Title: Evidence-based liver pancreas gallbladder (HPB) and general surgery
Funder: Department of Health (England)

Abstract: 6. Details of proposed programme Background (1000 characters max):Surgical practice is based on traditions many of which have no scientific basis. Hepato-pancreato-biliary (HPB) surgical practice is no different. In addition new interventions may be introduced to clinical practice without evidence of patient benefit or cost-effectiveness. HPB procedures (which correspond to the chapter GA GB and GC of HRG4) account for approximately £0.45 billion annually (3.5% of the £13.1 billions spent annually by NHS on inpatient procedures). The HPB surgeon needs a quick and authoritative resource on which to base important clinical decisions. Such a database needs to be up to date easy to access with information delivered in simple language. The Cochrane Database of Systematic Reviews and the Cochrane Database of Diagnostic Reviews satisfy all these criteria. Cochrane reviews provide the best level of evidence that is available. The main Cochrane groups associated with HPB surgical practice are the Cochrane Hepato-Biliary Group (CHBG) and the Cochrane Upper Gastro-Intestinal and Pancreatic Diseases Group (UGPD). The main Cochrane group related to surgical wound related issues is the Cochrane Wounds Group. Unfortunately there are many areas of HPB and general surgical practice where studies have been performed but systematic reviews have not been carried out to clarify the optimal management of patients.This programme will address areas which have not been reviewed or in which updates are required. As a result practising surgeons will be able to make better informed clinical decisions patients will have access to advice on treatment options (described in lay terms) and health care providers will be able to ensure cost effectiveness. Theme and scope of proposed programme (1000 characters max):Theme: Hepato-Pancreato-Biliary and General SurgeryScope: The evidence for surgery or alternative treatments for the following: (a) Surgical training (b) Patient education related to surgical procedures (c) Gallstones and gallstone related illnesses; (d) Other gallbladder disorders such as gallbladder polyp gallbladder dyskinesia (e) Removal of gallbladder (cholecystectomy); (f) Liver cancers and non-cancerous liver tumours; (g) Liver resection (removal of part of liver); (h) Liver transplantation; (i) Pancreatic cancers and non-cancerous pancreatic tumours (j) Inflammation of pancreas (pancreatitis); (k) Abdominal closure methods (l) Assessment of surgical risk for patients; (m) Wound dressings; and (n) Wound infections.Proposed reviews to be undertaken and/or updated and how the choice is justified in terms of NHS priorities (2000 characters max):Review topics have been chosen as they fall under one or more of the following categories: common life threatening or expensive to treat. Surgical training (virtual reality trainer; box trainer; mental training): 3 reviews; Multimedia for patient education related to surgical procedures; Comparison of methods to predict mortality in non-cardiac surgery; Laparoscopic cholecystectomy: Optimal surgical technique of laparoscopic cholecystectomy; Day-case laparoscopic cholecystectomy: safety and effectiveness; anaesthetic regimens; local anaesthetic intra-abdominal and/or wound infiltration; pharmacological interventions to decrease pain and nausea: 6 reviews; Timing of laparoscopic cholecystectomy in acute cholecystitis and acute pancreatitis: 2 reviews; Imaging modalities in diagnosis of common bile duct stones; Robotic versus human assisted laparoscopic cholecystectomy; Biliary tract cancer: Imaging modalities for gallbladder polyps; Liver transplantation: interventions to decrease ischaemia-reperfusion injury; Surgical techniques to improve outcomes after liver transplantation; Staging investigations for liver transplantation carried out for early primary liver cancer: 3 reviews; Liver cancer: Imaging modalities and biochemical markers in serum for differentiating benign and malignant liver cysts; pre-operative staging to assess resectability of colorectal liver metastases; peri-operative chemotherapy in resection of colorectal liver metastases; methods to decrease ischaemia-reperfusion injury in liver resection; methods to decrease blood transfusion requirements during liver resection: 6 reviews. Pancreatic/periampullary cancer: Imaging modalities and biochemical markers for differentiating benign and malignant pancreatic cysts/ biliary strictures; stenting versus surgery for palliation of malignant gastric outlet obstruction; pre-operative staging modalities; resection versus chemoradiotherapy for locally advanced cancer; prophylactic gastrojejunostomy in patients with inoperable pancreatic cancer: 8 reviews; Pancreatitis: Diagnostic tests in the prediction of severity of pancreatitis; Dressing/ Wound: (early removal; early bathing): 2 reviews; Methicillin resistant Staphylococcus aureus (MRSA): prevention and treatment of MRSA in surgical wounds: 2 reviews; Methods of abdominal wound closure: 4 reviews. Further justification of choice: Please see answer to question 10.Outline plan and timetable for undertaking reviews including how award would be used (eg. employment of new researchers) (2000 characters max):All the reviews will be completed in 3 years. Dr K Gurusamy will spend half FTE (full time equivalent) for the systematic review purpose. Another junior doctor will spend approximately half FTE to provide research assistance. An economics researcher will be employed half FTE (full time equivalent) for the health economics stream of this project undertaking 6 full economic evaluations. An editorial assistant (for secretarial and administrative support) will be appointed 0.25 FTE to facilitate the editorial process during the process of the review. Editorial support (Prof B Davidson Prof N Cullum Ms J Lilleyman) and statistical support (Dr E Brunner) will be provided by experienced Cochrane editors. Additional advice will be provided by Prof A Burroughs a co-author of the text book Evidence-Based Gastroenterology. Supervision of the health economist will be provided by Prof S Morris. The remaining funds will be used for obtaining the full texts computers printers scanners software for optical character recognition printing consumables paying the patient representative travel and subsistence charges for three monthly meetings and travel and subsistence charges for conference presentations.Plan and timetable for systematic review stream: The first draft of all the protocols will be completed and submitted for the editorial process by the first 3 months. While comments are received on the protocols updates of outdated reviews and published protocols (for which the reviews have not been completed) will be undertaken for the next 6 months. It is expected that the peer reviewer comments on the protocol would have been received by this time. These comments will be addressed and the protocols revised to secure publication of all the protocols in another 3 months. By the12-month landmark all the protocols will be ready for publication and the updates of all the existing reviews will be completed. In the next 18 months the first draft of the reviews will be submitted. The reviews will be submitted for editorial process as the first draft is completed and it is expected that a significant proportion of the reviews will be ready for publication and the first draft of all the reviews will be completed by the 30-month landmark. During the next 6 months the replies to peer reviewer comments and editorial comments will be completed ensuring that all the reviews are ready for publication.Plan and timetable for health economics stream: The cost-effectiveness analyses will be undertaken in close discussion with the clinicians involved in this project. The health economist will calculate the incremental cost per quality adjusted life year (QALY) gained of 6 high priority interventions (or diagnostic methods) using appropriate economic modelling techniques and methods recommended by National Institute for Health and Clinical Excellence (NICE) for technology appraisals. The economist will identify and collect data on model parameters not collected as part of the main review. Since all the first drafts of the Cochrane reviews will be completed by the 30-month landmark it is expected that first draft of all the health economics reports will be complete by 33 months (by this time a significant proportion of the health economics reports will be completed) allowing 3 months for the completion of the remaining of the final health economics reports.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS;ORAL AND GASTROINTESTINAL