Reoperation for inguinal hernia recurrence in Ontario: a population-based study.

PURPOSE: Despite the frequency with which inguinal hernia repairs (IHR) are performed, the real-world comparative effectiveness of laparoscopic versus open repairs is not well established. We compared the rate of recurrent inguinal hernia after laparoscopic and open mesh procedures. METHODS: We designed a population-based retrospective cohort study using linked administrative databases including adult patients in Ontario, Canada, who underwent primary IHR from April 1, 2003 to December 31, 2012. Patients were followed to August 31, 2014. Our primary outcome was reoperation for recurrent IHR, with covariate adjustment using Cox proportional hazards modeling. We constructed separate models to evaluate the effect of surgeon caseload on recurrence rates. RESULTS: We identified 93,501 adults undergoing primary IHR (85.4% open with mesh and 14.6% laparoscopic) with a median follow-up of 5.5 years. The 5-year cumulative risk of recurrent IHR was 2.0% in the open group and 3.4% in the laparoscopic group. After adjusting for patient and surgeon factors, we found that patients who underwent laparoscopic repair had a higher risk of recurrent IHR than those who underwent open repair when annual surgeon volume in the preceding year was ≤25 technique-specific cases (HR 1.76; 95% CI 1.45-2.13) or 26-50 technique-specific cases (HR 1.78; 95% CI 1.08-2.93). Few high-volume laparoscopic surgeons (> 50 cases/year) could be identified. Laparoscopic IHR did not carry a higher risk of recurrence for patients whose surgeons had performed > 50 technique-specific cases in the preceding year (HR 1.21; 95% CI 0.45-3.26). CONCLUSION: Laparoscopic IHR is generally associated with a higher risk of recurrence than open IHR. Though high-volume surgeons may be able to achieve equivalent results with laparoscopic and open techniques, few surgeons in our study population met this volume criterion for laparoscopic repairs.

Treatment choices and outcomes of patients with manometrically diagnosed achalasia.

This prospective population-based study was designed to evaluate treatment choices in patients with new manometrically diagnosed achalasia and their outcomes. Patients referred to the esophageal function laboratory were enrolled after a new manometric diagnosis of achalasia. Patients completed an initial achalasia symptom score validated questionnaire on their symptom severity, duration, treatment pre-diagnosis and Medical Outcomes Study 36-item Short-Form (SF-36) survey. Treatment decisions were made by the referring physician and the patient. Follow-up questionnaires were completed every 3 months for 1 year. Patients who chose not to undergo treatment at 1-year follow-up completed another questionnaire after 5 years. Between January 2004 and January 2005, 83 of 124 eligible patients were enrolled. Heller myotomy was performed on 31 patients, three patients received botulinum toxin injections, and 25 patients received 29 pneumatic balloon dilatations. Twenty-four patients chose to receive no treatment. Following treatment, patients treated with surgery, dilatation and botulinum toxin had an average improvement in achalasia symptom score of 23 +/- 12.2, 17 +/- 10.9, and 9 +/- 14, respectively. Patients receiving no treatment had worsening symptoms with a symptom score change of -3.5 +/- 11.4. Surgery and dilatation resulted in significant improvement (P < 0.01) relative to no treatment. In univariate logistic regression, symptom severity score (odds ratio [OR] 1.04, 95% confidence interval [CI] 1.00 to 1.08), sphincter tone (OR 1.04, 95% CI 1.00 to 1.09), difficulty swallowing liquids (OR 3.21, 95% 1.15 to 8.99), waking from sleep (OR 2.75, 95% 1.00 to 7.61), and weight loss (OR 5.99, 95% CI 1.93 to 18.58) were all significant in predicting that patients would select treatment. In the multivariate analysis, older age (OR 1.05, 95% CI 1.01 to 1.09) and weight loss (OR 3.91, 95% CI 1.02 to 15.2) were statistically significant for undergoing treatment. At 5 years, five (21%) of those who had initially declined treatment at 1 year ultimately chose a treatment. Patients who finally chose Heller myotomy had lower mental component dimension scores on the SF-36 at 1 year than those who did not. This study shows that almost one third of patients with manometrically diagnosed achalasia choose not to undergo treatment within 1 year of their diagnosis. Patients who are more symptomatic appear to be more likely to undergo treatment by univariate analysis. In multivariate analysis, increasing age and weight loss are predictive of those who will undergo treatment, with weight loss having the greatest influence. Patients who choose not to undergo treatment make lifestyle changes to maintain their quality of life, and only a minority of them ultimately undergo treatment.

