Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.

BACKGROUND: Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine). METHODS: Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year. RESULTS: A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17). CONCLUSIONS: Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).

Surgical management of obesity.

Weight loss surgery is the most effective intervention for addressing obesity and related metabolic disorders such as diabetes. We describe common surgical procedures as well as emerging and investigational procedures in terms of their capacity to induce weight reduction and their risk profiles. We then discuss the impact of weight loss surgery on important obesity related disorders including diabetes, cardiovascular disease, and non-alcoholic fatty liver disease. The question of operative choice is discussed with respect to benefits and risks of common procedures. Reoperative weight loss surgery, an increasingly common element of weight loss surgical practice, is reviewed. We briefly discuss the metabolic mechanism of action of weight loss surgery. Lack of access to and under-utilization of weight loss surgery represent important challenges to adequate obesity treatment, and we review these topics as well.

Factors Associated With Long-term Outcomes of Umbilical Hernia Repair.

Importance: Umbilical hernia repair is one of the most commonly performed general surgical procedures. However, there is little consensus about the factors that lead to umbilical hernia recurrence. Objective: To better understand the factors associated with long-term umbilical hernia recurrence. Design, Setting, and Participants: A retrospective cohort of 332 military veteran patients who underwent umbilical hernia repair was studied between January 1, 1998, and December 31, 2008, at the VA Boston Healthcare System. Recurrence and mortality outcomes were tracked from that period until June 1, 2014. Data were collected on patient characteristics, operative, and postoperative factors and univariate and multivariable analyses were used to assess which factors were significantly associated with umbilical hernia recurrence and mortality. All patients with primary umbilical hernia repair, with or without a concurrent unrelated procedure, were included in the study. Patients excluded were those who underwent umbilical hernia repair as a part of another major planned procedure with abdominal incisions. Data were collected from June 1, 2014, to November 1, 2015. Statistical analysis was performed from November 2, 2015, to April 1, 2016. Main Outcomes and Measures: The primary study outcomes were umbilical hernia recurrence and death. Results: Of the 332 patients in this study, 321 (96.7%) were male, mean age was 58.4 years, and mean (SD) time of follow-up was 8.5 (4.1) years. The hernia recurrence rate was 6.0% (n = 20) at a mean 3.1 years after index repair (median, 1.0-year; range, 0.33-13 years). The primary suture repair recurrence rate was 9.8% (16 of 163 patients), and the mesh repair recurrence rate was 2.4% (4 of 169 patients). On univariate analysis, ascites (P = .02), liver disease (P = .02), diabetes (P = .04), and primary suture (nonmesh) repairs (P = .04) were significantly associated with increased recurrence rates. Patients who had a history of hernias (125 [39%]) were less likely to have umbilical hernia recurrences (χ21 = 4.65, P = .03). On multivariable regression analysis, obesity and ascites were associated with significantly increased odds ratios of recurrence of 3.3 (95% CI, 1.0-10.1) and 8.0 (95% CI, 1.8-34.4), respectively. Mesh repair was seen to decrease recurrence with odds of 0.28 (95% CI, 0.08-0.95). There was no significant difference in complication rates between mesh repair and primary suture repair. The survival rate was 73% (n = 242) at the end of the study. Factors associated with mortality were older age, smoking, liver disease, ascites, emergency or semiurgent repair, and need for intraoperative bowel resection. Conclusions and Relevance: Ascites, liver disease, diabetes, obesity, and primary suture repair without mesh are associated with increased umbilical hernia recurrence rates. Elective umbilical hernia repair with mesh should be considered in patients with multiple comorbidities given that the use of mesh offers protection from recurrence without major morbidity.

Surgeons' Disclosures of Clinical Adverse Events.

Importance: Surgeons are frequently faced with clinical adverse events owing to the nature of their specialty, yet not all surgeons disclose these events to patients. To sustain open disclosure programs, it is essential to understand how surgeons are disclosing adverse events, factors that are associated with reporting such events, and the effect of disclosure on surgeons. Objective: To quantitatively assess surgeons' reports of disclosure of adverse events and aspects of their experiences with the disclosure process. Design, Setting, and Participants: An observational study was conducted from January 1, 2011, to December 31, 2013, involving a 21-item baseline questionnaire administered to 67 of 75 surgeons (89%) representing 12 specialties at 3 Veterans Affairs medical centers. Sixty-two surveys of their communication about adverse events and experiences with disclosing such events were completed by 35 of these 67 surgeons (52%). Data were analyzed using mixed linear random-effects and logistic regression models. Main Outcomes and Measures: Self-reports of disclosure assessed by 8 items from guidelines and pilot research, surgeons' perceptions of the adverse event, reported personal effects from disclosure, and baseline attitudes toward disclosure. Results: Most of the surgeons completing the web-based surveys (41 responses from men and 21 responses from women) used 5 of the 8 recommended disclosure items: explained why the event happened (55 of 60 surveys [92%]), expressed regret for what happened (52 of 60 [87%]), expressed concern for the patient's welfare (57 of 60 [95%]), disclosed the adverse event within 24 hours (58 of 60 [97%]), and discussed steps taken to treat any subsequent problems (59 of 60 [98%]). Fewer surgeons apologized to patients (33 of 60 [55%]), discussed whether the event was preventable (33 of 60 [55%]), or how recurrences could be prevented (19 of 59 [32%]). Surgeons who were less likely to have discussed prevention (33 of 60 [55%]), those who stated the event was very or extremely serious (40 of 61 surveys [66%]), or reported very or somewhat difficult experiences discussing the event (16 of 61 [26%]) were more likely to have been negatively affected by the event. Surgeons with more negative attitudes about disclosure at baseline reported more anxiety about patients' surgical outcomes or events following disclosure (odds ratio, 1.54; 95% CI, 1.16-2.06). Conclusions and Relevance: Surgeons who reported they were less likely to discuss preventability of the adverse event, or who reported difficult communication experiences, were more negatively affected by disclosure than others. Quality improvement efforts focused on recognizing the association between disclosure and surgeons' well-being may help sustain open disclosure policies.

