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1.  Lymphadenectomy and risk of reoperation or mortality shortly after surgery for oesophageal cancer 
Scientific Reports  2016;6:36092.
The prognostic role of lymphadenectomy during surgery for oesophageal cancer is questioned. We aimed to test whether higher lymph node harvest increases the risk of early postoperative reoperation or mortality. A population-based cohort study including almost all patients who underwent resection for oesophageal cancer in Sweden in 1987–2010. Data were collected from medical records and well-established nationwide Swedish registries. The exposures were number of removed lymph nodes (primary) and number of node metastases (secondary). The main study outcome was reoperation/mortality within 30 days of primary surgery. Relative risks (RRs) with 95% confidence intervals (CIs) were calculated using Poisson regression, adjusted for age, sex, co-morbidity, neoadjuvant therapy, tumour stage, tumour histology, surgeon volume, and calendar period. Among 1,820 participants, the risk of reoperation/mortality did not increase with greater lymph node harvest (RR = 0.98, 95%CI 0.96–1.00, discrete variable) or with greater number of removed metastatic nodes (RR = 1.00, 95% CI 0.95–1.05, discrete variable). Similarly, in stratified analyses within pre-defined categories of tumor stage, surgeon volume and calendar period, increased number of removed nodes or node metastases did not increase the risk of reoperation/mortality. Lymphadenectomy during oesophageal cancer surgery is a safe procedure in the short term perspective.
doi:10.1038/srep36092
PMCID: PMC5086836  PMID: 27796333
2.  Applied investigation of person-specific and context-specific factors on postoperative recovery and clinical outcomes of patients undergoing gastrointestinal cancer surgery: multicentre European study 
BMJ Open  2016;6(10):e012236.
Introduction
Cancer treatments have greatly advanced over the past two decades causing survival improvements and reduced complications from cancer surgery. However, the cancer diagnosis and the effects of treatment modalities pose a major risk to patients' psychological well-being. Given current interest and emerging evidence about the importance of psychological and social factors on cancer survival and coping with cancer treatments, this study will build and expand research in order to identify key modifiable psychosocial variables that contribute to better physical and mental health following gastrointestinal cancer (GIC) surgery.
Objectives
To elucidate the incidence of postoperative psychiatric morbidity within 6 months following GIC surgery. To identify key measurable modifiable preoperative psychological factors that can significantly affect postoperative psychiatric morbidity in patients undergoing surgery for GIC. To clarify the changes seen in a patient's psychological well-being during their treatment pathway for GIC.
Methods and analysis
This multicentre study has an observational longitudinal study design. In total, 1000 patients will be screened with a multicomponent psychological questionnaire at four different time points: at diagnosis, preoperatively, 1 and 6 months after surgery. Data from this questionnaire will be linked to postoperative complications including psychiatric morbidity, length of hospital stay and recovery to normal activity.
Ethics and dissemination
NHS Health Research Authority approval was gained on (REC reference 15.LO/1847) for the completion of this study. Multiple platforms will be used for the dissemination of the research data, including international clinical and patient group presentations and publication of research outputs in a high impact clinical journal.
doi:10.1136/bmjopen-2016-012236
PMCID: PMC5093381  PMID: 27798009
PSYCHIATRY; SURGERY
3.  Surgery during holiday periods and prognosis in oesophageal cancer: a population-based nationwide Swedish cohort study 
BMJ Open  2016;6(9):e013069.
Objective
Previous studies indicate an increased short-term and long-term mortality from major cancer surgery performed towards the end of the working week or during the weekend. We hypothesised that the prognosis after major cancer surgery is also negatively influenced by surgery conducted during holiday periods.
Setting
Population-based nationwide Swedish cohort study.
Participants
Patients undergoing oesophagectomy for oesophageal cancer between 1987 and 2010. Among 1820 included patients, 206 (11.3%) and 373 (20.5%) patients were operated on during narrow and wide holiday periods, respectively.
Interventions
Narrow (7 weeks) and wide (14 weeks) Swedish holiday periods.
Primary and secondary outcome measures
90-day all-cause, 5-year all-cause and 5-year disease-specific mortality.
