Understanding the influences on successful quality improvement in emergency general surgery: learning from the RCS Chole-QuIC project.

BACKGROUND: Acute gallstone disease is the highest volume Emergency General Surgical presentation in the UK. Recent data indicate wide variations in the quality of care provided across the country, with national guidance for care delivery not implemented in most UK hospitals. Against this backdrop, the Royal College of Surgeons of England set up a 13-hospital quality improvement collaborative (Chole-QuIC) to support clinical teams to reduce time to surgery for patients with acute gallstone disease requiring emergency cholecystectomy. METHODS: Prospective, mixed-methods process evaluation to answer the following: (1) how was the collaborative delivered by the faculty and received, understood and enacted by the participants; (2) what influenced teams' ability to improve care for patients requiring emergency cholecystectomy? We collected and analysed a range of data including field notes, ethnographic observations of meetings, and project documentation. Analysis was based on the framework approach, informed by Normalisation Process Theory, and involved the creation of comparative case studies based on hospital performance during the project. RESULTS: Chole-QuIC was delivered as planned and was well received and understood by participants. Four hospitals were identified as highly successful, based upon a substantial increase in the number of patients having surgery in line with national guidance. Conversely, four hospitals were identified as challenged, achieving no significant improvement. The comparative analysis indicate that six inter-related influences appeared most associated with improvement: (1) achieving clarity of purpose amongst site leads and key stakeholders; (2) capacity to lead and effective project support; (3) ideas to action; (4) learning from own and others' experience; (5) creating additional capacity to do emergency cholecystectomies; and (6) coordinating/managing the patient pathway. CONCLUSION: Collaborative-based quality improvement is a viable strategy for emergency surgery but success requires the deployment of effective clinical strategies in conjunction with improvement strategies. In particular, achieving clarity of purpose about proposed changes amongst key stakeholders was a vital precursor to improvement, enabling the creation of additional surgical capacity and new pathways to be implemented effectively. Protected time, testing ideas, and the ability to learn quickly from data and experience were associated with greater impact within this cohort.

Variation in laparoscopic anti-reflux surgery across England: a 5-year review.

BACKGROUND: Laparoscopic anti-reflux surgery (LARS) remains central to the management of gastro-oesophageal reflux disease but the scale and variation in provision in England is unknown. The aims of this study were firstly to examine the processes and outcomes of anti-reflux surgery in England and compare them to national guidelines and secondly to explore potential variations in practice nationally and establish peer benchmarks. METHODS: All adult patients who underwent LARSin England during the Financial years FY 2011/2012-FY 2016/2017 were identified in the Surgeon's Workload Outcomes and Research Database (SWORD), which is based on the Hospital Episode Statistics (HES) data warehouse. Outcomes included activity volume, day-case rate, short-stay rate, 2- and 30-day readmission rates and 30-day re-operation rates. Funnel plots were used to identify national variation in practice. RESULTS: In total, 12,086 patients underwent LARS in England during the study period. The operation rate decreased slightly over the study period from 5.2 to 4.6 per 100,000 people. Most outcomes were in line with national guidelines including the conversion rate (0.76%), 30-day re-operation rate (1.43%) and 2- and 30-day readmission rates (1.65 and 8.54%, respectively). The day-case rate was low but increased from 7.4 to 15.1% during the 5-year period. Significant variation was found, particularly in terms of hospital volume, and day-case, short-stay and conversion rates. CONCLUSION: Although overall outcomes are comparable to studies from other countries, there is significant variation in anti-reflux surgery activity and outcomes in England. We recommend that units use these data to drive local quality improvement efforts.

Critical review of the prognostic significance of pathological variables in patients undergoing resection for colorectal liver metastases.

OBJECTIVE: The aim of this study was to identify prognostic factors, particularly pathological variables, that influence disease-free and overall survival following resection for colorectal liver metastases (CRLM). METHODS: Patients undergoing CRLM resection from January 2005 to December 2011 were included. Data analysed included information on demographics, laboratory results, operative findings, histopathological features and survival. RESULTS: A total of 259 patients were included. Of these, 138 (53.3%) patients developed recurrent disease, of which 95 died. The median length of follow-up in the remaining patients was 28 months (range: 12-96 months). There were significant associations between recurrence and higher tumour number (P = 0.002), presence of perineural invasion (P = 0.009) and positive margin (R1) resection (P = 0.002). Multivariate analysis showed all three prognostic factors to be independent predictors of disease-free survival. Significantly poorer overall survival after hepatic resection for CRLM was observed in patients undergoing hemi-hepatectomy or more radical resection (P = 0.021), patients with a higher number of tumours (P = 0.024) and patients with perineural invasion (P < 0.001). Multivariate analysis showed perineural invasion to be the only independent predictor of overall survival. CONCLUSIONS: The presence of perineural invasion, multiple tumours and an R1 margin were associated with recurrent disease. Perineural invasion was also an independent prognostic factor with respect to overall survival.

