Long term efficacy of gastric electrical stimulation in intractable nausea and vomiting

BackgroundAlthough the efficacy of gastric electrical stimulation has been reported in short-term studies, there is a lack of data on the long-term improvement of nausea and vomiting by gastric electrical stimulation in patients with delayed or normal gastric emptying.MethodsThirty-one patients were implanted at our centre for medically refractory severe and chronic nausea and/or vomiting. Patients were evaluated at baseline, 6 months then 5 years after implantation (mean follow-up 80 ± 4 months) using a symptomatic and quality of life scores.Key resultsAmongst the 31 patients, 4 were lost to follow-up, 6 explanted due to lack of improvement, and 1 patient died. Out of the 20 patients evaluated over 5 years, the quality of life score showed 27% improvement (p < 0.01), including nausea (62%; p < 0.01), vomiting (111%; p = 0.03), satiety (158%; p < 0.01), bloating (67%; p < 0.01) and epigastric pain (43%; p = 0.03). Over 5 years, 15/20 patients reported a 50% improvement with a global satisfaction rated at 64 ± 6%. Therefore, 15/27 patients (56%) were improved by gastric electrical stimulation over 5 years in intention to treat. Improvement of nausea 6 months after implantation was predictive of 5-year success of gastric electrical stimulation (p = 0.04). Finally, patients with delayed gastric emptying or with normal gastric emptying rate before surgery were similarly improved over 5 years (60% versus 50% respectively).ConclusionGastric electrical stimulation is safe and effective in the long term in patients with medically refractory nausea and vomiting, with an efficacy over 50% beyond 5 years in intention to treat. Gastric emptying measured before implantation did not influence the response rate over 5 years.     

Too tight to give birth? Assessment of pelvic floor muscle function in 277 nulliparous pregnant women

Introduction and hypothesis

Theoretically, tight or strong pelvic floor muscles may impair the progress of labor and lead to instrumental deliveries. We aimed to investigate whether vaginal resting pressure, pelvic floor muscle strength, or endurance at midpregnancy affect delivery outcome.

Methods

This was a prospective cohort study of women giving birth at a university hospital. Vaginal resting pressure, pelvic floor muscle strength, and endurance in 300 nulliparous pregnant women were assessed at mean gestational week 20.8 (±1.4) using a high precision pressure transducer connected to a vaginal balloon. Delivery outcome measures [acute cesarean section, prolonged second stage of labor (> 2 h), instrumental vaginal delivery (vacuum and forceps), episiotomy, and third- and fourth-degree perineal tear) were retrieved from the hospital’s electronic birth records.

Results

Twenty-three women were lost to follow-up, mostly because they gave birth at another hospital. Women with prolonged second stage had significantly higher resting pressure than women with second stage less than 2 h; the mean difference was 4.4 cmH₂O [95 % confidence interval (CI) 1.2–7.6], p?<?0.01, adjusted odds ratio 1.049 (95 % CI 1.011–1.089, p?=?0.012). Vaginal resting pressure did not affect other delivery outcomes. Pelvic floor muscle strength and endurance similarly were not associated with any delivery outcomes.

Conclusions

While midpregnancy vaginal resting pressure is associated with prolonged second stage of labor, neither vaginal resting pressure nor pelvic floor muscle strength or endurance are associated with operative delivery or perineal tears. Strong pelvic floor muscles are not disadvantageous for vaginal delivery.     

Subjective and objective results of arthroscopic debridement of ulnar-sided TFCC (Palmer type 1B) lesions with stable distal radio-ulnar joint

Purpose

The purpose of this study was to determine functional and subjective results of patients who received arthroscopic debridement for their TFCC Palmer 1B lesions and to compare their results with those of arthroscopic suture repair.

Methods

Between March 2007 and August 2011, 36 patients were diagnosed with Palmer type 1B tears and underwent arthroscopic debridement. 31 patients (15 males and 16 females) were followed up for an average of 26.7 months (±17.4 months) postoperatively. Their average age was 36.7 years (±12.7 years). Follow-up included the determination of range of motion (ROM), grip strength, pain, and wrist scores (modified Mayo wrist score (MMWS), Disabilities of the Arm, Shoulder and Hand questionnaire (DASH score)).

Results

Postoperative ROM averaged 99.2 % for the extension/flexion arc, 95.5 % for the radial/ulnar deviation arc, and 99.4 % for the pronation/supination arc of motion when compared with the contralateral wrist. The MMWS was rated excellent in 48 % of patients, good in 39 %, fair in 13 %, and poor in 0 %. The average DASH score was 17.02 (±14.92). There was a significant reduction in pain. The grip strength was 96.7 % (±15.8), pulp-to-pulp pinch 101.9 % (±17.4), and the ulnar variance ?0.12 ± 1.69 mm.

Conclusions

Arthroscopic debridement of Palmer type 1B lesions in stable DRUJ yields satisfactory to excellent results. Our study showed similar results compared with the studies of arthroscopic suture repair with shorter postoperative care and fewer complications.     