Surgical process improvement tools: defining quality gaps and priority areas in gastrointestinal cancer surgery.

BACKGROUND: Surgery is a cornerstone of cancer treatment, but significant differences in the quality of surgery have been reported. Surgical process improvement tools (spits) modify the processes of care as a means to quality improvement (qi). We were interested in developing spits in the area of gastrointestinal (gi) cancer surgery. We report the recommendations of an expert panel held to define quality gaps and establish priority areas that would benefit from spits. METHODS: The present study used the knowledge-to-action cycle was as a framework. Canadian experts in qi and in gi cancer surgery were assembled in a nominal group workshop. Participants evaluated the merits of spits, described gaps in current knowledge, and identified and ranked processes of care that would benefit from qi. A qualitative analysis of the workshop deliberations using modified grounded theory methods identified major themes. RESULTS: The expert panel consisted of 22 participants. Experts confirmed that spits were an important strategy for qi. The top-rated spits included clinical pathways, electronic information technology, and patient safety tools. The preferred settings for use of spits included preoperative and intraoperative settings and multidisciplinary contexts. Outcomes of interest were cancer-related outcomes, process, and the technical quality of surgery measures. CONCLUSIONS: Surgical process improvement tools were confirmed as an important strategy. Expert panel recommendations will be used to guide future research efforts for spits in gi cancer surgery.

How do medical device manufacturers' websites frame the value of health innovation? An empirical ethics analysis of five Canadian innovations.

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology's promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate "value proposition" of their innovation and seek to respond to what they consider the key expectations of their customers. Our analysis shows that the manufacturers' framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians' and patients' expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others.

The prevalence of autoimmune disease in patients with esophageal achalasia.

Achalasia is a rare disease of the esophagus that has an unknown etiology. Genetic, infectious, and autoimmune mechanisms have each been proposed. Autoimmune diseases often occur in association with one another, either within a single individual or in a family. There have been separate case reports of patients with both achalasia and one or more autoimmune diseases, but no study has yet determined the prevalence of autoimmune diseases in the achalasia population. This paper aims to compare the prevalence of autoimmune disease in patients with esophageal achalasia to the general population. We retrospectively reviewed the charts of 193 achalasia patients who received treatment at Toronto's University Health Network between January 2000 and May 2010 to identify other autoimmune diseases and a number of control conditions. We determined the general population prevalence of autoimmune diseases from published epidemiological studies. The achalasia sample was, on average, 10-15 years older and had slightly more men than the control populations. Compared to the general population, patients with achalasia were 5.4 times more likely to have type I diabetes mellitus (95% confidence interval [CI] 1.5-19), 8.5 times as likely to have hypothyroidism (95% CI 5.0-14), 37 times as likely to have Sjögren's syndrome (95% CI 1.9-205), 43 times as likely to have systemic lupus erythematosus (95% CI 12-154), and 259 times as likely to have uveitis (95% CI 13-1438). Overall, patients with achalasia were 3.6 times more likely to suffer from any autoimmune condition (95% CI 2.5-5.3). Our findings are consistent with the impression that achalasia's etiology has an autoimmune component. Further research is needed to more conclusively define achalasia as an autoimmune disease.

Optimal treatment for severe neurogenic bowel dysfunction after chronic spinal cord injury: a decision analysis.

