Innovation, disruption, and the perils of success. SAGES Presidential Address, 14 April 2005.
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Biomedical subjects
Publications and source records attributed to David W Rattner.
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BACKGROUND: Transgastric cholecystectomy is a natural orifice transluminal endoscopic surgery (NOTES) procedure that has been reported in 2 nonsurvival studies. Both studies detail substantial technical limitations, with only a 33% success rate when limited to 1 gastric incision site, despite the use of a multichannel locking endoscope. OBJECTIVE: The aim of this study was to evaluate the feasibility and technical limitations of transcolonic cholecystectomy in a survival model. DESIGN: Animal feasibility study. INTERVENTIONS: Five pigs, under general anesthesia, were prepared with tap-water enemas, a peranal antibiotic lavage, and a Betadine rinse. A dual-channel endoscope was advanced into the peritoneum through an anterior, transcolonic incision 15 to 20 cm from the anus. After cystic duct and artery ligation, dissection of the gallbladder was achieved by using grasping and cutting instruments. After removing the gallbladder, the colonic incision was closed by using Endoloops and/or endoclips. The animals lived for 2 weeks after the procedure, then they were euthanized, and a necropsy was performed. RESULTS: All 5 gallbladders were successfully resected. Four of the 5 animals flourished in the postoperative period, with appropriate weight gain. In 1 animal, complete closure of the colonic incision was not possible, and it was euthanized at 48 hours for suspected peritonitis. CONCLUSIONS: This study reports the first transcolonic organ resection and demonstrates the first successful NOTES cholecystectomy in a survival model. The transcolonic approach provided improved endoscope stability and biliary exposure compared with the transgastric route, and complete incision closure appeared critical for procedural success.
BACKGROUND: Many surgeons believe that long turnover times between cases are a major impediment to their productivity. We hypothesized that redesigning the operating room (OR) and perioperative-staffing system to take advantage of parallel processing would improve throughput and lower the cost of care. METHODS: A state of the art high tech OR suite equipped with augmented data collection systems served as a living laboratory to evaluate both new devices and perioperative systems of care. The OR suite and all the experimental studies carried out in this setting were designated as the OR of the Future Project (ORF). Before constructing the ORF, modeling studies were conducted to inform the architectural and staffing design and estimate their benefit. In phase I a small prospective trial tested the main hypothesized benefits of the ORF: reduced patient intra-operative flow-time, wait-time and operative procedure time. In phase II a larger retrospective study was conducted to explore factors influencing these effects. A modified process costing method was used to estimate costs based on nationally derived data. Cost-effectiveness was evaluated using standard methods. RESULTS: There were 385 cases matched by surgeon and procedure type in the retrospective dataset (182 ORF, 193 standard operating room [SOR]). The median Wait Time (12.5 m ORF vs 23.8 m SOR), Operative Procedure Time (56.1 m ORF vs 70.5 m SOR), Emergence Time (10.9 m ORF vs 14.5 m SOR) and Total Patient OR Flowtime (79.5 m ORF vs 108.9 m SOR) were all shorter in the ORF (P < .05 for all comparisons). The median cost/patient was $3,165 in the ORF (interquartile range, $1,978 to $4,426) versus $2,645 in SORs (interquartile range, $1,823 to $3,908) (P = ns). The potential change in patient throughput for the ORF was 2 additional patients/day. This improved throughput was primarily attributable to a marked reduction in the non-operative time (ie, those activities commonly accounting for "turnover time") rather than facilitation of faster operations. The incremental cost-effectiveness ratio of ORF was $260 (interquartile range, $180 to $283). CONCLUSION: The redesigned perioperative system improves patient flow, allowing more patients to be treated per day. Cost-effectiveness analysis suggests that the additional costs incurred by higher staffing ratios in an ORF environment are likely to be offset by increases in productivity. The benefits of this system are realized when performing multiple, short-to-medium duration procedures (eg, <120 m).