Results
Narrow holiday period did not increase all-cause 90-day (HR=0.84, 95% CI 0.53 to 1.33), all-cause 5-year (HR=1.01, 95% CI 0.85 to 1.21) or disease-specific 5-year mortality (HR=1.04, 95% CI 0.87 to 1.26). Similarly, wide holiday period did not increase the risk of 90-day (HR=0.79, 95% CI 0.55 to 1.13), all-cause 5-year (HR=0.96, 95% CI 0.84 to 1.1) or disease-specific 5-year mortality (HR=1.03, 95% CI 0.89 to 1.19).
Conclusions
No measurable effects of holiday periods on short-term or longer term mortality following surgery for oesophageal cancer were observed in this population-based study, indicating that an adequate surgical experience was maintained during holiday periods.
doi:10.1136/bmjopen-2016-013069
PMCID: PMC5020673  PMID: 27601504
4.  Lymphadenectomy and health-related quality of life after oesophageal cancer surgery: a nationwide, population-based cohort study 
BMJ Open  2016;6(8):e012624.
Objective
The purpose of this study was to clarify whether more extensive surgical lymph node resection during oesophageal cancer surgery influences patients' health-related quality of life (HRQOL).
Setting
This was a nationwide Swedish population-based study.
Participants
A total of 616 patients who underwent curatively intended oesophageal cancer surgery in 2001–2005 were followed up at 6 months and 5 years after surgery.
Outcome measures
HRQOL was assessed with the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) and the oesophageal cancer-specific module (EORTC QLQ-OES18). The number of removed lymph nodes in relation to HRQOL was analysed using multivariable linear regression, providing mean score differences in HRQOL scores with 95% CIs. The results were adjusted for age, comorbidity, body mass index, tumour stage, tumour histology, postoperative complications and surgeon volume.
Results
The study included 382 and 136 patients who completed the EORTC questionnaires at 6 months and 5 years following surgery, respectively. In general, HRQOL remained stable over time, with only improvements in role function and appetite loss. A larger number of removed lymph nodes did not decrease the HRQOL measure at 6 months or 5 years after surgery.
Conclusions
More extensive lymphadenectomy during oesophageal cancer surgery might not decrease patients' short-term or long-term HRQOL, but larger studies are needed to establish this potential lack of association.
doi:10.1136/bmjopen-2016-012624
PMCID: PMC5013438  PMID: 27566643
Lymph node; oesophageal neoplasm; HRQOL
5.  Weekday of oesophageal cancer surgery in relation to early postoperative outcomes in a nationwide Swedish cohort study 
BMJ Open  2016;6(5):e011097.
Objectives
Later weekday of surgery for oesophageal cancer seems to increase 5-year mortality, but the mechanisms are unclear. We hypothesised that early postoperative reoperations and mortality might explain this association, since reoperation after oesophagectomy decreases long-term prognosis, and later weekday of elective surgery increases 30-day mortality.
Design
This was a population-based cohort study during the study period 1987–2014.
Setting
All Swedish hospitals conducting elective surgery for oesophageal cancer in Sweden.
Participants
Included were 1748 patients, representing almost all (98%) patients who underwent elective surgery for oesophageal cancer in Sweden during 1987–2010, with follow-up until 2014.
Primary and secondary outcome measures
The risk of reoperation or mortality within 30 days of oesophageal cancer surgery was assessed in relation to weekday of surgery by calculating ORs with 95% CIs using multivariable logistic regression. ORs were adjusted for age, comorbidity, tumour stage, histology, neoadjuvant therapy and surgeon volume.
Results
Surgery Wednesday to Friday did not increase the risk of reoperation or mortality compared with surgery Monday to Tuesday (OR=0.99, 95% CI 0.75 to 1.31). A decreased point estimate of reoperation (OR=0.88, 95% CI 0.64 to 1.21) was counteracted by an increased point estimate of mortality (OR=1.28, 95% CI 0.83 to 1.99). ORs did not increase from Monday to Friday when each weekday was analysed separately. There was no association between weekday of surgery and reoperation specifically for anastomotic leak, laparotomy or wound infection. Stratification for surgeon volume did not reveal any clear associations between weekday of surgery and risk of 30-day reoperation or mortality.