Outcomes in patients with indeterminate pulmonary nodules undergoing resection for colorectal liver metastases.

OBJECTIVES: This study aimed to assess outcomes in patients who underwent hepatic resection for colorectal liver metastases (CRLM) with subcentimetre indeterminate pulmonary nodules (IPN) and to devise a management pathway for these patients. METHODS: Patients undergoing CRLM resection from January 2006 to December 2010 were included. Survival differences following liver resection in patients with and without IPN were determined. RESULTS: A total of 184 patients were included, 30 of whom had IPN. There were no significant differences between the IPN and non-IPN groups in terms of demographics, surgery and pathological factors. There were no significant differences between patients with and without IPN with respect to disease-free (P= 0.190) and overall (P= 0.710) survival. Fifteen patients with IPN progressed to metastatic lung disease over a median period of 10 months (range: 3-18 months); six of these patients underwent lung resection. Of the remaining 15 patients with IPN, eight showed no IPN progression and subsequent CT scans did not identify IPN in the remaining seven. CONCLUSIONS: Colorectal liver metastases patients with IPN who have resectable disease should be treated with liver resection and should be subject to intensive surveillance post-resection. Although 50% of these patients will progress to develop lung metastases, this does not appear to influence survival following liver resection.

An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer.

OBJECTIVES: This study aimed to investigate G17DT, an immunogen producing neutralizing antibodies against the tumor growth factors amidated and glycine-extended forms of gastrin-17, in the treatment of pancreatic cancer. METHODS: A randomized, double-blind, placebo-controlled, group-sequential multicenter trial of G17DT in patients with advanced pancreatic cancer unsuitable for or unwilling to take chemotherapy. Inclusion criteria were a Karnofsky performance score of 60 or higher and a life expectancy of more than 2 months. Patients received G17DT or placebo emulsion at weeks 0, 1, 3, 24, and 52. The primary end point was survival, and secondary end points were tolerability, Karnofsky performance. RESULTS: A total of 154 patients were recruited: 79 G17DT and 75 placebo. A final analysis of the intention-to-treat population, using a proportional hazards model, stratifying by disease stage and adjusting for interim analysis, gave a hazard ratio for mortality of 0.75 (95% confidence interval, 0.51-1.10, P = 0.138; G17DT/placebo). A conventional analysis without adjustment for disease stage or interim analysis, censoring for chemotherapy and excluding protocol violators, gave median survival periods of 151 (G17DT) and 82 days (placebo) (log-rank test, P = 0.03).Patients developing anti-G17DT responses (73.8%) survived longer than nonresponders or those on placebo (median survival, 176 vs 63 vs 83; log-rank test, P = 0.003). G17DT was well tolerated.

Scaffolds containing growth factors and extracellular matrix induce hepatocyte proliferation and cell migration in normal and regenerating rat liver.

BACKGROUND & AIMS: Intrahepatic drug delivery from implantable scaffolds is being developed as a strategy to modulate growth and enhance regeneration at the time of liver resection. In this study we examine the effects of scaffolds containing hepatocyte growth factor, epidermal growth factor, fibroblast growth factor 1, fibroblast growth factor 2, and liver-derived extracellular matrix (L-ECM) when implanted into normal and partially hepatectomized rat livers. METHODS: Scaffolds loaded with combinations of growth factors and L-ECM were implanted into normal livers (controls=L-ECM, polymer or sham) and livers following partial hepatectomy (controls=partial hepatectomy or sham). The primary end points were hepatocyte DNA synthesis and liver tissue penetration into scaffolds. Secondary end points included non-parenchymal cell DNA synthesis, liver weight analysis, liver function, and histological characterisation of the peri-implant parenchyma. RESULTS: Four days after implantation in normal livers, there was significantly more hepatocyte proliferation around growth factor scaffolds than controls. Seven days after implantation, there was significantly more tissue penetration into growth factor scaffolds than control scaffolds. ED-1 and desmin positive cells were present in the pores of scaffolds. Two days after partial hepatectomy, there was significantly more hepatocyte proliferation around scaffold implanted livers than after partial hepatectomy alone. CONCLUSIONS: Growth factors and L-ECM accelerated non-parenchymal cell migration into scaffolds and increased hepatocyte and non-parenchymal cell proliferation around them. These results demonstrate the potential for intrahepatic implantation of scaffolds containing growth factors and L-ECM to modulate growth in the normal and regenerating liver.