BACKGROUND: Immunotherapy has been proposed as a novel treatment for pancreatic cancer. However, patients with pancreatic cancer have been observed to have depressed immune responses, suggesting that immunotherapy might have limited utility in this group of patients. We sought to determine whether patients undergoing postresection or primary medical treatment for pancreatic adenocarcinoma were immunocompetent. METHODS: We enrolled patients with pancreatic adenocarcinoma scheduled for postresection or primary chemotherapy and/or radiation therapy. At the initiation of therapy, the patients had an anergy panel placed and baseline blood work performed. During the first week of treatment, patients received tetanus toxoid (TT), Haemophilus influenzae and Pneumococcus vaccines. Twelve weeks after vaccine administration, IgG titers against the 3 administered vaccines were done, and lymphocyte proliferation assays in response to TT were performed. RESULTS: Eighteen patients were originally enrolled, and 14 patients completed all elements of the trial. Anergy panel responses were obtained for 15 patients who comprised the final study group; both pre- and postvaccination data were available for 14 patients. Nine of 15 patients demonstrated at least a 10-mm induration in response to mumps or Candida antigen (60% response rate, 95% confidence interval (CI) 32-84%). Thirteen of 14 patients demonstrated a > or =3-fold increase in IgG against one or more vaccines (93% response rate, 95% CI 66-100%). Nine of 14 patients (64% response rate, 95% CI 35-87%) demonstrated at least a 3-fold rise of lymphocyte proliferation against TT. CONCLUSIONS: Patients with pancreatic cancer were capable of mounting effective cellular and humoral responses to standard vaccines. These data suggest that immunotherapy for pancreatic cancer may be feasible and merits further investigation.
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BACKGROUND: The Massachusetts General Hospital (MGH) Operating Room of the Future (ORF) project is a test site for evaluating new surgical technologies and processes. Here we evaluate the effect on staff satisfaction and burnout of introducing a set of new technologies. METHODS: Staff satisfaction and burnout were measured via sequential surveys based on the Maslach Burnout Inventory during the introduction of a new technology system. Functional behavior of the OR was measured in terms of flow time (time to transit the OR) and wait time (time to access the OR). These data were gathered using time-motion analysis methods. RESULTS: Significant functional improvements were found in the ORF (more than 35% reduction in flow time and wait time, P < .05). During the same period, more exposure to the ORF resulted in greater sense of personal accomplishment among surgeons, a worse sense of personal accomplishment among nurses, more emotional exhaustion among surgeons, and less emotional exhaustion among nurses. However, the responses for emotional exhaustion were reversed the greater the time from exposure to the ORF. Staff with 6 to 10 years' experience were at highest risk for burnout across all categories. General surgeons experienced more emotional exhaustion than other physicians. CONCLUSIONS: Tracking the response of all users and identifying groups at high risk for burnout when exposed to new systems should be a central part of any new technology project.
Gastrointestinal stromal tumors (GIST) of the stomach are being recognized with increasing frequency. The diagnosis is usually made on the basis of appearance on computed tomography (CT) and excision is recommended for GIST larger than 5 cm. We report a 39-year-old woman referred for resection of a presumed GIST of the gastric fundus diagnosed by CT scan and upper gastrointestinal (UGI) series. A laparoscopic resection was performed, but upon pathologic examination the mass proved to be a bronchogenic duplication cyst of the stomach. Bronchogenic and esophageal duplication cysts usually arise in the chest or mediastinum. On rare occasions bronchogenic cysts may lose their connection to the tracheobronchial tree and migrate to a subcutaneous position in the neck or descend into the retroperitoneum. The importance of this case is that it demonstrates a rare yet essential component to the differential diagnosis of lesions of the stomach.
