9 results
Search Results
2. Short Papers.
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ENDOSCOPIC surgery , *SURGICAL complications , *FUNDOPLICATION , *GASTRECTOMY , *MEDICAL care - Published
- 2018
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3. Three‐field versus two‐field lymphadenectomy in transthoracic oesophagectomy for oesophageal squamous cell carcinoma: short‐term outcomes of a randomized clinical trial.
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Li, B., Hu, H., Zhang, Y., Zhang, J., Miao, L., Ma, L., Luo, X., Ye, T., Li, H., Li, Y., Shen, L., Zhao, K., Fan, M., Zhu, Z., Wang, J., Xu, J., Deng, Y., Lu, Q., Pan, Y., and Liu, S.
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LYMPHADENECTOMY , *SQUAMOUS cell carcinoma , *CLINICAL trials , *ESOPHAGECTOMY , *SURGICAL complications , *SURGICAL pathology - Abstract
Background: The benefit and harm of three‐field lymphadenectomy for oesophageal cancer are still unknown. The aim of this study was to compare overall survival and morbidity and mortality between three‐ and two‐field lymphadenectomy in patients with oesophageal squamous cell carcinoma. Methods: Between March 2013 and November 2016, patients with squamous cell carcinoma of the middle or distal oesophagus were assigned randomly to open oesophagectomy with three‐field (cervical–thoracic–abdominal) or two‐field (thoracic–abdominal) lymphadenectomy. No chemo(radio) therapy was given before surgery. This paper reports on the secondary outcomes of the study: pathology and surgical complications. Results: Some 400 patients were randomized, 200 in each group. A median of 37 (i.q.r. 30–49) lymph nodes were dissected in the three‐field group, compared with 24 (18–30) in the two‐field group (P < 0·001). Some 43 of 200 patients (21·5 per cent) in the three‐field group had cervical lymph node metastasis. More patients in the three‐field group had pN3 disease: 21 of 200 (10·5 per cent) versus 10 of 200 (5·0 per cent) (P = 0·040). The rate and severity of postoperative complications were comparable between the two groups, except that six patients in the three‐field arm needed reintubation compared with none in the two‐field group (3·0 versus 0 per cent; P = 0·030). The 90‐day mortality rate was 0 per cent in the three‐field group and 0·5 per cent (1 patient) in the two‐field group (P = 1·000). Conclusion: Oesophagectomy with three‐field lymphadenectomy increased the number of lymph nodes dissected and led to stage migration owing to a 21·5 per cent rate of cervical lymph node metastasis. Postoperative complications were largely comparable between two‐ and three‐field lymphadenectomy. Registration number: NCT01807936 (https://www.clinicaltrials.gov). [ABSTRACT FROM AUTHOR]
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- 2020
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4. Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice.
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Rogers, C. A., Reeves, B. C., Byrne, J., Donovan, J. L., Mazza, G., Paramasivan, S., Andrews, R. C., Wordsworth, S., Thompson, J., Blazeby, J. M., Welbourn, R., Agrawal, S., Ajaz, S., Koak, Y., Ahmed, A., Fakih, N., Hakky, S., Moorthy, K., Purkayastha, S., and Awad, S.
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RANDOMIZED controlled trials , *SURGICAL complications , *GASTRIC bypass complications , *GASTRIC banding , *BARIATRIC surgery , *GASTRECTOMY - Abstract
Background Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention. Methods The By-Band study was designed in the UK in 2009-2010 to compare the effectiveness of laparoscopic adjustable gastric band and Roux-en- Y gastric bypass for severe obesity. It contained a pilot phase to establish whether recruitment was possible, and the grant proposal specified that an adaptation to include sleeve gastrectomy would be considered if practice changed and recruitment was successful. Information on changing obesity surgery practice, updated evidence and expert opinion about trial design were used to inform the adaptation. Results The pilot phase recruited over 13 months in 2013-2014 and randomized 80 patients (79 anticipated). During this time, major changes in obesity practice in the UK were observed, with gastric band reducing from 32·6 to 15·8 per cent and sleeve gastrectomy increasing from 9·0 to 28·1 per cent. The evidence base had not changed markedly. The British Obesity and Metabolic Surgery Society and study oversight committees supported an adaptation to include sleeve gastrectomy, and a proposal to do so was approved by the funder. Conclusion Adaptation of a two-group surgical RCT can allow evaluation of a third procedure and maintain relevance of the RCT to practice. It also optimizes the use of existing trial infrastructure to answer an additional important research question. Registration number: ISRCTN00786323 (/). [ABSTRACT FROM AUTHOR]
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- 2017
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5. Systematic review of intervention design and delivery in pragmatic and explanatory surgical randomized clinical trials.