Long-term outcome of laparoscopic Nissen and laparoscopic Toupet fundoplication for gastroesophageal reflux disease: a prospective, randomized trial.

BACKGROUND: A prospective, randomized trial was performed to evaluate the long-term outcome and patient satisfaction of laparoscopic complete 360 degrees fundoplication compared with partial posterior 270 degrees fundoplication. Partial fundoplication is purported to have fewer side effects with a higher failure rate in controlling gastroesophageal reflux disease (GERD), while complete fundoplication is thought to result in more dysphagia and gas-related symptoms. METHODS: Patients were randomized to either laparoscopic Nissen (LN) or laparoscopic Toupet (LT) fundoplication. Esophageal manometry, 24-h pH studies, a detailed questionnaire, and a visual analog symptom (VAS) score were completed before and after surgery. A final global outcome questionnaire was performed. Failure was defined as recurrent GERD requiring revision surgery, maintenance proton pump inhibitor (PPI) therapy, or surgery for postoperative dysphagia. RESULTS: One hundred patients were randomized to LN (50) or LT (50). There were no differences between LN and LT with respect to postoperative symptoms and physiological variables except a higher wrap pressure in the LN group (15.2 vs. 12.0 mmHg). Dysmotility improved in 8/14 (57%) and 6/11 (54%) patients in the LN group and the LT group, respectively, after surgery. There was no correlation between dysmotility and dysphagia both pre- and post surgery in the two groups. Recurrent symptoms of GERD occurred in 8/47 (17.0%) and 8/48 (16.6%) in the LN group and the LT group, respectively. Outcome of patients with dysmotility was similar to those with normal motility in both groups. At final follow-up (59.76 + or - 24.23 months), in the LN group, 33/37 (89.1%) would recommend surgery to others, 32/37 (86.4%) would have repeat surgery, and 34/37 (91.8%) felt they were better off than before surgery. The corresponding numbers for the LT group (follow-up = 55.18 + or - 25.97 months) were 35/36 (97.2%), 30/36 (83.3%), and 33/36 (91.6%). CONCLUSION: LN and LT are equally effective in restoring the lower esophageal sphincter function and provide similar long-term control of GERD with no difference in dysphagia. Esophageal dysmotility had no influence on the outcome of either operation.

Is a T-tube necessary after common bile duct exploration?

BACKGROUND: T-tube drainage used to be standard practice after surgical choledocholithotomy, but there is now a tendency in some centers to close the common bile duct (CBD) primarily. This study was designed to review the complications associated with T-tube drainage after CBD exploration and to determine whether primary closure of the bile duct reduces postoperative morbidity. METHODS: A retrospective audit was performed on patients undergoing CBD exploration between July 1997 and March 2007, who were identified from the theatre database of one teaching hospital. Intraoperative findings and postoperative complications were recorded from the clinical notes. RESULTS: During the study period, 158 patients (97 women; median age 65 (range, 25-90) years) underwent CBD exploration. A T-tube was inserted in 91 patients (group I) and the CBD was closed primarily in 67 (group II). One or more biliary complications occurred in 26 patients (16.5%): 20 (22.0%) in group I and 6 (8.9%) in group II (p = 0.03). In group I, 15 had a biliary leak (3 needed reoperation), 2 had accidental slippage of the tube, 2 an entrapped T-tube, and 1 a retained stone. In group II, six patients had biliary leakage, two of whom were re-explored. Six patients in group I also had peritubal infection, necessitating the use of antibiotics. There were three deaths: two in group I (1 T-tube-related) and 1 in group II (p = 1, not significant). CONCLUSION: There is a lower biliary complication rate associated with primary closure of the CBD than after T-tube drainage.

The pathological response to neoadjuvant chemotherapy with FOLFOX-4 for colorectal liver metastases: a comparative study.

