Gregory E. Wilding

Comparison of gastric emptying of a nondigestible capsule to a radio-labelled meal in healthy and gastroparetic subjects

Background  Gastric emptying scintigraphy (GES) using a radio‐labelled meal is used to measure gastric emptying. A nondigestible capsule, SmartPill, records luminal pH, temperature, and pressure during gastrointestinal transit providing a measure of gastric emptying time (GET).

Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study.

Background: Approximately 10% of patients with plantar fasciitis have development of persistent and often disabling symptoms. A poor response to treatment may be due, in part, to inappropriate and nonspecific stretching techniques. We hypothesized that patients with chronic plantar fasciitis who are managed with the structure-specific plantar fascia-stretching program for eight weeks have a better functional outcome than do patients managed with a standard Achilles tendon-stretching protocol. Methods: One hundred and one patients who had chronic proximal plantar fasciitis for a duration of at least ten months were randomized into one of two treatment groups. The mean age was forty-six years. All patients received prefabricated soft insoles and a three-week course of celecoxib, and they also viewed an educational video on plantar fasciitis. The patients received instructions for either a plantar fascia tissue-stretching program (Group A) or an Achilles tendon-stretching program (Group B). All patients completed the pain subscale of the Foot Function Index and a subject-relevant outcome survey that incorporated generic and condition-specific outcome measures related to pain, function, and satisfaction with treatment outcome. The patients were reevaluated after eight weeks. Results: Eighty-two patients returned for follow-up evaluation. With the exception of the duration of symptoms (p < 0.01), covariates for baseline measures revealed no significant differences between the groups. The pain subscale scores of the Foot Function Index showed significantly better results for the patients managed with the plantar fascia-stretching program with respect to item 1 (worst pain; p = 0.02) and item 2 (first steps in the morning; p = 0.006). Analysis of the response rates to the outcome measures also revealed significant differences with respect to pain, activity limitations, and patient satisfaction, with greater improvement seen in the group managed with the plantar fascia-stretching program. Conclusions: A program of non-weight-bearing stretching exercises specific to the plantar fascia is superior to the standard program of weight-bearing Achilles tendon-stretching exercises for the treatment of symptoms of proximal plantar fasciitis. These findings provide an alternative option to the present standard of care in the nonoperative treatment of patients with chronic, disabling plantar heel pain. Level of Evidence: Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). See Instructions to Authors for a complete description of levels of evidence.

Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up

BACKGROUND In a previous investigation, eighty-two patients with chronic proximal plantar fasciitis for a duration of more than ten months completed a randomized, prospective clinical trial. The patients received instructions for either a plantar fascia-stretching protocol or an Achilles tendon-stretching protocol and were evaluated after eight weeks. Substantial differences were noted in favor of the group managed with the plantar fascia-stretching program. The goal of this two-year follow-up study was to evaluate the long-term outcomes of the plantar fascia-stretching protocol in patients with chronic plantar fasciitis. METHODS Phase one of the clinical trial concluded at eight weeks. At the eight-week follow-up evaluation, all patients were instructed in the plantar fascia-stretching protocol. At the two-year follow-up evaluation, a questionnaire consisting of the pain subscale of the Foot Function Index and an outcome survey related to pain, function, and satisfaction with treatment was mailed to the eighty-two subjects who had completed the initial clinical trial. Data were analyzed with use of a mixed-model analysis of covariance for each outcome of interest. RESULTS Complete data sets were obtained from sixty-six patients. The two-year follow-up results showed marked improvement for all patients after implementation of the plantar fascia-stretching exercises, with an especially high rate of improvement for those in the original group treated with the Achilles tendon-stretching program. In contrast to the eight-week results, the two-year results showed no significant differences between the groups with regard to the worst pain or pain with first steps in the morning. Descriptive analysis of the data showed that 92% (sixty-one) of the sixty-six patients reported total satisfaction or satisfaction with minor reservations. Fifty-one patients (77%) reported no limitation in recreational activities, and sixty-two (94%) reported a decrease in pain. Only sixteen of the sixty-six patients reported the need to seek treatment by a clinician. CONCLUSIONS This study supports the use of the tissue-specific plantar fascia-stretching protocol as the key component of treatment for chronic plantar fasciitis. Long-term benefits of the stretch include a marked decrease in pain and functional limitations and a high rate of satisfaction. This approach can provide the health-care practitioner with an effective, inexpensive, and straightforward treatment protocol.