OBJECTIVE: This review addresses the historical evolution of hiatal hernia (HH) repair and reports in a chronological fashion the major milestones in HH surgery before the laparoscopic era. METHODS: The medical literature and the collections of the History of Medicine Division of the National Library of Medicine were searched. Secondary references from all sources were studied. The senior author's experience and personal communications are also reported. RESULTS: The first report of HH was published in 1853 by Bowditch. Rokitansky in 1855 demonstrated that esophagitis was due to gastroesophageal reflux, and Hirsch in 1900 diagnosed an HH using x-rays. Eppinger diagnosed an HH in a live patient, and Friedenwald and Feldman related the symptoms to the presence of an HH. In 1926, Akerlund proposed the term hiatus hernia and classified HH into the 3 types that we use today. The first elective surgical repair was reported in 1919 by Soresi. The physiologic link between HH and gastroesophageal reflux was made at the second half of the 20 century by Allison and Barrett. In the midst of a physiologic revolution, Nissen and Belsey developed their famous operations. In 1957, Collis published his innovative operation. Thal described his technique in 1965, and in 1967, Hill published his procedure. Many modifications of these procedures were published by Pearson and Henderson, Orringer and Sloan, Rossetti, Dor, and Toupet. Donahue and Demeester significantly improved Nissen's operation, and they were the first to truly understand its physiologic mechanism. CONCLUSION: Hiatal hernia surgery has evolved from anatomic repair to physiological restoration.
OBJECTIVE: To define the natural history and optimal management of serous cystadenoma of the pancreas. SUMMARY BACKGROUND DATA: Serous cystadenoma of the pancreas is the most common benign pancreatic neoplasm. Diagnostic criteria, potential for growth or malignancy, and outcomes are not well defined. As a result, management for patients with serous cystadenomas varies widely in current practice. METHODS: A total of 106 patients presenting with serous cystadenoma of the pancreas from 1976-2004 were identified. Hospital records were evaluated for patient and tumor characteristics, diagnostic workup, treatment, and outcome. Twenty-four patients with serial radiographic imaging were identified, and tumor growth curves calculated. RESULTS: Mean age at presentation was 61.5 years and 75% of patients were female. The most common symptoms were abdominal pain (25%), fullness/mass (10%), and jaundice (7%); 47% were asymptomatic. Mean tumor diameter was 4.9 +/- 3.1 cm, which did not vary by location. Tumors <4 cm were less likely to be symptomatic than were tumors > or =4 cm (22% vs. 72%, P < 0.001). The median growth rate in the patients who had serial radiography was 0.60 cm/y. For tumors <4 cm at presentation (n = 15), the rate was 0.12 cm/y, whereas for tumors > or =4 cm (n = 9), the rate was 1.98 cm/y (P = 0.0002). Overall, 86 patients underwent surgery, with one perioperative death. CONCLUSIONS: Large (>4 cm) serous cystadenomas are more likely to be symptomatic. Although the median growth rate for this neoplasm is only 0.6 cm/y, it is significantly greater in large tumors. Whereas expectant management is reasonable in small asymptomatic tumors, we recommend resection for large serous cystadenomas regardless of the presence or absence of symptoms.
Although there have been significant advances in the development of virtual-reality-based surgical simulations, there remain fundamental questions concerning the fidelity required for effective surgical training. A dual-station experimental platform was built for the purpose of investigating these fidelity requirements. Analogous laparoscopic surgical tasks were implemented on a virtual station and a real station, with the virtual station modeling the real environment with various degrees of fidelity. After measuring the subjects' initial performance on the real station, different groups of subjects were trained on the virtual station under a variety of conditions and finally tested on the real station. Experiments involved bimanual pushing and cutting tasks on a nonlinear elastic object. The results showed that force feedback results in significantly improved training transfer as compared to training without force feedback. The training effectiveness of a linear approximation model was approximately the same as that of a more accurate nonlinear model.