Conclusions
Weekday of oesophageal cancer surgery does not seem to influence the risk of reoperation or mortality within 30 days of surgery, and thus cannot explain the association between weekday of surgery and long-term prognosis.
doi:10.1136/bmjopen-2016-011097
PMCID: PMC4893871  PMID: 27246001
Oesophageal neoplasm; Day of surgery; Short-term outcomes; Postoperative reoperation; 30-day mortality
6.  Marital status and survival after oesophageal cancer surgery: a population-based nationwide cohort study in Sweden 
BMJ Open  2014;4(6):e005418.
Objectives
A beneficial effect of being married on survival has been shown for several cancer types, but is unclear for oesophageal cancer. The objective of this study was to clarify the potential influence of the marital status on the overall and disease-specific survival after curatively intended treatment of oesophageal cancer using a nationwide population-based design, taking into account the known major prognostic variables.
Design
Prospective, population-based cohort.
Setting
All Swedish hospitals performing surgery for oesophageal cancer during 2001–2005.
Participants
This study included 90% of all patients with oesophageal or junctional cancer who underwent surgical resection in Sweden in 2001–2005, with follow-up until death or the end of the study period (2012).
Primary and secondary outcome measures
Cox regression was used to estimate associations between the marital status and the 5-year overall and disease-specific mortality, expressed as HRs with 95% CIs, with adjustment for sex, age, tumour stage, histological type, complications, comorbidities and annual surgeon volume.
Results
Of all 606 included patients (80.4% men), 55.1% were married, 9.2% were remarried, 22.6% were previously married and 13% were never married. Compared with the married patients, the never married (HR 1.02, 95% CI 0.77 to 1.35), previously married (HR 0.90, 95% CI 0.71 to 1.15) and remarried patients (HR 0.79, 95% CI 0.55 to 1.13) had no increased overall 5-year mortality. The corresponding HRs for disease-specific survival, and after excluding the initial 90 days of surgery, were similar to the HRs for the overall survival.
Conclusions
This study showed no evidence of a better 5-year survival in married patients compared with non-married patients undergoing surgery for oesophageal cancer.
doi:10.1136/bmjopen-2014-005418
PMCID: PMC4054621  PMID: 24907248
Oesophageal Cancer; Marital Status; Survival
7.  Reoperation after oesophageal cancer surgery in relation to long-term survival: a population-based cohort study 
BMJ Open  2014;4(3):e004648.
Objectives
The influence of reoperation on long-term prognosis is unknown. In this large population-based cohort study, it was aimed to investigate the influence of a reoperation within 30 days of oesophageal cancer resection on survival even after excluding the initial postoperative period.
Design
This was a nationwide population-based retrospective cohort study.
Setting
All hospitals performing oesophageal cancer resections during the study period (1987–2010) in Sweden.
Participants
Patients operated for oesophageal cancer with curative intent in 1987–2010.
Primary and secondary outcomes
Adjusted HRs of all cause, early and late mortality up to 5 years after reoperation following oesophageal cancer resection.
Results
Among 1822 included patients, the 200 (11%) who were reoperated had a 27% increased HR of all-cause mortality (adjusted HR 1.27, 95% CI 1.05 to 1.53) and 28% increased HR of disease-specific mortality (adjusted HR 1.28, 95% CI 1.04 to 1.59), compared to those not reoperated. Reoperation for anastomotic insufficiency in particular was followed by an increased mortality (adjusted HR 1.82, 95% CI 1.19 to 2.76).
Conclusions
This large and population-based nationwide cohort study shows that reoperation within 30 days after primary oesophageal resection was associated with increased mortality, even after excluding the initial 3 months after surgery. This finding stresses the need to consider any actions that might prevent complications and reoperation after oesophageal cancer resection.
doi:10.1136/bmjopen-2013-004648
PMCID: PMC3963069  PMID: 24650808
Surgery
8.  Education level and survival after oesophageal cancer surgery: a prospective population-based cohort study 
BMJ Open  2013;3(12):e003754.
Objectives
This study aimed to investigate whether a higher education level is associated with an improved long-term survival after oesophagectomy for cancer.
Design
A prospective, population-based cohort study.
Setting
Sweden—nationwide.
