Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study.

BACKGROUND: Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI). PATIENTS/METHODS: The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization. RESULTS: Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers. CONCLUSIONS: The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.

Dobutamine stress echocardiography resulting in acute gastric dilatation and pneumoporta.

Acute gastric dilatation is a rare cause of gas within the hepatic portal vein, but one that is important to recognise as prompt decompression via a nasogastric tube is usually successful in resolving the situation. We report the rare case of a 68-year-old man with spontaneous acute gastric dilatation 50 minutes after a dobutamine stress echo that resulted in pneumoporta. The patient had a Nissen's fundoplication 18 months previously; patients with previous antireflux surgery or who have a degree of gastric outlet obstruction may be at increased risk of this unusual condition. Conservative management, with placement of a nasogastric tube was successful in resolving his symptoms.

Metachronous small bowel metastasis from a mixed Müllerian mesodermal tumour.

A mixed Müllerian mesodermal tumour (MMMT) is a rare aggressive carcinosarcoma. Metastatic progression is uncommon, and occurs via haematological, lymphatic and intraperitoneal spread. Although the latter is seen most frequently, the small intestine seems to be relatively preserved from disease progression with only one reported case of synchronous involvement. We report a case of metachronous MMMT involvement of the small bowel presenting with subacute obstruction that was successfully resected at operation.

Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study.

Outcome reporting in bariatric surgery needs a core outcome set (COS), an agreed minimum set of outcomes reported in all studies of a particular condition. The aim of this study was to summarize outcome reporting in bariatric surgery to inform the development of a COS. Outcomes reported in randomized controlled trials (RCTs) and large non-randomized studies identified by a systematic review were listed verbatim and categorized into domains, scrutinizing the frequency of outcome reporting and uniformity of definitions. Ninety studies (39 RCTs) identified 1,088 separate outcomes, grouped into nine domains with most (n = 920, 85%) reported only once. The largest outcome domain was 'surgical complications', and overall, 42% of outcomes corresponded to a theme of 'adverse events'. Only a quarter of outcomes were defined, and where provided definitions, which were often contradictory. Percentage of excess weight loss was the main study outcome in 49 studies, but nearly 40% of weight loss outcomes were heterogeneous, thus not comparable. Outcomes of diverse bariatric operations focus largely on adverse events. Reporting is inconsistent and ill-defined, limiting interpretation and comparison of published studies. Thus, we propose and are developing a COS for the surgical treatment of severe and complex obesity.

Prospective randomized trial of laparoscopic (transabdominal preperitoneal-TAPP) versus open (mesh) repair for bilateral and recurrent inguinal hernia: incidence of chronic groin pain and impact on quality of life: results of 10 year follow-up.

PURPOSE: The incidence of chronic groin pain (CGP) and its impact on quality of life (QoL) after hernia repair are not clear with follow-up either being short or retrospective. We present 10-year prospective follow-up of a randomized trial for bilateral and recurrent hernia repair focusing on CGP and its impact on QoL. METHODS: Patients enrolled between 1997 and 2000 were contacted by telephone and asked about the presence of CGP. Those patients with CGP were sent two validated questionnaires: a SF-12v2 Health Survey and a Pain Impact Questionnaire (PIQ-6) (QualityMetric, USA). RESULTS: One hundred and twenty patients were recruited into the original study, and of these, 14 complained of CGP and were sent a PIQ-6 and a SF-12 v2 health survey. Overall, there was a higher incidence of CGP in the laparoscopic group compared with the open group (15 vs. 8 %, ns), but the severity of the pain in the laparoscopic group was less (2 vs. 3.5, p = 0.0558). QoL was significantly reduced in patients with CGP compared with the US norm. The laparoscopic group scored higher in 5 out of 8 of the QoL categories compared with the open group, but this was not significant. Overall age-adjusted scores revealed those under 65 years of age felt they had poorer physical health, and this reduced their QoL compared to normal values. CONCLUSION: CGP following laparoscopic surgery for inguinal hernia repair is less severe than open repair, but this does not translate into a significant improvement in QoLin this study.

Effect of the definition of type II diabetes remission in the evaluation of bariatric surgery for metabolic disorders.

