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.

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.

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.

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.

An explanation for discrepancy between angiographic and intravascular ultrasound measurements after percutaneous transluminal coronary angioplasty.

OBJECTIVES: This study attempted to determine why there is a discrepancy between angiographic and intravascular ultrasound measurements after coronary balloon angioplasty. BACKGROUND: Previous studies have shown a poor correlation between angiographic and intravascular ultrasound measurements after percutaneous coronary balloon angioplasty. METHODS: After successful balloon angioplasty, 91 lesions in 84 patients were studied by intravascular ultrasound. Plaque morphology on intravascular ultrasound was classified as demonstrating a superficial injury if there was either no fracture or only a small tear that did not extend to the media versus a deep injury defined as the presence of a plaque fracture that reached the media. Measurements of minimal lumen diameter were compared between angiography and intravascular ultrasound. RESULTS: On ultrasound imaging, a superficial injury pattern was observed in 44 lesions, whereas a deep injury was seen in 47 lesions. There were no statistical differences at baseline in patient or lesion characteristics. In the superficial injury group there was a significant correlation between angiography and intravascular ultrasound for minimal lumen diameter (r = 0.67) and lumen cross-sectional area (r = 0.69). In the deep injury group there was a poor correlation for minimal lumen diameter (r = 0.05) and lumen cross-sectional area (r = 0.28). After balloon angioplasty, the angiographic appearance showed a normal contour in 34%, the presence of dissection in 38% or a hazy appearance in 23%. On ultrasound imaging after angioplasty, the superficial injury group comprised 65% of lesions with a normal angiographic appearance and 67% of lesions with a hazy appearance, whereas 77% of lesions with an angiographic diagnosis of dissection were in the deep injury group by ultrasound (p = 0.0005). CONCLUSIONS: These observations suggest that the discrepancies between angiographic and ultrasound measurements are due to differences in plaque morphology created by balloon dilation. Superficial injuries demonstrate similar results by angiography or ultrasound, whereas a deep injury to the plaque produces a difference in measurements between angiography and ultrasound. When angiography reveals a dissection, there is a high probability that intravascular ultrasound will demonstrate a plaque fracture extending to the media.

Intravascular ultrasound imaging.

Intravascular ultrasound imaging is a useful and promising modality that is capable of demonstrating the structure of blood vessel walls. It also provides a quantitative assessment of the amount of atheroma present that cannot be visualized by angiography. This article reviews the basic principles of intravascular ultrasound imaging and describes the clinical studies after balloon angioplasty evaluated by intravascular ultrasound imaging.

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.

Stoichiometry of the aldehyde fuchsin staining reaction for proteins.

Model systems of agar films containing known concentrations of bovine serum albumin and alpha-chymotrypsinogen were stained with aldehyde fuchsin after oxidation with acidified permanganate solution. These films were scanned in a scanning microphotometer to determine the mean extinction and the total extinction of predetermined areas. Results indicate that the dye binds quantitatively to the proteins. Blocking the acidic side groups of the proteins inhibited the binding of the dye. The degree of inhibition was directly related to the number of sulfhydryl or carboxyl groups that were blocked. Similar blocking reactions performed on the type "A" neurosecretory cells of the pars intercerebralis of the insect Oncopeltus fasciatus gave similar results. Analysis of the dye protein complexes gave a dye to acidic group ratio of 1:1.

Measurement of cardiac output by automated single-breath technique, and comparison with thermodilution and Fick methods in patients with cardiac disease.

Accurate noninvasive methods are needed for determination of cardiac output. Current methods are generally complex or may be unreliable. A previously described method, based on absorption of acetylene gas during a constant exhalation that enables calculation of cardiac output by estimating pulmonary capillary circulation, is incorporated in a new, automated commercial product (SensorMedics 2200). In this study, cardiac output by single-breath acetylene blood flow measured with this device was compared with the standard thermodilution and direct Fick methods in 20 patients undergoing cardiac or pulmonary artery catheterization. Patients inhaled test gas mixture to total lung capacity and exhaled at a constant rate through an adjustable resistor. Lung volumes and noninvasive acetylene blood flow value were calculated automatically. Correlation between the automated single-breath technique and both thermodilution and Fick cardiac output determinations was very high (correlation coefficients were 0.90 and 0.92, respectively), regression slopes were close to identity (0.98 and 0.90), and bias (-0.39 and -0.79 liter/min) and precision (0.94 and 1.02) were good; when shunt correction was applied, bias was reduced to 0.06 and 0.35 liter/min, respectively. Rapid, accurate, noninvasive measurement of cardiac output was easily obtained using the automated device. This technique may have a wide applicability for noninvasive evaluation of patients with cardiac disease and for monitoring effects of therapeutic interventions.

The reproducibility of intravascular ultrasound imaging in vitro.

To determine which factors may affect the image quality when an intravascular ultrasound catheter is used in vivo, the influence of blood, temperature change, and contrast media were evaluated. In addition, to confirm the reproducibility of intravascular ultrasound imaging to measure cross-sectional lumen area, intraobserver and interobserver variability were determined. The findings indicated that ultrasound images in blood are mildly attenuated, that changes from room temperature to body temperature do not have a significant impact on the image quality, that contrast media attenuates the image intensity in a dose-dependent manner, and that the intravascular ultrasound imaging catheter provides a reproducible method for measuring arterial lumen area with excellent intraobserver and interobserver correlation.

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.

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.

Primary leiomyosarcoma of the greater omentum: case report and review of the literature.

Omental leiomyosarcomas are rare intra-abdominal tumors. This report describes a case of primary leiomyosarcoma of the greater omentum discovered on abdominal CT scan. The mass was removed via laparotomy and an omentectomy performed. At 2 years postoperatively there is no sign of tumor recurrence or metastasis.

Intravascular ultrasonic imaging.

Because conventional imaging methods are inadequate for evaluating human coronary arteries in vivo, an intravascular ultrasonic imaging catheter was developed that allows the arterial wall to be studied in cross-section from within the artery. The catheter incorporates a mechanically rotating 20-MHz transducer, which is designed so that the ringdown occurs within the catheter and imaging is permitted up to the catheter's surface. The device rotates at 1800-rpm within a plastic sleeve and provides real-time cross-sectional images at 30 frames/sec. Preliminary experimental and clinical studies indicate that the intravascular ultrasonic imaging catheter could play a valuable role in providing preoperative information concerning arterial wall thickness and tissue characteristics, in distinguishing normal from diseased arterial wall structures during therapeutic intervention, and in assessing the results of intervention.

Analysis of posttraumatic syndrome following a mild head injury.

Medical, financial and legal implications of prolonged disability after mild head injury are significant. In this study, researchers examined symptoms and psychosocial sequelae of head trauma three and six months after mild head injury in a group of 75 adult patients admitted to the trauma service of St. Anthony Hospital, Denver, Colorado. Results support the following conclusions: (1) nursing observation plays a key role in identification of patients at risk for posttraumatic syndrome; (2) early intervention may facilitate the recovery process; (3) support from family and significant others is an important aspect of recovery; and (4) as expressed by patients and family during follow-up interviews, education by nurses is an important factor in lowering anxiety and frustration during recovery. Data collected identify patients at risk for difficulties in recovery. Symptoms most frequently seen and average length of recovery were also addressed in the study.

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.