BACKGROUND: When conservative management fails in patients with chronic spinal cord injury (SCI) and neurogenic bowel dysfunction, clinicians have to choose from a variety of treatment options which include colostomy, ileostomy, Malone anterograde continence enema (MACE) and sacral anterior root stimulator (SARS) implantation. This study employed a decision analysis to examine the optimal treatment for bowel management of young individuals with chronic refractory constipation in the setting of chronic SCI. METHODS: A decision analysis was created to compare the four surgical strategies using baseline analysis, one-way and two-way sensitivity analyses, 'worst scenario' and 'best scenario' sensitivity analyses, and probabilistic sensitivity analyses. Quality-adjusted life expectancy (QALE) was the primary outcome. RESULTS: The baseline analysis indicated that patients who underwent the MACE procedure had the highest QALE value compared with the other interventions. Sensitivity analyses showed that these results were robust. CONCLUSION: The MACE procedure may provide the best long-term outcome in terms of the probability of improving bowel function, reducing complication rates and the incidence of autonomic dysreflexia, and being congruent with patients' preferences. The analysis was sensitive to changes in assumptions about quality of life/utility, and thus the results could change if more specific estimates of utility became available.

A research agenda for gastrointestinal and endoscopic surgery.

BACKGROUND: Development of a research agenda may help to inform researchers and research-granting agencies about the key research gaps in an area of research and clinical care. The authors sought to develop a list of research questions for which further research was likely to have a major impact on clinical care in the area of gastrointestinal and endoscopic surgery. METHODS: A formal group process was used to conduct an iterative, anonymous Web-based survey of an expert panel including the general membership of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). In round 1, research questions were solicited, which were categorized, collapsed, and rewritten in a common format. In round 2, the expert panel rated all the questions using a priority scale ranging from 1 (lowest) to 5 (highest). In round 3, the panel re-rated the 40 questions with the highest mean priority score in round 2. RESULTS: A total of 241 respondents to round 1 submitted 382 questions, which were reduced by a review panel to 106 unique questions encompassing 33 topics in gastrointestinal and endoscopic surgery. In the two successive rounds, respectively, 397 and 385 respondents ranked the questions by priority, then re-ranked the 40 questions with the highest mean priority score. High-priority questions related to antireflux surgery, the oncologic and immune effects of minimally invasive surgery, and morbid obesity. The question with the highest mean priority ranking was: "What is the best treatment (antireflux surgery, endoluminal therapy, or medication) for GERD?" The second highest-ranked question was: "Does minimally invasive surgery improve oncologic outcomes as compared with open surgery?" Other questions covered a broad range of research areas including clinical research, basic science research, education and evaluation, outcomes measurement, and health technology assessment. CONCLUSIONS: An iterative, anonymous group survey process was used to develop a research agenda for gastrointestinal and endoscopic surgery consisting of the 40 most important research questions in the field. This research agenda can be used by researchers and research-granting agencies to focus research activity in the areas most likely to have an impact on clinical care, and to appraise the relevance of scientific contributions.

What is a meant when a laparoscopic surgical procedure is described as "safe"?

BACKGROUND: The literature on laparoscopic surgery contains many studies concluding that a procedure is "safe." This study aimed to review systematically articles from the past 10 years that judged a laparoscopic technique for colon resection and anastomosis to be "safe." METHODS: The authors searched the Medline database from January 1995 to August 2005 using the search terms "laparoscopic," "colon," and "safe," selecting studies of laparoscopic colon resection or laparoscopic techniques of colonic anastomosis. They calculated exact 95% confidence intervals around estimates of the risk for death reported in the studies to determine the upper limit of the possible risk for death in a study reporting no deaths. RESULTS: Of 135 studies matching the search criteria, 41 (30%) described operations involving laparoscopic colonic resection or anastomosis. These studies enrolled a mean number of 233 subjects. There were 26 retrospective studies, 12 prospective studies, 2 randomized control trials, and 1 case report. The estimated upper 95% confidence limits for studies reporting mortality ranged from 1.66% to 97.5%. Of the studies that reported mortality and concluded that laparoscopic colon surgery is "safe," 77.8% could not exclude a mortality rate higher than 5%. CONCLUSION: Many studies concluding that laparoscopic colon surgery is "safe" could not exclude a high risk of operative mortality. The term "safe" is not a useful descriptor of the relative safety of laparoscopic surgical procedures, and statements about the safety of a surgical procedure should be justified with precise estimates and confidence intervals of the risk for adverse events.

Accuracy of administrative health data for the diagnosis of upper gastrointestinal diseases.