The pylorus-preserving pancreaticoduodenectomy (PPPD) is an alternative to the standard Whipple resection in the treatment of chronic pancreatitis. The operation is safe and can be performed with a low mortality rate. The most common early complication is delayed gastric emptying, which occurs in 25% to 30% of patients, and generally results in longer hospital stays than the standard Whipple procedure. Follow-up studies show that both operations are equally effective in relieving pain in approximately 75% of selected patients. In the long term, the PPPD successfully preserves physiologic gastric emptying, but at the cost of a higher marginal ulceration rate. The purported nutritional advantages of the PPPD over the classic Whipple resection have not been clearly established. At present, the PPPD is the procedure of choice for patients with chronic pancreatitis requiring panceraticoduodenectomy. Based on available information, this recommendation appears to arise form the fact that the PPPD is less radical than the regular Whipple procedure, and some surgeons find it technically easier. Our experience fails to show a distinct superiority of the PPPD over the Whipple operation.
HYPOTHESIS: Widespread use of computed tomography and ultrasound has led to the identification of increasing numbers of patients with asymptomatic cystic lesions of the pancreas. DESIGN: Retrospective case series of patients with pancreatic cystic lesions. SETTING: University-affiliated tertiary care referral center. PATIENTS: Two hundred twelve patients with pancreatic cystic lesions seen in our surgical practice during 5 years (April 1997-March 2002). MAIN OUTCOME MEASURES: Presence or absence of symptoms, cyst size and location, cytologic or pathologic diagnosis, surgical treatment, and outcome. RESULTS: Seventy-eight (36.7%) of 212 patients were asymptomatic. Incidental cysts were smaller (3.3 +/- 1.9 vs 4.6 +/- 2.7 cm; P<.001) and were found in older patients (65 +/- 13 vs 56 +/- 15 years; P<.001). Seventy-eight percent of the asymptomatic patients and 87% of those with symptoms underwent surgery, with a single operative death in the entire group (0.5%). Seventeen percent of asymptomatic cysts were serous cystadenomas; 28%, mucinous cystic neoplasms; 27%, intraductal papillary mucinous neoplasms; and 2.5%, ductal adenocarcinomas. The respective numbers for symptomatic cysts were 7%, 16%, 40%, and 9%. Ten percent of asymptomatic patients had a variety of other cystic lesions, and in 12%, no definitive cytologic or pathologic diagnosis was obtained. Overall, 17% of asymptomatic patients had in situ or invasive cancer, and 42% had a premalignant lesion. When evaluated as a function of size, only 1 (3.5%) of 28 asymptomatic cysts smaller than 2 cm had cancer compared with 13 (26%) of 50 cysts larger than 2 cm (P =.04). The proportion of premalignant lesions, however, remained high in both groups (46% and 38%, respectively). Pseudocysts comprised only 3.8% of asymptomatic cysts compared with 19.4% of symptomatic cysts (P =.003). CONCLUSIONS: Incidental pancreatic cysts are common, occur in older patients, are smaller than symptomatic cysts, and are unlikely to be pseudocysts. More than half of them are either malignant or premalignant lesions and therefore cannot be dismissed.
The huge changes brought about by minimal access surgery in the last 15 years tell us much about the dynamic state of surgical technology and the need for sudden accommodation to a new item or concept that has captured the public eye. The minimal access technology invites us to extrapolate improvements in ergonomics and visualization and the combination of diagnostic and therapeutic motives in the operating room. The need for proper sensors to provide haptics to our instruments is high. Smart materials, smart catheters, wireless connectivity, and integrated technology for plug-and-play use are very attractive subjects that will draw many resources toward their successful application to operating room issues. Collaboration among institutions and industry will be useful to achieve efficiency, synergy, and the critical mass of talent to solve the significant problems ahead.