Participants
90% of all patients with oesophageal and cardia cancer who underwent a resection in Sweden in 2001–2005 were enrolled in this study (N=600; 80.3% male) and followed up until death or the end of the study period (2012). The study exposure was level of education, defined as compulsory (≤9 years), moderate (10–12 years) or high (≥13 years).
Outcome measures
The main outcome measure was overall 5-year survival after oesophagectomy. Cox regression was used to estimate the associations between education level and mortality, expressed as HRs with 95% CIs, with adjustment for sex, age, tumour stage, histological type, complications, comorbidities and annual surgeon volume. The patient group with highest education was used as the reference category.
Results
Among the 600 included patients, 281 (46.8%) had compulsory education, 238 (39.7%) had moderate education and 81 (13.5%) had high education. The overall 5-year survival rate was 23.1%, 24.4% and 32.1% among patients with compulsory, moderate and high education, respectively. After adjustment for confounders, a slightly higher, yet not statistically significantly increased point HR was found among the compulsory educated patients (HR 1.08, 95% CI 0.80 to 1.47). In patients with tumour stage IV, increased adjusted HRs were found for compulsory (HR 2.88, 95% CI 1.07 to 7.73) and moderately (HR 2.83, 95% CI 1.15 to 6.95) educated patients. No statistically significant associations were found for the other tumour stages.
Conclusions
This study provides limited evidence of an association between lower education and worse long-term survival after oesophagectomy for cancer.
doi:10.1136/bmjopen-2013-003754
PMCID: PMC3855588  PMID: 24302504
9.  Clinical implementation of a new antibiotic prophylaxis regimen for percutaneous endoscopic gastrostomy 
BMJ Open  2013;3(5):e003067.
Objectives
This study was undertaken to test the extent to which a new antibiotic prophylaxis regimen for percutaneous endoscopic gastrostomy (PEG), identified as a justified and simpler alternative to conventional regimen in a randomised clinical trial, has been adopted in clinical practice.
Design
A Swedish nationwide implementation survey, conducted in February 2013, assessed the level of clinical implementation of a 20 ml dose of oral solution of sulfamethoxazole and trimethoprim deposited in the PEG catheter immediately after insertion. All hospitals inserting at least five PEGs annually were identified from the Swedish Patient Registry. A clinician involved in the PEG insertions at each hospital participated in a structured telephone interview addressing their routine use of antibiotic prophylaxis.
Setting
All Swedish hospitals inserting PEGs (n=60).
Participants
Representatives of PEG insertions at each of the 60 eligible hospitals participated (100% participation).
Main outcome measures
Use of routine antibiotic prophylaxis for PEG.
Results
A total of 32 (53%) of the 60 hospitals had adopted the new regimen. It was more frequently adopted in university hospitals (67%) than in community hospitals (41%). An annual total of 1813 (70%) of 2573 patients received the new regimen. Higher annual hospital volume was associated with a higher level of adoption of the new regimen (80% in the highest vs 31% in the lowest).
Conclusions
The clinical implementation of the new antibiotic prophylaxis regimen for PEG was high and rapid (70% of all patients within 3 years), particularly in large hospitals.
doi:10.1136/bmjopen-2013-003067
PMCID: PMC3668416  PMID: 23793708
NUTRITION & DIETETICS; SURGERY
10.  Number and burden of cardiovascular diseases in relation to health-related quality of life in a cross-sectional population-based cohort study 
BMJ Open  2012;2(5):e001554.
Objectives
To clarify whether a greater number of cardiovascular diseases or a larger burden of disease are associated with poorer health-related quality of life (HRQoL) in an unselected general population.
Design
A population-based cross-sectional postal survey.
Settings
A random sample of the Swedish general population aged 40–79 years matched for national distributions of age, gender and region.
Participants
Out of 6969 eligible individuals, 4910 (70.5%) participated.
Primary and secondary measures
To create a reference database for HRQoL outcomes in the general population. To assess certain diseases and their relation to HRQoL.
