W. Scott Melvin

Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial

BackgroundNatural-orifice translumenal endoscopic surgery (NOTES) is a possible advancement for surgical interventions. We initiated a pilot study in humans to investigate feasibility and develop the techniques and technology necessary for NOTES. Reported herein is the first human clinical trial of NOTES, performing transoral transgastric diagnostic peritoneoscopy.MethodsPatients were scheduled to undergo diagnostic laparoscopic evaluation of a pancreatic mass. The findings of traditional laparoscopy were recorded by anatomical abdominal quadrant. A second surgeon, blinded to the laparoscopic findings, performed transgastric peritoneoscopy. Diagnostic findings between the two methods were compared and operative times and clinical course were recorded. Definitive care was based on findings at diagnostic laparoscopy.ResultsTen patients completed the protocol with an average age of 67.6 years. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic endoscopic peritoneoscopy. The average time of diagnostic laparoscopy was 12.3 minutes compared to 24.8 minutes for the transgastric route. Transgastric abdominal exploration corroborated the decision to proceed to open exploration made during traditional laparoscopic exploration in 9 of 10 patients. Peritoneal or liver biopsies were obtained in four patients by traditional laparoscopy and in one patient by the transgastric access route. Findings were confirmed by laparotomy in nine patients. Eight patients underwent pancreaticoduodenectomy and two underwent palliative gastrojejunostomy and/or hepaticojejunostomy.ConclusionsTransgastric diagnostic peritoneoscopy is safe and feasible. This study demonstrates the initial steps of NOTES in humans, providing a potential platform for incisionless surgery. Technical issues, including instrumentation, visualization, intra-abdominal manipulation, and gastric closure need further development.

Esophageal sphincter device for gastroesophageal reflux disease.

BACKGROUND Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported. RESULTS The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed. CONCLUSIONS In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.).

Computer-Enhanced vs. Standard Laparoscopic Antireflux Surgery☆

Computer-assisted telesurgical devices have recently been approved in the United States for general surgery. To determine the safety and efficacy of these procedures, we performed a prospective trial of computer-enhanced “robotic” fundoplication compared to standard laparoscopic control procedures. Consecutive patients undergoing surgical treatment for gastroesophageal reflux were included. The operating surgeon worked at a console using a three-dimensional image and manipulated hand controls. Operative times, complications, and length of hospital stay were recorded. A standardized questionnaire was administered to evaluate symptoms. Twenty patients were entered into each group. There were no differences in age, preoperative weight, or sex. Operative times were significantly longer in the robot group (97 vs. 141 minutes). There were no complications and most patients went home the first postoperative day. At follow-up, symptoms were similar in both groups; however, there was a significant difference in the number of patients taking antisecretory medication—none in the robotic group but six in the laparoscopic group reported regular use. Computer-assisted laparoscopic antireflux surgery is safe. However, operative times are longer, with little difference in outcomes. At the current level of technology and experience, robotic antireflux surgery appears to offer little advantage over standard laparoscopic approaches.

Laparoscopic skills enhancement

BACKGROUND Laparoscopy requires a unique subset of surgical skills that, for the inexperienced, can significantly delay the development of basic operative skills. We hypothesized that learning laparoscopic suturing and knot tying would improve laparoscopic skills. METHODS A laparoscopic training seminar for junior surgical residents was established to test this hypothesis. Emphasis was placed on laparoscopic knot tying and suturing. Skills were assessed at the beginning and the end of the course. RESULTS All residents showed significant improvement. Dominant and nondominant hand skills improved by 30.2% and 26.9%, respectively. Two-handed skills improved by 58.6% and 30.1%. Overall scores improved by 28.9%. CONCLUSIONS A structured laparoscopic skills course stressing knot tying and suturing is an effective way to develop dexterity and significantly improve the performance of laparoscopic tasks. These improvements can be accomplished in a cost-effective curriculum that should enhance the surgical education of residents and speed the acquisition of competent operative skills.

Barbed Suture for Gastrointestinal Closure: A Randomized Control Trial

In an effort to make laparoscopic suturing more efficient, the V-Loc advanced wound closure device (Covidien, Mansfield, MA) has been produced. This device is a self-anchoring barbed suture that obviates the need for knot tying. The goal of this initial feasibility study was to investigate the use of the barbed suture in gastrointestinal enterotomy closure. A randomized study of 12 pigs comparing enterotomy closure with barbed versus a nonbarbed suture of similar tensile strength was performed. To this end, 25 mm enterotomies were made in the stomach (1 control, 1 treatment), jejunum (2 controls, 2 treatments), and descending colon (1 control, 1 treatment). Animals were killed at 3, 7, and 14 days postoperatively (4 each group) and their gastrointestinal tracts harvested; 6 of the 8 enterotomies from each pig underwent burst strength testing. The remaining 2 were fixed in formalin and sent for histological examination. All 12 pigs survived until they were killed without any major complications. Enterotomy closure with barbed suture revealed adhesion scores, burst strength pressures, and histology scores that were similar to those for the control. Jejunal closures resulted in 6 failures at 7 days (3 control, 3 barbed) and 4 failures at 14 days (2 control, 2 barbed). The barbed suture significantly reduced suturing time in the stomach, jejunum, and colon. The V-Loc wound closure device appears to offer comparable gastrointestinal closure to 3-0 Maxon while being significantly faster. Further studies with V-Loc are required to assess its use in laparoscopic surgery.