BACKGROUND: The use of administrative health data is increasingly common for the study of various medical and surgical diseases. The validity of diagnosis codes for the study of benign upper gastrointestinal disorders has not been well studied. METHODS: The authors abstracted the charts for 590 adult patients who underwent upper gastrointestinal endoscopy between January 1, 2000 and June 30, 2001 in Toronto, Ontario, Canada. Clinical diagnoses from medical records were compared with International Classification of Diseases Version 9 (ICD-9) codes in electronic hospital discharge abstracts. The primary analysis aimed to determine the sensitivity, specificity, and positive predictive value (PPV) of a most responsible "esophagitis" diagnosis code for the prediction of esophagitis. Secondary analyses determined the performance characteristics of the diagnostic codes for esophageal ulcer, esophageal stricture, gastroesophageal reflux disease (GERD), gastritis, gastric ulcer, and duodenal ulcer. RESULTS: The authors linked 500 patient records to electronic discharge abstracts. When listed as the most responsible diagnosis for admission, the ICD-9 codes for esophagitis showed a sensitivity of 46.79%, a specificity of 98.83%, and a PPV of 94.81%. When listed as a secondary diagnosis, the ICD-9 codes showed a sensitivity of 70.51%, a specificity of 97.67%, and a PPV of 93.22%. The diagnostic properties of ICD-9 codes for GERD (most responsible, secondary) were as follows: sensitivity (56.10%, 78.66%), specificity (98.51%, 96.73%), and PPV (94.84%, 92.14%). CONCLUSIONS: The ICD-9 diagnosis codes for benign upper gastrointestinal diseases are highly specific and associated with strong PPVs, but have poor sensitivity.

Does it matter what a hospital is "high volume" for? Specificity of hospital volume-outcome associations for surgical procedures: analysis of administrative data.

OBJECTIVE: To determine whether the improved outcome of a surgical procedure in high volume hospitals is specific to the volume of the same procedure. DESIGN AND SETTING: Analysis of secondary data in Ontario, Canada. PARTICIPANTS: Patients having an oesophagectomy, colorectal resection for cancer, pancreaticoduodenectomy, major lung resection for cancer, or repair of an unruptured abdominal aortic aneurysm between 1994 and 1999. MAIN OUTCOME MEASURES: Odds ratio for death within 30 days of surgery in relation to the hospital volume of the same surgical procedure and the hospital volume of the other four procedures. Estimates were adjusted for age, sex, and comorbidity and accounted for hospital level clustering. RESULTS: With the exception of colorectal resection, 30 day mortality seemed to be inversely related not only to the hospital volume of the same procedure but also to the hospital volume of most of the other procedures. In some cases the effect of the volume of a different procedure was stronger than the effect of the volume of the same procedure. For example, the association of mortality from pancreaticoduodenectomy with hospital volume of lung resection (odds ratio for death in hospitals with a high volume of lung resection compared with low volume 0.36, 95% confidence interval 0.23 to 0.57) was much stronger than the association of mortality from pancreaticoduodenectomy with hospital volume of pancreaticoduodenectomy (0.76, 0.44 to 1.32). CONCLUSION: The inverse association between high volume of procedure and risk of operative death is not specific to the volume of the procedure being studied.

The surgeon on call is a strong factor determining the use of a laparoscopic approach for appendectomy.

BACKGROUND: Laparoscopic and open approaches are commonly used for appendectomy. No previous studies have specifically examined which factors determine whether a laparoscopic or open approach is used for appendectomy. METHODS: We conducted a retrospective chart review of 140 patients who underwent a laparoscopic (n = 60) or open (n = 80) appendectomy between January 2000 and April 2001 at our hospital. Medical records were reviewed, and the data were analyzed using chi-square analysis, the Wilcoxon rank-sum test, and multivariate logistic regression. We studied patient age, gender, type of surgeon on call, leukocyte count, pathology, and the use of diagnostic imaging to determine whether there was any association with the use of a laparoscopic approach. RESULTS: The type of surgeon on call was strongly correlated with a laparoscopic approach. Of the 61 appendectomies performed by laparoscopic surgeons (those who use laparoscopy for operations other than appendectomies and cholecystectomies), 55 (90%) were laparoscopic and 6 (10%) were open. Of the 79 appendectomies performed by nonlaparoscopic surgeons, 5 (6%) were laparoscopic and 74 (94%) were open (multivariate odds ratio, 136; 95% confidence interval, 39-475; p < 0.001). CONCLUSIONS: The surgeon on call when a patient is admitted is an important factor determining whether a patient will receive a laparoscopic or open appendectomy.