Methods
Predefined cardiovascular diseases and HRQoL were assessed from validated questionnaires (EORTC QLQ-C30). Aspects of HRQoL included in the analyses were global quality of life, physical function, role function, emotional function, fatigue and dyspnoea. Individuals were categorised into: ‘good function’ versus ‘poor function’ and ‘no or minor symptoms’ versus ‘symptomatic’. Multivariable logistic regression calculated OR with 95% CI for poor HRQoL. The exposures were the number of cardiovascular diseases and the subjective disease burden.
Results
Out of the 4910 participants, 1358 (28%) reported having a cardiovascular disease and hypertension was most common. Reporting a greater number of cardiovascular diseases was associated with an increased risk of poor HRQoL, especially regarding dyspnoea. The OR for symptomatic dyspnoea was 1.37 (95% CI 1.08 to 1.74) for participants with one cardiovascular disease, 4.81 (95% CI 3.24 to 7.13) for two diseases and 4.18 (95% CI 2.24 to 7.80) for those with three or more cardiovascular diseases. Among the 271 participants who assessed their cardiovascular disease burden as major, the highest risk for poor HRQoL was found for physical function (OR 6.18, 95% CI 3.72 to 10.30).
Conclusions
Increased number of cardiovascular diseases and a greater burden of disease are generally associated with poorer HRQoL in people with cardiovascular disease from an unselected population.
doi:10.1136/bmjopen-2012-001554
PMCID: PMC3488712  PMID: 23100444
Epidemiology; Health Economics
11.  Patients’ perspectives of living with a percutaneous endoscopic gastrostomy (PEG) 
BMC Gastroenterology  2012;12:126.
Background
Since enteral nutrition therapy is the preferred nutritional support for dysphagic patients with a range of diagnoses, PEG has become part of traditional care. However, enteral nutrition with PEG transfers treatment responsibility and activity to the patients and their carers, so the advantages should be discussed. The aim of this study was therefore to investigate patients’ experience of living with a percutaneous endoscopic gastrostomy (PEG) in order to increase the understanding of patients’ need for support.
Method
In a prospective study at Karolinska University Hospital in Sweden, data were collected consecutively at the time of PEG and two months later using a study-specific questionnaire about each patient’s experience of living with a PEG. Fishers exact test was used to test for statistically significant difference at five per cent level.
Results
There were 104 responders (response rate of 70%). Women felt more limited in daily activity compared to men (p = 0.004). Older patients experienced a more limited ability to influence the number of feeding times compared to younger (p = 0.026). Highly educated patients found feeding more time-consuming (p = 0.004). Patients with a cancer diagnosis reported that the PEG feeding interfered with their oral feeding more than patients with a neurological disease (p = 0.009). Patients mostly contacted the PEG outpatient clinic with problems regarding their PEG, and were mainly assisted by their spouse rather than district nurses.
Conclusions
PEG feeding is time-consuming and interferes with daily life. Although 73% was satisfied, patients’ experiences of living with a PEG may be dependent on age, sex, education and diagnosis. Spouses are the main carers for PEG patients at home, and patients prefer to go to the PEG outpatient clinic for help if problems occur.
doi:10.1186/1471-230X-12-126
PMCID: PMC3503865  PMID: 22989321
Experience; Impact; Nutrition; Support
12.  Physical activity, obesity and gastroesophageal reflux disease in the general population 
AIM: To clarify the association between physical activity and gastroesophageal reflux disease (GERD) in non-obese and obese people.
METHODS: A Swedish population-based cross-sectional survey was conducted. Participants aged 40-79 years were randomly selected from the Swedish Registry of the Total Population. Data on physical activity, GERD, body mass index (BMI) and the covariates age, gender, comorbidity, education, sleeping problems, and tobacco smoking were obtained using validated questionnaires. GERD was self-reported and defined as heartburn or regurgitation at least once weekly, and having at least moderate problems from such symptoms. Frequency of physical activity was categorized into three groups: (1) “high” (several times/week); (2) “intermediate” (approximately once weekly); and (3) “low” (1-3 times/mo or less). Analyses were stratified for participants with “normal weight” (BMI < 25 kg/m2), “overweight” (BMI 25 to ≤ 30 kg/m2) and “obese” (BMI > 30 kg/m2). Multivariate logistic regression was used to calculate odds ratios (ORs) with 95% confidence intervals (CIs), adjusted for potential confounding by covariates.