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OBJECTIVE: To examine the hypothesis that elective laparoscopic repair should be routinely performed on patients with asymptomatic or minimally symptomatic paraesophageal hernias. SUMMARY BACKGROUND DATA: The management of asymptomatic paraesophageal hernias is a controversial issue. Most surgeons believe that all paraesophageal hernias should be corrected electively on diagnosis, irrespective of symptoms, to prevent the development of complications and avoid the risk of emergency surgery. METHODS: A Markov Monte Carlo decision analytic model was developed to track a hypothetical cohort of patients with asymptomatic or minimally symptomatic paraesophageal hernia and reflect the possible clinical outcomes associated with two treatment strategies: elective laparoscopic paraesophageal hernia repair (ELHR) or watchful waiting (WW). The input variables for ELHR were estimated from a pooled analysis of 20 published studies, while those for WW and emergency surgery were derived from the 1997 HCUP-NIS database and surgical literature published from 1964 to 2000. Outcomes for the two strategies were expressed in quality-adjusted life-years (QALYs). RESULTS: Analysis of the HCUP-NIS database showed that published studies overestimate the mortality of emergency surgery (17% vs. 5.4%). The mortality rate of ELHR was 1.4%. The annual probability of developing acute symptoms requiring emergency surgery with the WW strategy was 1.1%. For patients 65 years of age, ELHR resulted in reduction of 0.13 QALYs (10.78 vs. 10.65) compared with WW. The model predicted that WW was the optimal treatment strategy in 83% of patients and ELHR in the remaining 17%. The model was sensitive only to alterations of the mortality rates of ELHR and emergency surgery. CONCLUSIONS: If ELHR is routinely recommended, it would be more beneficial than WW in fewer than one of five patients. WW is a reasonable alternative for the initial management of patients with asymptomatic or minimally symptomatic paraesophageal hernias, and even if an emergency operation is required, the burden of the procedure is not as severe as was thought in the past.
Dysphagia after laparoscopic Nissen fundoplication (LNF) is commonly attributed to edema and/or improperly constructed wraps, and in some instances the cause can be difficult to identify. We report, for the first time, the development of secondary achalasia after LNF as a cause of late-onset postoperative dysphagia. A total of 250 consecutive patients undergoing LNF were analyzed for the development of postoperative dysphagia at a university hospital. Patients were considered to have secondary achalasia if they met the following four criteria: (1) preoperative manometry demonstrating normal peristalsis and normal lower esophageal sphincter (LES) relaxation; (2) lack of esophageal peristalsis on postoperative manometry or fluoroscopy with or without incomplete LES relaxation; (3) no mucosal lesions seen on endoscopy; and (4) dysphagia refractory to dilatation. The following three groups of patients were identified: patients who developed secondary achalasia (group A, n = 7); patients with persistent dysphagia requiring and responding to postoperative dilatation (group B, n = 12 patients); and patients whose postoperative recovery was not complicated by dysphagia (group C, n = 231). The groups were comparable in terms of all preoperative variables except for age. Patients in group A were older than those in group B (57 years [range 27 to 66 years] vs. 36.5 years [range 27 to 63 years], P = 0.028) but were not significantly older than patients in group C (45 years [range 20 to 84 years], P = 0.42). The onset of severe dysphagia was later in group A than in group B (135 days [range 15 to 300 days] vs. 20 days [range 9 to 70 days], P = 0.002). The median weight loss in group A was also significantly greater than in Group B (15 pounds [range 11 to 44 pounds] vs. 4 pounds [range 0 to 15 pounds], P = 0.0007). Two patients in group A who underwent reoperation failed to improve. Botulinum toxin injections were tried in two patients and Heller myotomy in one with good results. Nine patients in group B improved promptly after one dilatation, and three improved after two dilatations. Secondary achalasia should be considered as one of the causes of persistent dysphagia after an apparently successful antireflux operation. Secondary achalasia tends to occur in older patients and is characterized by a delayed onset of symptoms. Imaging studies are a reliable means of excluding mechanical obstruction as a cause of secondary achalasia, and a negative result should raise the suspicion of secondary achalasia. Esophageal motility studies are necessary to confirm the diagnosis. Failure to consider the diagnosis of secondary achalasia can lead to multiple fruitless attempts at dilatation or even inappropriate reoperations.