BACKGROUND: The American Diabetes Association recently defined remission of type II diabetes as a return to normal measures of glucose metabolism (haemoglobin (Hb) A1c below 6 per cent, fasting glucose less than 5·6 mmol/l) at least 1 year after bariatric surgery without hypoglycaemic medication. A previously used common definition was: being off diabetes medication with normal fasting blood glucose level or HbA1c below 6 per cent. This study evaluated the proportion of patients achieving complete remission of type II diabetes following bariatric surgery according to these definitions. METHODS: This was a retrospective review of data collected prospectively in three bariatric centres on patients undergoing gastric bypass, sleeve gastrectomy and gastric banding. RESULTS: Some 1006 patients underwent surgery, of whom 209 had type II diabetes. Median follow-up was 23 (range 12-75) months. HbA1c was reduced after operation in all three surgical groups (P < 0·001). A total of 72 (34·4 per cent) of 209 patients had complete remission of diabetes, according to the new definition; the remission rates were 40·6 per cent (65 of 160) after gastric bypass, 26 per cent (5 of 19) after sleeve gastrectomy and 7 per cent (2 of 30) after gastric banding (P < 0·001 between groups). The remission rate for gastric bypass was significantly lower with the new definition than with the previously used definition (40·6 versus 57·5 per cent; P = 0·003). CONCLUSION: Expectations of patients and clinicians may have to be adjusted as regards remission of type II diabetes after bariatric surgery. Focusing on improved glycaemic control rather than remission may better reflect the benefit of this type of surgery and facilitate improved glycaemic control after surgery.

Postprandial plasma bile acid responses in normal weight and obese subjects.

BACKGROUND: Bile acids can act as signalling molecules via various receptors including the nuclear farnesoid X receptor (FXR) and pregnane X receptor (PXR), and the cell surface G-protein-coupled receptor TGR5. The signalling has been implicated in the release of peptide YY (PYY) and glucagon-like peptide 1 (GLP-1), which improves glycaemic control and energy expenditure. We investigated whether morbidly obese subjects have altered postprandial bile acid responses in comparison to normal weight subjects. METHOD: Blood samples were taken every 30 min from 0 to 180 min following a 400 kcal test meal. Samples were taken from 12 normal weight subjects with a body mass index (BMI) of 23.2 (2.8) kg/m(2) (median [interquartile range (IQR)]) and seven obese patients with a BMI of 47.2 (7.2) kg/m(2). Fractionated bile acids were measured on these samples using high-performance liquid chromatography tandem mass spectrometry. RESULTS: The obese subjects showed a lower postprandial response in total bile acids compared with the normal weight subjects. An increase of 6.4 (5.0) and 2.6 (3.3) micromol/L (median [IQR]) in normal weight and obese subjects was observed, respectively (P = 0.02). The difference was predominantly due to the glycine-conjugated fraction (P = 0.03). There was no difference in the increase of the unconjugated or taurine-conjugated fractions. CONCLUSIONS: The decreased postprandial bile acid response in obese subjects compared with normal weight subjects may partly explain the suboptimal GLP-1 and PYY responses and could affect appetite, glycaemic control and energy expenditure.

Postoperative esophageal physiology studies may help to predict long-term symptoms following laparoscopic Nissen fundoplication.

BACKGROUND: Laparoscopic Nissen fundoplication is an established treatment for gastroesophageal reflux disease (GERD). Postoperative improvement in esophageal physiology can be indicative of successful surgery, but the degree to which it correlates with symptom control remains questionable. We have performed this study to assess the utility of postoperative esophageal physiology studies in predicting long-term symptomatic outcome. METHODS: Between August 1997 and August 2003, 145 patients with symptomatic GERD underwent laparoscopic Nissen fundoplication as part of a randomized trial. Four months after surgery patients were invited to have postoperative esophageal physiology studies. In November 2005, a postal questionnaire was sent to all patients in order to assess reflux symptomatology (DeMeester symptom score). RESULTS: Completed symptom questionnaires were returned by 108 patients (74%) after a median of 5.7 years postoperatively. Linear regression of manometry data showed a significant correlation between the level of postoperative neosphincter pressure either above or below the median and long-term scores for heartburn (p = 0.03), dysphagia (p = 0.02), regurgitation (p = 0.01), and total symptom score (p = 0.002). In contrast, there was no evidence of a significant correlation between results of postoperative esophageal pH studies and symptom scores. CONCLUSION: Postoperative physiology studies, particularly manometry, may be predictive of long-term symptoms following laparoscopic Nissen fundoplication.

Does open surgery continue to have a role in elective splenectomy?