Transgastric instrumentation and bacterial contamination of the peritoneal cavity

IntroductionNatural orifice transluminal endoscopic surgery (NOTES) is a rapidly evolving technique providing access to the peritoneum utilizing an endoscope via a natural orifice. One of the most significant requirements of this technique is the need to minimize the risk of clinically significant peritoneal contamination. We report the bacterial load and contamination of the peritoneal cavity in patients requiring a gastrotomy Roux-en-Y gastric bypass (LSRYGB).MethodsWe prospectively studied 50 patients undergoing a gastrotomy with creation of a gastrojejunostomy during LSRYGB. We recorded the patient’s proton-pump inhibitor (PPI) utilization preoperatively and sampled gastric contents without lavage. We also sampled peritoneal fluid prior to and after gastrotomy, noting the length of time the gastrotomy was open to the peritoneum. Each of the three samples was sent for bacterial colony counts, and culture with identification of species.ResultsFifty patients underwent LSRYGB with a mean operative time of 93 min. The gastrotomy was open to the peritoneal cavity for an average of 18 min. Seventeen of 50 patients were on PPIs preoperatively, resulting in a significant difference in postgastrostomy peritoneal bacterial counts. The average number of colony-forming units (CFU) of the gastric aspirate was 22,303 CFU/ml. Peritoneal aspirates obtained for examination prior to creation of a gastrotomy showed no CFUs in 44 of 50 patients. Peritoneal sampling after gastrotomy showed contamination of the abdomen with an average of 1102 CFU/ml. There was no correlation between the bacterial load in the stomach and peritoneal load after gastrotomy. No infectious complications or leaks developed. One complication of rhabdomyolysis in a patient with no peritoneal bacterial contamination developed.ConclusionsTransgastric instrumentation does contaminate the abdominal cavity but pathogens are clinically insignificant due to species or bacterial load. Patients on PPIs do have an increased bacterial load in the gastric aspirate, with no clinical significant infection.

Robotic and laparoscopic pancreaticoduodenectomy: A hybrid approach

Objectives: Minimally invasive surgery is beneficial for complex operations; robotics may improve performance in these procedures; however, robotic pancreaticoduodenectomy (PD) has been plagued by long operative times. We describe a small series (n = 5) of patients who underwent a hybrid PD for treatment of obstructive jaundice and pancreatic mass. Methods: After diagnostic laparoscopy, the gallbladder was retracted cephalad and the porta hepatis was dissected. The lesser sac was opened to expose the superior mesenteric vein below the pancreas. Once the vein was cleared, the bile duct, stomach, pancreas, and jejunum were transected. After the uncinate process was cleared, the specimen was removed. The da Vinci S Surgical Robotic System was docked to perform a mucosa-to-mucosa pancreaticojejunostomy and an end-to-side choledochojejunostomy. A stapled gastrojejunostomy and drain placement completed the operation. Results: Five patients underwent hybrid PD between May 2006 and June 2007. All patients had a history of pancreatitis and presented with obstructive jaundice and a pancreatic mass. The operations were completed with 5 ports. The mean operative time was 7 hours. The mean hospital stay was 9.6 days. At 6 months after the operation, all patients were disease-free. Conclusions: Complex procedures such as PD can be accomplished with minimally invasive surgical techniques using robotic instrumentation.

Pancreatic Resection in the Octogenarian: A Safe Option for Pancreatic Malignancy

BACKGROUND The incidence of pancreatic cancer is age related; patients older than the age of 65 represent 60% of all cases. We assessed our institutions experience and outcomes with pancreatic resection for malignancy in patients in their ninth decade. STUDY DESIGN We reviewed records of patients undergoing pancreatic resection for malignancy at our institution between 1990 and 2007. Demographics, laboratory, treatment, and outcomes data were gathered. Comparisons were made between patients older and younger than the age of 80. Survival was analyzed using the Kaplan-Meier method and comparisons between groups were performed using the log-rank test. Regression methods were used to evaluate predictors of outcomes. RESULTS There were 517 pancreatic resections for cancer reviewed. Of these, 27 patients were 80 years or older (age range 80 to 91 years), compared with 490 patients less than 80 (range 20 to 79 years). The distribution of clinical characteristics was similar between the 2 groups. The majority of patients undergoing pancreatic resection harbored a mass in the head of the pancreas, so the most common procedure was pancreaticoduodenectomy (n = 398, 78%). There were no significant differences in complication rates for younger and older groups (59% vs 52%, respectively, p = 0.4), median length of stay (11 vs 12 days, p = 0.33), or perioperative mortality rates (3.7% vs 3.7%, p = 1.0). Overall survival between the 2 groups was similar (21.9 vs 33.3 months, p = 0.18). CONCLUSIONS Pancreatectomy for malignancy is a safe option for the elderly. Patients older than age 80 achieved similar results, with similar rates of perioperative complications and mortality. Pancreatectomy for cancer offers a similar survival benefit in both groups.

Natural Orifice Translumenal Endoscopic Surgery

This article provides an overview of the currently available animal data on natural orifice translumenal endoscopic surgery (NOTES) on the topics of translumenal access and closure, iatrogenic intraperitoneal complications, especially infection and overinsufflation, spatial orientation, and the development of enabling technologies. Human trials to date are also reviewed and discussed.

Computer-assisted robotic heller myotomy: initial case report.

PURPOSE Our objective was to determine the efficacy of computer-assisted robotic laparoscopic Heller myotomy. METHODS A 76-year-old woman with a significant history of achalasia was evaluated for laparoscopic Heller myotomy. The daVinci surgical system was used throughout the procedure. RESULTS Computer assistance allowed scaling of hand motions from a range of 2:1 to 5:1. Successful dissection of the esophageal musculature was accomplished, and a Toupet-type fundoplication was performed. The patient was discharged from the hospital the day after surgery with five port incisions, each <1 cm. CONCLUSIONS Telemanipulator computer-assisted surgical devices may have applications in procedures that require advanced and finely tuned motions, such as Heller myotomy. The benefits of extra magnification and three-dimensional imaging can help prevent esophageal perforation and identify residual circular muscle fibers.