FOLFOX-4 (folinic acid/5-fluorouracil/oxaliplatin) chemotherapy is used to treat patients with colorectal liver metastases. We aimed to assess hepatic histopathological responses to neoadjuvant FOLFOX-4 chemotherapy in patients with colorectal liver metastases. We selected all patients (n = 54) treated with FOLFOX-4 for colorectal liver metastases between June 2002 and June 2005. Only 25 underwent hepatectomy and formed the study group. Histological responses were assessed in the study group and a matched control group (n = 25) that did not receive neoadjuvant chemotherapy. The median (IQR) body mass index in the study and control groups was 24 (22-26) and 24 (23-25) kg/m(2), respectively, (P = NS). Complete histological resolution of tumour occurred in six (24%) patients in the study group. Median residual tumour cellularity was less (35 vs 70%) and fibrosis greater (50 vs 5%) in patients in the study group when compared with controls (P < 0.001). The liver surrounding the tumour was steatotic in 17 (68%) patients in the study group and five (20%) controls (P = 0.001). Hepatic sinusoidal dilatation was more pronounced in patients in the study group than in controls (P < 0.001). The response to FOLFOX-4 was associated with tumour necrosis, fibrosis and inflammation. More than two thirds of patients undergoing hepatectomy after FOLFOX-4 had steatosis despite being non-obese.

The effect of hepatic vascular inflow occlusion on liver tissue pH, carbon dioxide, and oxygen partial pressures: defining the optimal clamp/release regime for intermittent portal clamping.

BACKGROUND: The optimal duration of hepatic vascular inflow occlusion (Pringle maneuver) and reperfusion during liver resection are not defined. The aim of this study was to describe the changes that occur in liver tissue pH, partial pressure of carbon dioxide (P(L)CO(2)), and partial pressure of oxygen (P(L)O(2)) and by using the P(L)CO(2) as a predictor of hepatocellular damage define the optimal clamp/release regime for intermittent portal clamping during liver resection. METHODS: Continuous pH, P(L)CO(2), and P(L)O(2) measurements were obtained using a Paratrend multi-parameter sensor (Diametrics Medical Inc., Roseville, MN) in 13 patients undergoing elective partial liver resection. Patients were randomly allocated to undergo a 10-min clamp/5-min release regime (group 1) or a 20-min clamp/10-min release regime (group 2). RESULTS: In group 1 (n = 6) P(L)CO(2) increased and pH decreased significantly after 10 min of clamping and returned to baseline within 5 min of reperfusion. In group 2 (n = 7) the P(L)CO(2) increased and pH decreased significantly after 10 min of clamping, with a further significant change after 20 min. Following 10 min of reperfusion, pH and P(L)CO(2) had not returned to baseline. P(L)O(2) did not change significantly with either intermittent portal clamping regime. CONCLUSIONS: A reperfusion of 5 min is sufficient to restore the P(L)CO(2) and liver tissue pH to normal after 10 min of clamping, but more than 10 min of reperfusion is required after 20 min of clamping. To minimize hepatic ischemia during liver resection, a 10-min clamp/5-min release regime should be used.

The position of the vermiform appendix at laparoscopy.

BACKGROUND: The vermiform appendix has no constant position and the data on the variations in its position are limited. The aim of this study was to determine the frequency of the various positions of the appendix at laparoscopy. METHODS: Patients undergoing emergency or elective laparoscopy at a university teaching hospital between April and September 2004 were studied prospectively. The positions of the appendix and the caecum were determined after insertion of the laparoscope, prior to any other procedure and the relative frequencies calculated. RESULTS: A total of 303 (102 males and 201 females) patients with a median age of 52 years (range 18-93 years) were studied. An emergency appendicectomy was performed in 67 patients, 49 had a diagnostic laparoscopy, 179 underwent a laparoscopic cholecystectomy and eight had other procedures. The caecum was at McBurney's point in 245 (80.9%) patients, pelvic in 45 (14.9%) and high lying in 13 (4.3%). The appendix was pelvic in 155 (51.2%) patients, pre-ileal in 9 (3.0%), para-caecal in 11 (3.6%), post-ileal in 67 (22.1%) and retrocaecal in 61 (20.1%) patients. CONCLUSION: Contrary to the common belief the appendix is more often found in the pelvic rather than the retrocaecal position. There is also considerable variation in the position of the caecum.

A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures.