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Blencowe, N. S., Boddy, A. P., Harris, A., Hanna, T., Whiting, P., Cook, J. A., and Blazeby, J. M.
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CLINICAL trials , *SURGERY , *PATIENT compliance , *OPERATIVE surgery , *SURGICAL complications - Abstract
Background Surgical interventions are complex, with multiple components that require consideration in trial reporting. This review examines the reporting of details of surgical interventions in randomized clinical trials ( RCTs) within the context of explanatory and pragmatic study designs. Methods Systematic searches identified RCTs of surgical interventions published in 2010 and 2011. Included studies were categorized as predominantly explanatory or pragmatic. The extent of intervention details in the reports were compared with the CONSORT statement for reporting trials of non-pharmacological treatments ( CONSORT-NPT). CONSORT-NPT recommends reporting the descriptions of surgical interventions, whether they were standardized and adhered to (items 4a, 4b and 4c). Reporting of the context of intervention delivery (items 3 and 15) and operator expertise (item 15) were assessed. Results Of 4541 abstracts and 131 full-text articles, 80 were included (of which 39 were classified as predominantly pragmatic), reporting 160 interventions. Descriptions of 129 interventions (80·6 per cent) were provided. Standardization was mentioned for 47 (29·4 per cent) of the 160 interventions, and 22 articles (28 per cent) reported measurement of adherence to at least one aspect of the intervention. Seventy-one papers (89 per cent) provided some information about context. For one-third of interventions (55, 34·4 per cent), some data were provided regarding the expertise of personnel involved. Reporting standards were similar in trials classified as pragmatic or explanatory. Conclusion The lack of detail in trial reports about surgical interventions creates difficulties in understanding which operations were actually evaluated. Methods for designing and reporting surgical interventions in RCTs, contributing to the quality of the overall study design, are required. This should allow better implementation of trial results into practice. [ABSTRACT FROM AUTHOR]
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- 2015
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6. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks.
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McDermott, F. D., Heeney, A., Kelly, M. E., Steele, R. J., Carlson, G. L., and Winter, D. C.
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COLON diseases , *COLON surgery , *SURGICAL complications , *RADIOTHERAPY , *BEVACIZUMAB - Abstract
Background Anastomotic leak ( AL) represents a dreaded complication following colorectal surgery, with a prevalence of 1-19 per cent. There remains a lack of consensus regarding factors that may predispose to AL and the relative risks associated with them. The objective was to perform a systematic review of the literature, focusing on the role of preoperative, intraoperative and postoperative factors in the development of colorectal ALs. Methods A systematic review was performed to identify adjustable and non-adjustable preoperative, intraoperative and postoperative factors in the pathogenesis of AL. Additionally, a severity grading system was proposed to guide treatment. Results Of 1707 papers screened, 451 fulfilled the criteria for inclusion in the review. Significant preoperative risk factors were: male sex, American Society of Anesthesiologists fitness grade above II, renal disease, co-morbidity and history of radiotherapy. Tumour-related factors were: distal site, size larger than 3 cm, advanced stage, emergency surgery and metastatic disease. Adjustable risk factors were: smoking, obesity, poor nutrition, alcohol excess, immunosuppressants and bevacizumab. Intraoperative risk factors were: blood loss/transfusion and duration of surgery more than 4 h. Stomas lessen the consequences but not the prevalence of AL. In the postoperative period, CT is the most commonly used imaging tool, with or without rectal contrast, and a C-reactive protein level exceeding 150 mg/l on day 3-5 is the most sensitive biochemical marker. A five-level classification system for AL severity and appropriate management is presented. Conclusion Specific risk factors and their potential correction or indications for stoma were identified. An AL severity score is proposed to aid clinical decision-making. [ABSTRACT FROM AUTHOR]
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- 2015
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7. Systematic review of surgery and outcomes in patients with primary aldosteronism.