The effect of intraoperative bupivacaine administration on parenteral narcotic use after laparoscopic appendectomy.

BACKGROUND: Little is known about the effect that prophylactic administration of local anesthesia into surgical incisions has on pain and analgesic use after laparoscopic appendectomy. We examined how preemptive infiltration of a local anesthetic affected the use of parenteral narcotics after laparoscopic appendectomy. METHODS: We conducted a retrospective chart review of 60 patients who underwent a laparoscopic appendectomy from January 2000 to April 2001 at our institution. We studied the association between prophylactic bupivacaine analgesia and patterns of postoperative parenteral narcotic use. RESULTS: Of 46 patients who received intraoperative bupivacaine, 24 (52%) required postoperative parenteral narcotics as compared with 12 (86%) of 14 patients who did not receive bupivacaine (risk difference, 34%; 95% confidence interval [CI], 10-51%; p = 0.02). After adjustment for other factors, the patients who received prophylactic bupivacaine were much less likely to receive parenteral narcotics during their postoperative hospital stay than the patients who did not receive prophylactic bupivacaine (odds ratio, 0.2; 95% CI, 0.1-0.9; p = 0.03). Furthermore, the patients who received prophylactic bupivacaine required fewer doses (median number of doses, 0.5; interquartile range [IQR], 0-2) of parenteral narcotics postoperatively than those who did not receive bupivacaine (median, 2; IQR, 1-4; p value for comparison, 0.03). CONCLUSION: Intraoperative bupivacaine infiltrated locally into surgical wounds is associated with both a decreased need for postoperative parenteral narcotics and a reduced number of doses in patients who have undergone a laparoscopic appendectomy.

Laparoscopic antireflux surgery in the elderly.

BACKGROUND: Laparoscopic antireflux surgery is frequently denied to older patients with gastroesophageal reflux disease (GERD) because of a perceived higher operative complication rate, a decreased impact of the intervention on quality of life, and decreased cost effectiveness. This study compares disease severity, surgical outcomes, and impact on quality of life between elderly and young patients with GERD. METHODS: Patients were selected from a prospectively maintained database of 1100 patients who underwent various laparoscopic esophageal procedures at our institution. Only patients having chronic intractable GERD and a minimum 6 months' follow-up were included in the study. Thirty elderly patients with a mean age of 71.2 years (SD +/- 5.6) were compared with a group of 30 younger patients (mean age, 43.9 +/- 12.8 years). Comparisons were made between subjective and objective outcomes, operative results, and health-related quality of life (HQRL) scores using SF-36 instruments. RESULTS: The preoperative symptom assessment scores presenting frequency of symptoms on a 0-4 scale), and preoperative pH and manometry data were comparable in the two groups. Elderly patients had significantly higher ASA (American Society of Anesthesiologists) scores. Each group demonstrated a significant improvement in the postoperative symptom assessment scores and the esophageal functional studies (p<0.05). However, no significant differences were found in terms of postoperative complications, postoperative hospital stay, postoperative symptom scores, Demeester scores, or the HRQL data. CONCLUSION: Laparoscopic antireflux surgery in elderly patients improves acid reflux and appears to be safe and effective as measured by postoperative testing in elderly and young patients.

Outcomes of laparoscopic herniorrhaphy without fixation of mesh to the abdominal wall.