The aim of this study was to compare the efficacy of n-butyl-cyanoacrylate tissue adhesive (Liquiband) with nonabsorbable monofilament sutures for laparoscopic port site closure. Adult patients having elective laparoscopic procedures were randomly allocated to wound closure with sutures or tissue adhesive. End points included skin closure time, wound dressing requirements, wound complications, and cosmesis, assessed at discharge, 4 to 6 weeks and 3 months. Seventy-eight patients randomized to receive sutures and 76 to receive tissue adhesive were eligible for final analysis. Mean closure time was significantly longer for sutures (220 vs. 125 s, P < 0.001). Fewer dressings were required in the tissue adhesive group immediately postoperatively (21% vs. 97%, P < 0.001) and at discharge (24% vs. 82%, P < 0.001). There were no significant differences in wound complications or in cosmesis at either 4 to 6 weeks or at 3 months. Tissue adhesive for laparoscopic port site closure offers potential savings with respect to time and has comparable wound complication rates and cosmetic outcomes when compared with nonabsorbable monofilament sutures.

Scaffolds for liver tissue engineering.

This review focuses on the expanding role for biomaterials and polymer scaffolds in liver tissue engineering. Studies are subdivided into in vitro and in vivo approaches. The in vitro section of the review discusses the challenges specific to liver tissue engineering, and how the choice of scaffold and its structure influences the success of the regenerative medicine strategy. The in vivo section evaluates early attempts to stimulate liver repair with cell and growth factor therapies, their failings and how current approaches aim to solve these problems.

Percutaneous biliary metal wall stenting in malignant obstructive jaundice.

BACKGROUND: Most patients with advanced stage malignant obstructive jaundice will be suitable for palliation only. Metallic stents are safe, effective and minimally invasive. DESIGN: A review of case notes of patients who had Wallstents inserted percutaneously from January 1996 to December 2000. RESULTS: Eighty-nine patients with a median age of 72 years underwent percutaneous insertion of biliary metal stents. The diagnoses were cholangiocarcinoma (41.5%), pancreatic carcinoma (40.5%), nodal metastases at the porta hepatis (14.6%) and gall bladder cancer (3.4%). Ninety-six per cent of patients improved their hyperbilirubinaemia to normal levels by 1 month. The median post-procedure hospital stay was 16 days. Early overall complications (within 30 days of stenting) occurred in 30% of patients (70% of these were disease related). The 30 day mortality rate was 20% (n = 18). Fifty (70%) patients were readmitted to hospital, most commonly because of carcinomatosis (16) or stent obstruction (12). The symptom-free period ranged from 2 weeks to 13 months. Median survival for all patients was 3.5 months. Survival correlated inversely with serum bilirubin at presentation (r = -0.34, P = 0.001), but not with other liver function tests. DISCUSSION: Metal wall stenting for malignant obstructive jaundice provides good palliation with low, procedure-related morbidity and mortality, but poor overall survival from disease-related morbidity. Survival significantly correlates with pre-stenting serum bilirubin levels. There is a need to identify the subgroup of patients in whom stenting has no beneficial effect.

Magnetic resonance cholangiopancreatography versus endoscopic retrograde cholangiopancreatography in the diagnosis of choledocholithiasis.

OBJECTIVE: Endoscopic retrograde cholangiopancreatography (ERCP) has become established as the gold standard in imaging of the biliary tree. Recently, magnetic resonance cholangiopancreatography (MRCP) has been introduced as a new, non-invasive imaging modality for the detection of bile-duct stones and other pathology related to the biliary tract and pancreas. The aim of this study was to determine how MRCP compared with ERCP in the diagnosis of choledocholithiasis. DESIGN AND METHODS: A prospective study of 133 patients referred for either ERCP or MRCP was carried out to compare the results of both these methods in determining the presence of choledocholithiasis. RESULTS: 18 patients were excluded from the analysis: ERCP was unsuccessful in eight of these patients and MRCP was not possible in the remaining 10 patients. There were six false negative results with MRCP; in five of these the calculi were less than 5 mm in diameter. MRCP showed a sensitivity of 84%, specificity of 96%, positive predictive value of 91%, negative predictive value of 93% and diagnostic accuracy of 92% when compared to ERCP as the gold standard. CONCLUSIONS: MRCP has high sensitivity and high specificity for stones greater than 5 mm in diameter and should be performed in preference to ERCP as the first-line investigation in patients with gallstones and abnormal liver function tests in the elective setting. Adoption of this guideline at our institution would result in a 9% reduction in the number of ERCPs performed.