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Muth, A., Ragnarsson, O., Johannsson, G., and Wängberg, B.
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HYPERALDOSTERONISM , *ADRENALECTOMY , *HEALTH outcome assessment , *HYPERTENSION , *SYSTEMATIC reviews , *SURGICAL complications , *THERAPEUTICS - Abstract
Background: Primary aldosteronism (PA) is the most common cause of secondary hypertension. The main aims of this paper were to review outcome after surgical versus medical treatment of PA and partial versus total adrenalectomy in patients with PA. Methods: Relevant medical literature from PubMed, the Cochrane Library and Embase OvidSP from 1985 to June 2014 was reviewed. Results: Of 2036 records, 43 articles were included in the final analysis. Twenty-one addressed surgical versus medical treatment of PA, four considered partial versus total adrenalectomy for unilateral PA, and 18 series reported on surgical outcomes. Owing to the heterogeneity of protocols and reported outcomes, only a qualitative analysis was performed. In six studies, surgical and medical treatment had comparable outcomes concerning blood pressure, whereas six showed better outcome after surgery. No differences were seen in cardiovascular complications, but surgery was associated with the use of fewer antihypertensive medications after surgery, improved quality of life, and (possibly) lower all-cause mortality compared with medical treatment. Randomized studies indicate a role for partial adrenalectomy in PA, but the high rate of multiple adenomas or adenoma combined with hyperplasia in localized disease is disconcerting. Surgery for unilateral dominant PA normalized BP in a mean of 42 (range 20-72) per cent and the biochemical profile in 96-100 per cent of patients. The mean complication rate in 1056 patients was 4·7 per cent. Conclusion: Recommendations for treatment of PA are hampered by the lack of randomized trials, but support surgical resection of unilateral disease. Partial adrenalectomy may be an option in selected patients. [ABSTRACT FROM AUTHOR]
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- 2015
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8. Reduction in emergency surgery activity during COVID‐19 pandemic in three Spanish hospitals.
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Cano‐Valderrama, O., Morales, X., Ferrigni, C. J., Martín‐Antona, E., Turrado, V., García, A., Cuñarro‐López, Y., Zarain‐Obrador, L., Duran‐Poveda, M., Balibrea, J. M., and Torres, A. J.
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COVID-19 pandemic , *SURGICAL emergencies , *REOPERATION , *SURGICAL complications , *APPENDECTOMY , *HOSPITALS - Abstract
In their recent paper, Spinelli and Pellino talked about emergency surgery during the COVID-19 pandemic[1]. A 65-4 per cent decrease in emergency surgery activity was observed; the mean number of patients who underwent emergency surgery daily in each hospital decreased from 2-6 during the control period to 0-9 during pandemic period ( I P i < 0-001). Considering these results, those regions where the COVID-19 pandemic is now developing should assume that emergency surgery activity will decrease to one-third of normal. [Extracted from the article]
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- 2020
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9. Comment on: Performance of a modified three‐level classification in stratifying open liver resection procedures in terms of complexity and postoperative morbidity.
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Lee, M. K. and Strasberg, S. M.
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LIVER , *LIVER surgery , *SURGICAL complications , *CLASSIFICATION , *DISEASES - Abstract
Comment on: Performance of a modified three-level classification in stratifying open liver resection procedures in terms of complexity and postoperative morbidity Kawaguchi I et al i . recently described a three-level classification for stratifying complexity of open liver surgery[1] based on their previously published classification of laparoscopic liver operations[2]. But caudate resection and segmentectomy (Sg) 2/3 resection values are present in the utility method and these fall into the posterosuperior and anterolateral segment groups according to Kawaguchi I et al i .'s original paper[2]. [Extracted from the article]
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- 2020
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