Delay to formalin fixation effect on breast biomarkers.

Delay to formalin fixation may invalidate hormone receptors and HER2 analyses. Invalid results of tumor markers could significantly alter the type of adjuvant therapy a patient receives and potentially impact outcome. The purpose of this study was to determine the effects of progressive delay to formalin fixation on breast cancer biomarkers. Ten palpable invasive breast cancers were resected and underwent immediate gross evaluation. For each case, the procured tumor was divided into eight parts and consecutively fixed after 0, 10, 30 min, 1, 2, 4, and 8 h; one section was kept in saline and stored overnight at 4°C. Two tissue microarray blocks were constructed. Estrogen and progesterone receptors and HER2 immunohistochemistry and fluorescence in situ hybridization were carried out. Statistical analyses including non-parametric sign test, exact McNemars test and Pages L test were used. All 10 cases were invasive ductal carcinomas. Q score ⩾6 was identified in five cases for estrogen receptor and four for progesterone receptor. Mean Q score started to decline at the 2 h mark for estrogen receptor and 1 h mark for progesterone receptor. Lowest score was at 8 h mark for estrogen receptor and overnight for progesterone receptor. HER2 fluorescence in situ hybridization started to be compromised for interpretation at the 1 h mark and became statistically significant at the 2 h mark (P<0.03). To avoid delay to formalin fixation as a factor negatively affecting on breast biomarkers, we recommend not to delay formalin fixation for more than 1 h and not to store specimens overnight.

Do Stool Form and Frequency Correlate With Whole-Gut and Colonic Transit? Results From a Multicenter Study in Constipated Individuals and Healthy Controls

OBJECTIVES:Despite a lack of supportive data, stool form and stool frequency are often used as clinical surrogates for gut transit in constipated patients. The aim of this study was to assess the correlation between stool characteristics (form and frequency) and gut transit in constipated and healthy adults.METHODS:A post hoc analysis was performed on 110 subjects (46 chronic constipation) from nine US sites recording stool form (Bristol Stool Scale) and frequency during simultaneous assessment of whole-gut and colonic transit by wireless motility capsule (WMC) and radio-opaque marker (ROM) tests. Stool form and frequency were correlated with transit times using Spearmans rank correlation. Accuracy of stool form in predicting delayed transit was assessed by receiver operating characteristic analysis.RESULTS:In the constipated adults (42 females, 4 males), moderate correlations were found between stool form and whole-gut transit measured by WMC (r=−0.61, P<0.0001) or ROM (−0.45, P=0.0016), as well as colonic transit measured by WMC (−0.62, P<0.0001). A Bristol stool form value <3 predicted delayed whole-gut transit with a sensitivity of 85% and specificity of 82% and delayed colonic transit with a sensitivity of 82% and specificity of 83%. No correlation between stool form and measured transit was found in healthy adults, regardless of gender. No correlation was found between stool frequency and measured transit in constipated or healthy adults. The correlation between stool frequency and measured transit remained poor in constipated adults with <3 bowel movements per week.CONCLUSIONS:Stool form predicts delayed vs. normal transit in adults. However, only a moderate correlation exists between stool form and measured whole-gut or colonic transit time in constipated adults. In contrast, stool frequency is a poor surrogate for transit, even in those with reduced stool frequency.

Wireless pH‐motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation

Background  Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information.

The assessment of regional gut transit times in healthy controls and patients with gastroparesis using wireless motility technology

Background  Wireless pH and pressure motility capsule (wireless motility capsule) technology provides a method to assess regional gastrointestinal transit times.

Prospective Clinical Trial of Preoperative Sunitinib in Patients With Renal Cell Carcinoma

