilateral hernia and 65 ± 10 min for bilateral hernia. Incidental peritoneal tears occurred in 22 patients (63%) resulting in nitrous oxide pneumoperitoneum, which was well tolerated. The patients remained hemodynamically stable throughout the procedure, and operative conditions and visibility were excellent. Complications at a mean of 4 months after the procedure included seven uninfected seromas (20%), three patients with transient testicular pain, and one (3%) recurrence. Conclusions: Laparoscopic total extraperitoneal hernia repair can be safely and comfortably performed using spinal anesthesia with extraperitoneal nitrous oxide insufflation gas. This method provides a good alternative to general anesthesia.

Laparoscopic Gastric Banding with Lap-Band® for Morbid Obesity: Two-step Technique may Improve Outcome

Background: Laparoscopic placement of an adjustable gastric band is an attractive alternative for patients who can benefit from a restrictive bariatric procedure. Creation of the retrogastric tunnel (RGT) may,however, be a considerable challenge early in the surgeons learning curve. Recent reports described up to 10% band slippage and occasional gastric perforation associated with RGT. The twostep (TS) technique involves a crural dissection towards the angle of His through a gastrohepatic ligament approach. It facilitates passage of the bands tubing posteriorly with no wide posterior gastric wall dissection. Patients and Methods: Prospective data were registered for the 109 patients (92 females, 17 males) who underwent laparoscopic adjustable gastric banding from December 1998 to May 2000. In 11 patients the standard RGT approach was used, and in 98, the TS technique.The two groups were demographically similar. Mean age was 37 years (18-59); mean preoperative weight was 120 kg (90-165). Results: All procedures were completed laparoscopically.The mean operative time was 59 minutes (31-150) and the mean hospital stay 1.2 days (1-5). Complications in the TS group were gastric wall hematoma in one patient, 3 days of intubation post-operatively in one patient, damage to a band demonstrated in a postoperative contrast study in one patient, and a port-site hernia in one patient. There was no band slippage in theTS group. Among the 11 patients undergoing RGT, there was band slippage in three (27%), immediately postoperatively in one and after 3 and 11 months in the other two. In a mean follow-up of 7 months (1-18), similar weight loss was found in both groups.The mean BMI decreased from 44 kg/m2 (36-61) preoperatively to 40, 38, 36, 34 kg/m2 at 1, 3, 6 and 9 months respectively. 52 patients required band adjustment; of these, 12 required two adjustments. Conclusion: Our experience with both the RGT andTS techniques indicates that the latter may offer better results, particularly in the early experience period. It is recommended that in their initial experience with the adjustable band, surgeons should become familiar with this approach.

Compression gastrointestinal anastomosis

The creation of anastomoses between various parts of the GI tract is a major task in the daily practice of oncological, reconstructive and transplant surgery. The most widely used anastomosing techniques today involve the use of sutures or metal titanium staples. Both techniques involve foreign material penetrating the tissue and evoking localized inflammatory response, tissue injury and breaking of mucosal barriers that may facilitate bacterial growth within the anastomotic line, increasing the propensity to anastomotic-related morbidity. Different types of compression devices were successfully used clinically in the past. The history and evolving characteristics of this technology is reviewed. Nitinol-based solutions for the creation of compression anastomosis are evaluated as a possible potential for revolutionary impact on the current surgical methods and anastomosing technology in the alimentary tract and beyond.

Gangrene of the lower limbs in diabetic patients: A malignant complication

Diabetic foot lesions are a common medical problem with major socioeconomic impact. Gangrene is usually a late and sometimes fatal complication. A series of 118 diabetic patients who underwent amputation of the lower limb at our institution over a 10 year period has been presented. Forty-two patients underwent amputation of the toes or part of the foot, 48 underwent below-knee amputation, and 18 underwent above-knee amputation. In 24 (20.3 percent), the necrotic process advanced postoperatively and necessitated additional amputation. The average hospital stay was 33.6 days. Twenty-eight patients (23.7 percent) died during the postoperative period, and the main cause of death was sepsis. Patients who presented with extensive gangrene had a higher mortality rate. There was no correlation between mortality and the duration of conservative treatment, number of repeated operations, the treatment of diabetes before hospitalization, onset of symptoms, or status of the peripheral pulses. The solution to the problem is early and vigorous preventive treatment. This could be accomplished through highly specialized clinics within the community.