BACKGROUND: Recently there has been interest in performing laparoscopic herniorrhaphies without the use of staples or tacks to fix the mesh. Although mesh fixation has been linked to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. This study evaluates the outcomes of laparoscopic herniorrhapies performed with and without mesh fixation at our institution. METHODS: We retrospectively evaluated our last 172 laparoscopic herniorrhaphies, which span a period of conversion from staple fixation to nonfixation of total extraperitoneal herniorrhaphies using systematic chart review and follow-up self-administered questionnaires. The outcomes assessed were the incidences of postoperative neuralgia and hernia recurrence. Adjustment for important prognostic factors was achieved using Cox regression for estimating the risk of recurrence, and multiple logistic regression for estimating the risk of neuropathic complications. RESULTS: Of 172 laparoscopic herniorrhaphies performed in 129 patients since July 1993, 105 were accomplished without mesh fixation, and 67 were performed with fixation of mesh to the abdominal wall. There were no significant differences in demographics between the two groups. A trend toward a higher incidence of neuropathic complications was observed in the mesh-fixation group (risk ratio [RR], 2.2; 95% CI, 0.5-10). A nonsignificant increased risk of hernia recurrence with fixation of mesh was observed (4.2 vs 1.6 per 100 hernia-years at risk; RR, 2.3; 95% CI, 0.4-13.10), but this finding may be associated with a selection bias with regard to giant hernia defects. CONCLUSIONS: Our data suggest that mesh fixation to the abdominal wall may be avoided in total extraperitoneal repairs without increasing the risk of hernia recurrence and neuropathic complications. The increased risk of recurrence observed with mesh fixation possibly results from selection bias. Large randomized controlled studies are needed to determine whether mesh fixation is truly related to neuropathic complications and the incidence of recurrence.

Dedicated minimally invasive surgery suites increase operating room efficiency.

BACKGROUND: The rapid adoption of laparoscopic surgery since the late 1980s added tremendous complexity into the operating room (OR) environment. For each case, a plethora of additional equipment-including monitors, video equipment, wiring, tubing, and cords-had to be set up, prolonging OR turnover time and decreasing OR efficiency. In 1993, the concept of designated minimally invasive surgery (MIS) suites was introduced. MIS suites integrated monitors and video equipment into the OR on ceiling-mounted columns and moved the controls to a centralized nursing station. The overall effect of this innovation on OR efficiency has not been measured. METHODS: Five RNs with varying degrees of MIS experience were instructed on video setup and put-away criteria and then timed while performing a set of standardized tasks. Each set of tasks was performed twice using a standardized surgery model. Differences in setup and put-away times between MIS suites and standard ORs were tested using the t-test for paired comparisons. RESULTS: The mean +/- standard deviation (SD) video setup times were 27.9 +/- 5.3 sec (MIS) and 254.3 +/- 54.0 sec (standard); the put-away times were 19.8 +/- 2.7 sec (MIS) and 222.3 +/- 26.0 sec (standard). The mean difference +/- standard error (SE) in both the setup (226.4 +/- 16.9 sec, p = 0.0001) and put-away times (202.5 +/- 8.6, p = 0.0001) were large and statistically significant. CONCLUSION: Using a simulation model, we have demonstrated that the use of a MIS suite reduces video setup and put-away time significantly, with the potential for significant associated cost savings. This provides just one justification for the high cost of building such "ORs of the future."

Incidence of cancer of the pancreas, extrahepatic bile duct and ampulla of Vater in the United States, before and after the introduction of laparoscopic cholecystectomy.

BACKGROUND: Some epidemiologic studies have identified cholecystectomy as a risk factor for pancreatic and biliary cancer. METHODS: We compared the incidence of cancers of the pancreas, extrahepatic bile duct and ampulla of Vater before and after the widespread adoption of laparoscopic cholecystectomy in the United States in 1991, when the use of cholecystectomy increased dramatically. RESULTS: Compared with 1980 to 1991, there was no increase in the incidence of cancer of the pancreas (adjusted incidence rate ratio [IRR] 0.97, 95% confidence interval [CI] 0.94 to 0.99) or extrahepatic bile duct (IRR 0.80, 95% CI 0.74 to 0.87) during 1992 to 1996. There was a small increase in the incidence of ampullary cancer (IRR 1.14, 95% CI 1.03 to 1.26). CONCLUSIONS: We did not find clear evidence of a short-term increase in the incidence of cancers of the pancreas, bile duct, and ampulla of Vater, that was attributable to the increased use of cholecystectomy.