Surgical treatment for nonspecific esophageal motility disorders

Purpose

Nonspecific esophageal motility disorder (NEMD) is a vague category that includes patients with poorly defined contraction abnormalities observed during esophageal manometry. This study investigated the therapeutic effects of the video-assisted thoracoscopic surgery (VATS) approach using long myotomy and fundopexy for NEMD.

Methods

The VATS approach using myotomy and fundopexy was performed for 4 patients of NEMD between 2005 and 2008. A total of 4 patients with NEMD that underwent treatment at our institution were analyzed retrospectively.

Results

The patients included 2 males and 2 females with a median age of 48 years (range 21–74 years). The median duration of NEMD symptoms was 58 months (range 4–108 months). Dysphagia was a primary symptom in all patients. Chest pain was a primary symptom in 3 of 4 patients (75 %). Treatment with medication was attempted before the operation. The median operative time was 344.5 min (range 210–476 min). The median time before starting oral feeding was 2.5 days (range 2–22 days). All patients achieved a significant improvement of their previous condition.

Conclusions

The VATS approach using myotomy and fundopexy for NEMD is a good treatment in cases resistant to medication and balloon dilation.     

Three-dimensional evaluation of volume change in ossification of the posterior longitudinal ligament of the cervical spine using computed tomography

Background

Two-dimensional imaging is not adequate for evaluating ossification of the posterior longitudinal ligament (OPLL). This study was designed to evaluate the accuracy of a novel computed tomography (CT)-based three-dimensional (3D) analysis method that we had devised to measure volume changes in OPLL.

Subjects and methods

Twenty OPLL patients (12 male and 8 female; mean age 63.6 years) who were being followed conservatively were examined twice with an interval of at least 1 year between the two scans. The mean interval was 22 (range 12–45) months. A 3D model was created with DICOM data from CT images, using the MIMICS^® software to calculate the volume. The mean ossification volume was determined from two measurements. Since ossification size varies widely, evaluation of change in volume is generally affected by the original size. Therefore, the change in ossification volume between the first and second CT examinations was calculated as the annual rate of progression.

Results

The type of OPLL was classified as continuous in 3 patients, segmented in 3, and mixed in 14. The mean ossification volume was 1,831.68 mm³ at the first examination and 1,928.31 mm³ at the second, showing a significant mean increase in ossification volume. The mean annual rate of lesion increase was 3.33 % (range 0.08–7.79 %).

Conclusion

The 3D method used allowed detailed OPLL classification and quantification of change in the ossified volume. Thus, this method appears to be very useful for quantitative evaluation of OPLL with only minimal measurement error.     

Serum Vitamin D Increases with Weight Loss in Obese Subjects 6 Months After Roux-en-Y Gastric Bypass

Background

Malabsorptive surgical procedures lead to deficiencies in fat-soluble vitamins. However, results concerning serum vitamin D (25OHD) after gastric bypass (GBP) are controversial. The aim of the study was to assess the influence of GBP on 25OHD and calcium metabolism.

Methods

Parameters of calcium metabolism were evaluated in 202 obese subjects before and 6 months after GBP. Thirty of them were matched for age, gender, weight, skin color, and season with 30 subjects who underwent sleeve gastrectomy (SG). A multivitamin preparation that provides 200 to 500 IU vitamin D3 per day was systematically prescribed after surgery.

Results

In the 202 patients after GBP, serum 25OHD significantly increased from 13.4?±?9.1 to 22.8?±?11.3 ng/ml (p?<?0.0001), whereas parathyroid hormone (PTH) did not change. Despite a decrease in calcium intake (p?<?0.0001) and urinary calcium/creatinine ratio (p?=?0.015), serum calcium increased after GBP (p?<?0.0001). Preoperatively, 91 % of patients had 25OHD insufficiency (<30 ng/ml), 80 % deficiency (<20 ng/ml), and 19 % secondary hyperparathyroidism (>65 pg/ml) vs. 76, 44, and 17 %, respectively, following GBP. Serum 25OHD was negatively correlated with BMI at 6 months after GBP (R?=??0.299, p?<?0.0001). In the two groups of 30 subjects, serum 25OHD and PTH did not differ at 6 months after GBP or SG.

Conclusions

At 6 months after GBP, serum 25OHD significantly increased in subjects supplemented with multivitamins containing low doses of vitamin D. These data suggest that weight loss at 6 months after surgery has a greater influence on vitamin D status than malabsorption induced by GBP.     

Usefulness of perflubutane microbubble-enhanced ultrasound in imaging and detection of prostate cancer: phase II multicenter clinical trial

Purpose

To explore the possibility of targeted biopsy (TBx) using transrectal ultrasound (US) with perflubutane microbubbles, we studied the findings of different cancerous tissue imaging modalities and evaluated needle biopsy in prostate cancer (PCa) using contrast-enhanced US (CEUS) in a multicenter clinical trial.