BACKGROUND: Since it was first reported in 1991, laparoscopic splenectomy has become the procedure of choice for elective splenectomy. However, doubts have been raised regarding the suitability of patients with splenomegaly (>1 kg) for laparoscopic resection because there have been reports of greater morbidity and higher conversion rates in this group of patients. Since 2000, patients referred to the authors' center for splenectomy with an estimated spleen weight exceeding 1 kg have undergone splenectomy by the open approach. METHODS: Between September 1995 and April 2005, 95 elective splenectomies were performed by a single surgeon. Operative data were collected prospectively. RESULTS: A comparison between the operations that took place before 2001 (n = 47) and those performed after 2000 (n = 48) for all sizes of spleen showed significant reductions in conversion rate, operative time, and hospital stay in the later group. As compared with laparoscopic splenectomy (n = 11), open splenectomy (n = 18) for cases of splenomegaly resulted in a significantly shorter operative time, less operative blood loss, and no significant difference in hospital stay. CONCLUSION: Although laparoscopic splenectomy is the treatment of choice for the majority of patients requiring elective splenectomy, the procedure for patients with significant splenomegaly requires caution and common sense. This study shows that an open splenectomy for these patients significantly reduces operative time and blood loss without increasing morbidity or hospital stay.

Randomized clinical trial of laparoscopic Nissen fundoplication compared with proton-pump inhibitors for treatment of chronic gastro-oesophageal reflux.

BACKGROUND: Both laparoscopic Nissen fundoplication (LNF) and proton-pump inhibitor (PPI) therapy are established in the treatment of gastro-oesophageal reflux disease (GORD). The aim of this study was to compare these two treatments in a randomized clinical trial. METHODS: Between July 1997 and August 2001, 340 patients with a history of GORD for at least 6 months were investigated by endoscopy, 24-h pH monitoring and manometry. Of these, 217 were randomized, 109 to LNF and 108 to PPI therapy. The two groups were well matched for age, sex, weight and severity of reflux. Twenty-four-hour pH monitoring and manometry were performed 3 months after treatment, and quality of life was assessed in both groups using the Psychological General Well-being Index and the Gastrointestinal Symptom Rating Scale at 3 and 12 months after treatment. RESULTS: At 3 months there was an improvement in lower oesophageal sphincter pressure from 6.3 to 17.2 mmHg in the LNF group but no change in the PPI group (8.1 and 7.9 mmHg before and after treatment respectively) (P < 0.001). The mean DeMeester acid exposure score improved from 42.7 to 8.6 (P < 0.001) in the LNF group and from 36.9 to 17.7 in the PPI group (P < 0.001). The mean gastrointestinal symptom and general well-being scores improved from 31.7 and 95.4 respectively before treatment to 37.0 and 106.2 at 12 months after LNF, compared with changes from 34.3 and 98.5 to 35.0 and 100.4 respectively in the PPI group. The differences in both of these scores were significant between the two groups at 12 months (P = 0.003). CONCLUSION: LNF leads to significantly less acid exposure of the lower oesophagus at 3 months and significantly greater improvements in both gastrointestinal and general well-being after 12 months compared with PPI treatment.

Short-term cost effectiveness and long-term cost analysis comparing laparoscopic Nissen fundoplication with proton-pump inhibitor maintenance for gastro-oesophageal reflux disease.

BACKGROUND: This study examined the short-term cost-effectiveness and long-term cost of laparoscopic Nissen fundoplication (LNF) versus maintenance proton-pump inhibitor (PPI) medication for severe gastro-oesophageal reflux disease (GORD) based on a randomized clinical trial. METHODS: Costs and outcomes for 12 months were obtained from the first 100 patients in the trial. Detailed costing was performed using resource use data from hospital records and general practitioners' notes. Short-term incremental cost-effectiveness ratios, calculated as the cost difference divided by the effectiveness difference between LNF and PPI therapy, were analysed using net benefit and bootstrap approaches. Long-term cost was examined using sensitivity analyses incorporating published data from other large series. RESULTS: The incremental cost of LNF compared with PPI therapy per additional patient returned to a physiologically normal acid score (less than 13.9) at 3 months was pound5515 (95 per cent confidence interval (c.i.) pound3655 to pound13 400) and the incremental cost per point improvement in combined Gastro-Intestinal and Psychological Well-being score at 12 months was pound293 (90 per cent c.i. pound149 to pound5250). On average, LNF cost pound2247 (95 per cent c.i. pound2020 to pound2473) more than PPI therapy in year 1 and broke even in year 8. Break-even was highly sensitive to hospital unit costs but less sensitive to PPI ingestion rate after LNF, LNF reoperation rate, PPI relapse rate, future PPI price, PPI dose escalation and discount rate. CONCLUSION: From a National Health Service perspective, LNF may be cost-saving after 8 years compared with maintenance PPI therapy for the treatment of GORD.