RESULTS: Of 6969 eligible and randomly selected individuals, 4910 (70.5%) participated. High frequency of physical activity was reported by 2463 (50%) participants, GERD was identified in 472 (10%) participants, and obesity was found in 680 (14%). There were 226 (5%) individuals with missing information about BMI. Normal weight, overweight and obese participants were similar regarding distribution of gender and tobacco smoking status, while obese participants were on average slightly older, had fewer years of education, more comorbidity, slightly more sleeping problems, lower frequency of physical activity, and higher occurrence of GERD. Among the 2146 normal-weight participants, crude point estimates indicated a decreased risk of GERD among individuals with high frequency of physical activity (OR: 0.59, 95% CI: 0.39-0.89), compared to low frequency of physical activity. However, after adjustment for potential confounding factors, neither intermediate (OR: 1.30, 95% CI: 0.75-2.26) nor high (OR: 0.99, 95% CI: 0.62-1.60) frequency of physical activity was followed by decreased risk of GERD. Sleeping problems and high comorbidity were identified as potential confounders. Among the 1859 overweight participants, crude point estimates indicated no increased or decreased risk of GERD among individuals with intermediate or high frequency of physical activity, compared to low frequency. After adjustment for confounding, neither intermediate (OR: 0.75, 95% CI: 0.46-1.22) nor high frequency of physical activity were followed by increased or decreased risk of GERD compared to low frequency among nonobese participants. Sleeping problems and high comorbidity were identified as potential confounders for overweight participants. In obese individuals, crude ORs were similar to the adjusted ORs and no particular confounding factors were identified. Intermediate frequency of physical activity was associated with a decreased occurrence of GERD compared to low frequency of physical activity (adjusted OR: 0.41, 95% CI: 0.22-0.77).
CONCLUSION: Intermediate frequency of physical activity might decrease the risk of GERD among obese individuals, while no influence of physical activity on GERD was found in non-obese people.
doi:10.3748/wjg.v18.i28.3710
PMCID: PMC3406423  PMID: 22851863
Physical exercise; Gastroesophageal reflux disease; Population-based study; Risk factor; Body mass index; Obesity
13.  Novel approach to antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): randomised controlled trial 
Objective To evaluate a new and simpler strategy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG).
Design Single centre, two arm, randomised, controlled, double blind clinical trial.
Setting Endoscopy unit in Karolinska University Hospital, Stockholm, Sweden, between 3 June 2005 and 31 October 2009.
Participants 234 patients with an indication for PEG who gave informed consent to participate.
Intervention A single 20 ml dose of the oral solution of sulfamethoxazole and trimethoprim (also known as co-trimoxazole or Bactrim; F Hoffmann-La Roche Ltd, Basel, Switzerland) deposited in the PEG catheter immediately after insertion. The control group received standard prophylaxis consisting of a single intravenous dose of 1.5 g cefuroxime (Zinacef; GlaxoSmithKline, London) administered before insertion of the PEG tube.
Main outcome measure Primary outcome was the occurrence of clinically evident wound infection within 14 days after insertion of the PEG catheter. Secondary outcomes were positive bacterial culture and blood tests (highly sensitive C reactive protein and white blood cell count). All randomised patients were included in an intention to treat analysis.
Results Of the 234 patients included in this study, 116 were randomly assigned to co-trimoxazole and 118 to cefuroxime. At follow-up 7-14 days after insertion of the PEG catheter, wound infection was found in 10 (8.6%) patients in the co-trimoxazole group and 14 (11.9%) in the cefuroxime group, which corresponds to a percentage point difference of −3.3% (95% confidence interval −10.9% to 4.5%). The per protocol analysis, which comprised 100 patients in each group, gave similar results—10% and 13% infection in the co-trimoxazole and cefuroxime groups, respectively (percentage point difference −3.0%, 95% CI −11.8% to 5.8%). Both these analyses indicate non-inferiority of co-trimoxazole compared with cefuroxime because the upper bounds of the confidence intervals are lower than the pre-determined non-inferiority margin of 15%. Analyses of the secondary outcomes supported this finding.