Tumor size and depth predict rate of lymph node metastasis in colon carcinoids and can be used to select patients for endoscopic resection.

BACKGROUND: Regional lymphadenectomy is recommended for all colon carcinoids, whereas resection without lymphadenectomy is accepted for selected appendiceal and rectal carcinoids. We examined the relation of tumor size and depth to lymph node metastasis in order to determine whether colon carcinoids could be selected for endoscopic resection. METHODS: Patients were identified from the Surveillance Epidemiology and End Results Registry. The Pearson chi-square and the log rank tests were used. P < 0.05 was considered significant. RESULTS: We identified 929 patients who underwent resection of localized colon carcinoids without distant metastasis diagnosed from 1973 to 2006. The diagnosis of small and superficial tumors increased over time (p < 0.001). The presence of lymph node metastasis was adversely associated with survival (p < 0.001); however, there was only a trend toward independence on multivariate analysis (p = 0.054). Tumor size and depth were associated with lymph node metastasis (p < 0.001, p < 0.001). Tumors were subgrouped by size and depth to find cases with a low risk of lymph node metastasis. Intramucosal tumors < 1 cm had a 4% rate of lymph node metastasis, while all other subgroups had rates ≥ 14%. CONCLUSION: Tumor size and depth predict lymph node metastasis for colon carcinoids. Endoscopic resection may be appropriate for intramucosal tumors <1 cm.

Mesh infection in ventral incisional hernia repair: incidence, contributing factors, and treatment.

BACKGROUND: Prosthetic mesh infection is a catastrophic complication of ventral incisional hernia (VIH) repair. METHODS: The current surgical literature was reviewed to determine the incidence, microbiology, risk factors, and treatment of mesh infections. RESULTS: Mesh infections tend to present late. Diagnosis depends on high clinical suspicion and relies on culture of the fluid surrounding the mesh or of the mesh itself. Risk factors may include a high body mass index (obesity); chronic obstructive pulmonary disease; abdominal aortic aneurysm repair; prior surgical site infection; use of larger, microporous, or expanded polytetrafluoroethylene mesh; performance of other procedures via the same incision at the time of repair; longer operative time; lack of tissue coverage of the mesh; enterotomy; and enterocutaneous fistula. The best treatment is prevention. Treatment of mesh infection is evolving on a case-by-case basis from explantation toward mesh salvage, to prevent complications such as hernia recurrence. CONCLUSION: Higher-quality reporting on mesh infection in VIH repair must be achieved through better classification and quantification of these infections. Tactics to avoid mesh infection should be based on best evidence and high-quality prospective trials and observational studies.

Best practice updates for pediatric/adolescent weight loss surgery.

The objective of this study is to update evidence-based best practice guidelines for pediatric/adolescent weight loss surgery (WLS). We performed a systematic search of English-language literature on WLS and pediatric, adolescent, gastric bypass, laparoscopic gastric banding, and extreme obesity published between April 2004 and May 2007 in PubMed, MEDLINE, and the Cochrane Library. Keywords were used to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence-based models. In light of evidence on the natural history of obesity and on outcomes of WLS in adolescents, guidelines for surgical treatment of obesity in this age group need to be updated. We recommend modification of selection criteria to include adolescents with BMI >or= 35 and specific obesity-related comorbidities for which there is clear evidence of important short-term morbidity (i.e., type 2 diabetes, severe steatohepatitis, pseudotumor cerebri, and moderate-to-severe obstructive sleep apnea). In addition, WLS should be considered for adolescents with extreme obesity (BMI >or= 40) and other comorbidities associated with long-term risks. We identified >1,085 papers; 186 of the most relevant were reviewed in detail. Regular updates of evidence-based recommendations for best practices in pediatric/adolescent WLS are required to address advances in technology and the growing evidence base in pediatric WLS. Key considerations in patient safety include carefully designed criteria for patient selection, multidisciplinary evaluation, choice of appropriate procedure, thorough screening and management of comorbidities, optimization of long-term compliance, and age-appropriate fully informed consent.