Prospective randomized trial of laparoscopic (transabdominal preperitoneal) vs open (mesh) repair for bilateral and recurrent inguinal hernia.

BACKGROUND: Laparoscopic hernia repair excites controversy because its benefits are debatable and critics claim it is attended by serious complications. The one group of patients in whom benefits may outweigh the perceived disadvantages are those with bilateral or recurrent inguinal hernias. METHOD: One hundred twenty patients with bilateral or recurrent hernias were randomized to either laparoscopic transabdominal preperitoneal (TAPP) or open mesh repair. Patients completed a well-being questionnaire prior to and following surgery together with a visual analog pain score. Patients were followed up clinically at 1 and 3 months and thereafter by their general practitioner. RESULTS: Age and sex distribution was similar in the two groups. Laparoscopic TAPP hernia was quicker (40 vs 55 min; p < 0.001), less painful (visual analog pain score, 2.8 vs 4.3; p = 0.003) and allowed earlier return to work (11 vs 42 days; p < 0.001) compared to open mesh repair. CONCLUSION: This trial demonstrates that laparoscopic hernia repair via the TAPP route offers significant benefit to patients undergoing bilateral or recurrent inguinal hernia repair.

Laparoscopic distal pancreatectomy. Three cases of insulinoma.

BACKGROUND: Surgery for benign pancreatic disease has traditionally required a major laparotomy however the minimal-access approach is now being applied to a wide variety of procedures, and surgery of the pancreas need not be excluded. METHODS: Laparoscopic distal pancreatectomy was performed on three patients presenting with insulinomas found on preoperative investigation to lie within the tail of the pancreas. RESULTS: All three patients had an excellent clinical outcome and returned to a state of normoglycemia. All of them made a rapid recovery with no major complications. CONCLUSION: Laparoscopic distal pancreatectomy is a viable technique for removing insulinoma of the tail of the pancreas.

Modified Judkins catheters for selective coronary angiography in infants and young children.

The purpose of this study was to assess 4 Fr Judkins catheters with modified shorter tips for performing selective coronary angiography in infants and young children. Twenty patients ranging 6 weeks to 3. 8 years of age were enrolled. Retrograde left heart catheterization and selective coronary angiography were performed. Right (JR) and left (JL) catheters with modified 1.5- and 2.5-cm curves (Cordis) were used. Thirty-six of 37 coronary arteries were successfully cannulated and demonstrated. Median procedure time was 95 sec for the right and 50 sec for the left coronary artery. Median fluoroscopy time was 1.1 min for the right and 0.7 min for the left coronary artery. The JL 1.5 appeared best suited for patients less than 75 cm tall. The JR 1.5 was suitable for patients up to 85 cm tall. Taller patients required the 2.5-cm curves. It is concluded that these modified 4 Fr Judkins catheters were effective.

A multigeneration study to ascertain the toxicological effects of Great Lakes salmon fed to rats: study overview and design.

Fish from the Great Lakes can be contaminated with a plethora of industrial, agricultural, and environmental chemicals. These chemicals have been associated with reproductive and other toxicological effects in fish and fish-eating birds found in the Great Lakes basin. To obtain more insight into this association, several laboratory studies have been undertaken wherein fish have been incorporated into the experimental diets to determine the effect of their ingestion upon the test animals. In addition, several human epidemiological studies have found correlations between Great Lakes fish consumption and effects in neonates which have been attributed to polychlorinated biphenyls without any appreciable consideration as to what synergistic or antagonistic effects other chemicals or heavy metals may or may not have contributed to the observed findings. Herein is presented the design of a two-generation feeding-reproduction study that incorporated lyophilized chinook salmon (Oncorhynchus tsawytscha) fillets into the diets of Sprague-Dawley rats. The findings of this study will be presented in the sections which follow.

Reducing specialty bed use.

Saint Joseph Hospital is a tertiary care teaching facility with 602 licensed beds. In 1992 it was noted that there was a significant rise in the use of specialty beds within the hospital. Guidelines for selection, initiation, and termination were nonexistent. In an effort to reduce high costs associated with specialty bed use a study was conducted to determine appropriate selection criteria and monitor patient outcomes.