PURPOSE Sunitinib is an approved treatment for metastatic renal cell carcinoma. We performed a prospective clinical trial to evaluate the safety and clinical response to sunitinib administered before nephrectomy in patients with localized or metastatic clear cell renal cell carcinoma. MATERIALS AND METHODS Patients with biopsy proven clear cell renal cell carcinoma were enrolled in the study and treated with 37.5 mg sunitinib malate daily for 3 months before nephrectomy. The primary end point was safety. RESULTS In an 18-month period 20 patients were enrolled. The most common toxicities were gastrointestinal symptoms and hematological effects. Grade 3 toxicity developed in 6 patients (30%). No surgical complications were attributable to sunitinib treatment. Of the 20 patients 17 (85%) experienced reduced tumor diameter (mean change -11.8%, range -27% to 11%) and cross-sectional area (mean change -27.9%, range -43% to 23%). Enhancement on contrast enhanced computerized tomography decreased in 15 patients (mean HU change -22%, range -74% to 29%). After tumor reduction 8 patients with cT1b disease underwent laparoscopic partial nephrectomy. Surgical parameters, such as blood loss, transfusion rate, operative time and complications, were similar to those in patients who underwent surgery during the study period and were not enrolled in the trial. CONCLUSIONS Preoperative treatment with sunitinib is safe. Sunitinib decreased the size of primary renal cell carcinoma in 17 of 20 patients. Future trials can be considered to evaluate neoadjuvant sunitinib to maximize nephron sparing and decrease the recurrence of high risk, localized renal cell carcinoma.

Fundamental Skills of Robotic Surgery: A Multi-institutional Randomized Controlled Trial for Validation of a Simulation-based Curriculum

OBJECTIVE To develop and establish effectiveness of simulation-based robotic curriculum--fundamental skills of robotic surgery (FSRS). METHODS FSRS curriculum was developed and incorporated into a virtual reality simulator, Robotic Surgical Simulator (RoSS). Fifty-three participants were randomized into an experimental group (EG) or control group (CG). The EG was asked to complete the FSRS and 1 final test on the da Vinci Surgical System (dVSS). The dVSS test consisted of 3 tasks: ball placement, suture pass, and fourth arm manipulation. The CG was directly tested on the dVSS then offered the chance to complete the FSRS and re-tested on the dVSS as a crossover (CO) group. RESULTS Sixty-five percent of participants had never formally trained using laparoscopic surgery. Ball placement: the EG demonstrated shorter time (142 vs 164 seconds, P = .134) and more precise (1.5 vs 2.5 drops, P = .014). The CO took less time (P <.001) with greater precision (P <.001). Instruments were rarely lost from the field. Suture pass: the EG demonstrated better camera utilization (4.3 vs 3.0, P = .078). Less instrument loss occurred (0.5 vs 1.1, P = .026). Proper camera usage significantly improved (P = .009). Fourth arm manipulation: the EG took less time (132 vs 157 seconds, P = .302). Meanwhile, loss of instruments was less frequent (0.2 vs 0.8, P = .076). Precision in the CO improved significantly (P = .042) and camera control and safe instrument manipulation showed improvement (1.5 vs 3.5, 0.2 vs 0.9, respectively). CONCLUSION FSRS curriculum is a valid, feasible, and structured curriculum that demonstrates its effectiveness by significant improvements in basic robotic surgery skills.

Face Validation of a Novel Robotic Surgical Simulator

OBJECTIVES To assess the face validity of Robotic Surgery Simulator (RoSS), a novel virtual reality training platform for the da Vinci Surgical System (DVSS). METHODS Urologic surgeons, fellows, and residents attending the 2009 American Urologic Association Annual Meeting in April 2009 were invited to an orientation session with RoSS. Participants completed a questionnaire after orientation and two modules. RESULTS Thirty participants including 24 surgeons and fellows experienced with robotic surgery and 6 robotic surgery novices participated in the study. Eighty percent participants had at least 4 years of experience with robotic surgery and 77% had performed an average of 340 cases on the DVSS as primary console surgeons. Subjects indicated that RoSS was realistically close to the DVSS console in terms of virtual simulation and instrumentation. Fifty-two percent of subjects rated RoSS somewhat close and 45% rated RoSS very close to the DVSS console. Thirty-seven percent rated RoSS pinch device somewhat close, and 47% very close to the DVSS. With regard to movement of the arms, 43% rated it somewhat close, 40% rated it very close, and 7% felt that it was just like the DVSS. Camera movement and clutch functions were rated not close (11%), somewhat close (57%), and very close (32%) to the DVSS. Data were further analyzed in terms of surgical volume. Thirty-eight percent of subjects had also tried the Mimic dV-Trainer robotic surgery simulator. CONCLUSIONS RoSS provides opportunity for robot-assisted surgical training for future error-free surgery. Further validation will be necessary to assess RoSS and the application of specific modules for robot-assisted surgical training.