Methods

Seventy-one patients undergoing prostate biopsy received intravenous injection of perflubutane microbubbles (Sonazoid^®). We evaluated and compared images obtained by CEUS. The safety observation period was 2 days after contrast administration.

Results

Among the 30 patients with cancer, one or more sites with findings suggestive of cancer in CEUS were detected in 23 patients (32.4%) by TBx. Although 22 patients had positive cores of cancer by systematic biopsy (SBx), 8 patients had positive cores of cancer in TBx alone (11.3%). There was a significant difference in cancer detection rate by TBx between two cohorts with PSA < 10 ng/mL (22.9%) and PSA ≥ 10 ng/mL (52.2%) (P < 0.02). Close observation of various CEUS findings with Sonazoid^® enabled targeting of cancerous areas, and consequently, a significant difference (P < 0.05) in the detection rate of cancer was recognized in the transition zone (TZ): SBx; 21/120 (17.5%) and TBx; 17/55 (30.9%). The incidence of adverse events was 6.7% and that of adverse reactions was 4%.

Conclusions

CEUS with Sonazoid^® improved the detection rate of PCa by visualizing cancerous lesions. More detailed examination of CEUS images provided efficient characterization especially in the TZ area. TBx according to this procedure is expected to enable a lower number of biopsies and more accurate diagnosis of PCa.     

The impact of lymph node status and features on oncological outcomes in urothelial carcinoma of the upper urinary tract (UTUC) treated by nephroureterectomy

Purpose

Prognostic impact of lymphadenectomy during radical nephroureterectomy (RNU) for urothelial carcinoma of the upper urinary tract (UTUC) is controversial. Our aim was to assess the impact of lymph node status (LNS) on survival in patients treated by RNU.

Methods

In our multi-institutional, retrospective database, 714 patients with non-metastatic UTUC had undergone RNU between 1995 and 2010. LNS was tested as prognostic factor for survivals through univariate and multivariable Cox regression analysis.

Results

Median age was 70 years [interquartile range (IQR), 60–75] with median follow-up of 27 months (IQR, 10–50). Overall, lymphadenectomy was performed in 254 patients (35.5 %). Among these patients, 204 (80 %) had negative lymph nodes (pN0) and 50 (20 %) had positive lymph nodes (pN1/2). The 5-year cancer-specific survival (CSS) was 81 % [95 % confidence interval (CI), 73–88 %] for pN0 patients, 85 % (95 % CI, 80–90 %) for pNx patients and 47 % (95 % CI, 24–69 %) for pN1/2 patients (p < 0.001). Metastasis-free survival (MFS) and overall survival (OS) rates were significantly lower in pN1/2 patients than in pN0 and pNx patients (p < 0.05). On multivariable analysis, LNS did not appear as an independent prognostic factor for CSS, OS or MFS (p > 0.05). In case of lymph node involvement, extra-nodal extension was marginally associated with worse CSS (log rank p = 0.07). The retrospective design was the main limitation.

Conclusion

LNS is helpful for survival stratification in patients treated with RNU for UTUC. However, LNS did not appear as an independent predictor of survival in this retrospective series and needs to be investigated in a large multicentre, prospective evaluation.     

18F‐fluoride PET as a noninvasive imaging biomarker for determining treatment efficacy of bone active agents at the hip: A prospective,randomized, controlled clinical study

The functional imaging technique of ¹⁸F‐fluoride positron emission tomography (¹⁸F‐PET) allows the noninvasive quantitative assessment of regional bone formation at any skeletal site, including the spine and hip. The aim of this study was to determine if ¹⁸F‐PET can be used as an early biomarker of treatment efficacy at the hip. Twenty‐seven treatment‐naive postmenopausal women with osteopenia were randomized to receive teriparatide and calcium and vitamin D (TPT group, n = 13) or calcium and vitamin D only (control group, n = 14). Subjects in the TPT group were treated with 20 µg/day teriparatide for 12 weeks. ¹⁸F‐PET scans of the proximal femur, pelvis, and lumbar spine were performed at baseline and 12 weeks. The plasma clearance of ¹⁸F‐fluoride to bone, K_i, a validated measurement of bone formation, was measured at four regions of the hip, lumbar spine, and pelvis. A significant increase in K_i was observed at all regions of interest (ROIs), including the total hip (+27%, p = 0.002), femoral neck (+25%, p = 0.040), hip trabecular ROI (+21%, p = 0.017), and hip cortical ROI (+51%, p = 0.001) in the TPT group. Significant increases in K_i in response to TPT were also observed at the lumbar spine (+18%, p = 0.001) and pelvis (+42%, p = 0.001). No significant changes in K_i were observed for the control group. Changes in BMD and bone turnover markers were consistent with previous trials of teriparatide. In conclusion, this is the first study to our knowledge to demonstrate that ¹⁸F‐PET can be used as an imaging biomarker for determining treatment efficacy at the hip as early as 12 weeks after initiation of therapy.