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1.
BMJ Open ; 9(11): e030907, 2019 11 19.
Article in English | MEDLINE | ID: mdl-31748296

ABSTRACT

INTRODUCTION: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. METHODS AND ANALYSIS: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery. ETHICS AND DISSEMINATION: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10386621.


Subject(s)
Adenocarcinoma/surgery , Carcinoma, Squamous Cell/surgery , Esophageal Neoplasms/surgery , Esophagectomy/methods , Laparoscopy , Adenocarcinoma/economics , Adenocarcinoma/mortality , Adolescent , Adult , Aged , Aged, 80 and over , Carcinoma, Squamous Cell/economics , Carcinoma, Squamous Cell/mortality , Clinical Protocols , Cost-Benefit Analysis , Double-Blind Method , Esophageal Neoplasms/economics , Esophageal Neoplasms/mortality , Esophagectomy/economics , Female , Follow-Up Studies , Humans , Laparoscopy/economics , Male , Middle Aged , Neoplasm Recurrence, Local/economics , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/etiology , Neoplasm Recurrence, Local/prevention & control , Postoperative Complications/economics , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Quality of Life , Regression Analysis , Treatment Outcome , United Kingdom/epidemiology , Young Adult
2.
J Gastrointest Surg ; 14(8): 1280-4, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20535578

ABSTRACT

INTRODUCTION: The study aims to evaluate the use of "critical view of safety" (CVS) for the prevention of bile duct injuries during laparoscopic cholecystectomy for acute biliary pathology as an alternative to routine intraoperative cholangiography (IOC). METHODS: A policy of routine CVS to identify biliary anatomy and selective IOC for patients suspected to have common bile duct (CBD) stone was adopted. Receiver operator curves (ROCs) were used to identify cutoff values predicting CBD stones. RESULTS: Four hundred forty-seven consecutive, same admission laparoscopic cholecystectomies performed between August 2004 and July 2007 were reviewed. CVS was achieved in 388 (87%) patients. Where CVS was not possible, the operation was completed open. CBD stones were identified in 22/57 patients who underwent selective IOC. Preoperative liver function and CBD diameter were significantly higher in those with CBD stones (P < .001). ROC curve analysis identified preoperative cutoff values of bilirubin (35 mumol/L), alkaline phosphatase (250 IU/L), alanine aminotransferase (240 IU/L), and a CBD diameter of 10 mm, as predictive of CBD stones. No bile duct injuries occurred in this series. CONCLUSION: In acute biliary pathology, the use of CVS helps clarify the anatomy of Calot's triangle and is a suitable alternative to routine IOC. Selective cholangiography should be employed when preoperative liver function and CBD diameter are above defined thresholds.


Subject(s)
Biliary Tract Diseases/diagnostic imaging , Cholangiography/methods , Cholecystectomy, Laparoscopic/methods , Intraoperative Complications/prevention & control , Safety Management/methods , Acute Disease , Biliary Tract Diseases/surgery , Female , Follow-Up Studies , Humans , Intraoperative Period , Male , Middle Aged , Retrospective Studies
3.
Best Pract Res Clin Gastroenterol ; 18(1): 77-98, 2004 Feb.
Article in English | MEDLINE | ID: mdl-15123086

ABSTRACT

Upper gastrointestinal bleeding (UGIB) is one of the most common medical emergencies and remains a major cause of morbidity and mortality among patients. Although initially employed diagnostically, endoscopy has steadily replaced surgery as a first-line treatment in all but the haemodynamically unstable patient. A vast selection of techniques and devices are now available to the dedicated therapeutic endoscopist, including injection therapy, electrical or thermal coagulation and mechanical banding or clipping. The use of endoscopic ultrasound for targeting treatment is increasing and the development of new technologies, such as capsule endoscopy, is likely to play an important role in future protocols. However, despite numerous randomized controlled trials and meta-analyses comparing the efficacy of different endoscopic interventions, the implementation of obtained results into treatment regimes has so far failed to impact significantly on overall UGIB mortality, which remains stubbornly at 10-14%. Reducing this continues to be one of the main challenges facing the therapeutic endoscopist.


Subject(s)
Endoscopy, Gastrointestinal/methods , Gastrointestinal Hemorrhage/diagnosis , Gastrointestinal Hemorrhage/therapy , Hemostasis, Endoscopic/methods , Clinical Trials as Topic , Electrocoagulation/methods , Female , Hemostasis, Endoscopic/adverse effects , Hemostatic Techniques , Humans , Ligation/methods , Male , Prognosis , Risk Assessment , Severity of Illness Index , Treatment Outcome
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