Conclusion 20 ml of co-trimoxazole solution deposited in a newly inserted PEG catheter is at least as effective as cefuroxime prophylaxis given intravenously before PEG at preventing wound infections in patients undergoing PEG.
Trial registration Current Controlled Trials ISRCTN18677736.
doi:10.1136/bmj.c3115
PMCID: PMC2896486  PMID: 20601414
14.  Novel approach to antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): randomised controlled trial 
The BMJ  2010;341:c3115.
Objective To evaluate a new and simpler strategy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG).
Design Single centre, two arm, randomised, controlled, double blind clinical trial.
Setting Endoscopy unit in Karolinska University Hospital, Stockholm, Sweden, between 3 June 2005 and 31 October 2009.
Participants 234 patients with an indication for PEG who gave informed consent to participate.
Intervention A single 20 ml dose of the oral solution of sulfamethoxazole and trimethoprim (also known as co-trimoxazole or Bactrim; F Hoffmann-La Roche Ltd, Basel, Switzerland) deposited in the PEG catheter immediately after insertion. The control group received standard prophylaxis consisting of a single intravenous dose of 1.5 g cefuroxime (Zinacef; GlaxoSmithKline, London) administered before insertion of the PEG tube.
Main outcome measure Primary outcome was the occurrence of clinically evident wound infection within 14 days after insertion of the PEG catheter. Secondary outcomes were positive bacterial culture and blood tests (highly sensitive C reactive protein and white blood cell count). All randomised patients were included in an intention to treat analysis.
Results Of the 234 patients included in this study, 116 were randomly assigned to co-trimoxazole and 118 to cefuroxime. At follow-up 7-14 days after insertion of the PEG catheter, wound infection was found in 10 (8.6%) patients in the co-trimoxazole group and 14 (11.9%) in the cefuroxime group, which corresponds to a percentage point difference of −3.3% (95% confidence interval −10.9% to 4.5%). The per protocol analysis, which comprised 100 patients in each group, gave similar results—10% and 13% infection in the co-trimoxazole and cefuroxime groups, respectively (percentage point difference −3.0%, 95% CI −11.8% to 5.8%). Both these analyses indicate non-inferiority of co-trimoxazole compared with cefuroxime because the upper bounds of the confidence intervals are lower than the pre-determined non-inferiority margin of 15%. Analyses of the secondary outcomes supported this finding.
Conclusion 20 ml of co-trimoxazole solution deposited in a newly inserted PEG catheter is at least as effective as cefuroxime prophylaxis given intravenously before PEG at preventing wound infections in patients undergoing PEG.
Trial registration Current Controlled Trials ISRCTN18677736.
doi:10.1136/bmj.c3115
PMCID: PMC2896486  PMID: 20601414
15.  Antralization of the Gastric Mucosa of the Incisura Angularis and its Gastrin Expression 
The frequency of antrum-type mucosa and gastrin expression in gastric biopsies from the incisura angularis was assessed in 60 consecutive patients having gastrointestinal symptoms. Following the recommendations from the updated Sydney System for the classification and grading of gastritis, two biopsies were taken from the antrum, one from the incisura and two from the corpus. Sections were stained with H&E, Giemsa and for gastrin. Gastrin-positive cells were semi-quantified as: 0 (none), ≤ 9, 10- 49 cells and ≥50 gastrin-labelled cells/40× field. Antrum-type mucosa at the incisura (called antralization) occurred in 30% of the biopsies without inflammation, but in 69% of those with H. pylori-induced gastritis, and in 64% of those with autoimmune gastritis. At the incisura, gastrin-labelled cells (≥10) were found in 62% (18/29) of biopsies showing antralization, but in only 20% (3/15) of those having transitional-type mucosa (p<0.05) and in none of the 16 biopsies having fundic-type mucosa. The similarity in gastrin expression between the mucosa of the gastric antrum and the antral-type mucosa at the incisura substantiates the notion that antralization is a metaplastic transformation. The significantly higher frequency of antral-type mucosa at the incisura in patients with gastritis than in those without gastritis strongly suggests that chronic inflammation per se triggers antralization of the incisura, irrespective of the presence or absence of H. pylori infection.
PMCID: PMC2491394  PMID: 18830388
Antralization; incisura; gastrin; chronic gastritis

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