Prospective, Randomized Trial Comparing General with Spinal Anesthesia for Cesarean Delivery in Preeclamptic Patients with a Nonreassuring Fetal Heart Trace

Background: There are no randomized studies on neonatal outcome after spinal versus general anesthesia for cesarean delivery in preeclamptic patients with a nonreassuring fetal heart trace. This study examined both markers of neonatal hypoxia and maternal hemodynamics.

Methods: Seventy patients were randomized to general (n = 35) or spinal anesthesia (n = 35). The general anesthesia group received thiopentone, magnesium sulfate, and suxamethonium intravenously before intubation, followed by 50% nitrous oxide in oxygen, 0.75-1.5% isoflurane, and morphine after delivery. The target end-tidal partial pressure of carbon dioxide (Pco2) was 30-34 mmHg. The spinal anesthesia group received 1.8 ml hyperbaric bupivacaine plus 10 [mu]g fentanyl at the L3-L4 interspace. Heart rate and blood pressure were measured at specific time points. Hypotension was treated with ephedrine. Maternal arterial and neonatal umbilical arterial blood gas samples were taken at delivery. Resuscitation requirements were recorded.

Results: In both groups, hemodynamic measures remained within acceptable limits. Spinal anesthesia patients required more ephedrine (13.7 vs. 2.7 mg). Maternal Paco2 was lower in the spinal group (28.9 vs. 32.4 mmHg). One-minute Apgar scores were lower after general anesthesia. Base deficit was greater (7.13 vs. 4.68 mEq/l) and neonatal umbilical arterial pH was lower (7.20 vs. 7.23) after spinal anesthesia. Post hoc analysis showed that if maternal diastolic blood pressure on admission was greater than 110 mmHg, neonatal umbilical arterial base deficit was greater after spinal anesthesia. There was no difference in the number of patients with Apgar scores less than 7 at 1 or 5 min or umbilical arterial pH less than 7.2 or in the requirements for resuscitation.     

Extracorporeal Shock Wave Therapy for Chronic Painful Heel Syndrome: A Prospective, Double Blind, Randomized Trial Assessing the Efficacy of a New Electromagnetic Shock Wave Device

Published data describing the efficacy of extracorporeal shock wave therapy for the treatment of plantar heel pain provide conflicting results, and optimal treatment guidelines are yet to be determined. To assess the efficacy and safety of extracorporeal shockwave therapy compared with placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device, we undertook a prospective, double-blind, randomized, placebo-controlled trial conducted among 40 participants who were randomly allocated to either active, focused extracorporeal shockwave therapy (0.25 mJ/mm(2)) or sham shockwave therapy. Both groups received 3 applications of 2000 shockwave impulses, each session 1 week apart. The primary outcome was the change in composite heel pain (morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter) as quantified using a visual analog pain scale at 12 weeks after completion of the interventions compared with baseline. Secondary endpoints included changes in morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter, as measured on a visual analog pain scale, as well as the change in the Roles and Maudsley score, at 12 weeks after the baseline measurement. Active extracorporeal shockwave therapy resulted in a 73.2% reduction in composite heel pain, and this was a 32.7% greater reduction than that achieved with placebo. The difference was not statistically significant (1-tailed Wilcoxon Mann-Whitney U test, P =.0302), but reached clinical relevance (Mann-Whitney effect size = 0.6737). In regard to the secondary outcomes, active extracorporeal shockwave therapy displayed relative superiority in comparison with the sham intervention. No relevant adverse events occurred in either intervention group. The results of the present study support the use of electromagnetically generated extracorporeal shockwave therapy for the treatment of refractory plantar heel pain.     

Cost-Benefit and Efficacy of Aprotinin Compared with epsilon-Aminocaproic Acid in Patients Having Repeated Cardiac Operations: A Randomized, Blinded Clinical Trial

Background: Aprotinin and epsilon-aminocaproic acid are routinely used to reduce bleeding during cardiac surgery. The marked difference in average wholesale cost between these two drug therapies (aprotinin, $1,080 vs. epsilon-aminocaproic acid, $11) has generated significant controversy regarding their relative efficacies and costs.

Methods: In a multicenter, randomized, prospective, blinded trial, patients having repeated cardiac surgery received either a high-dose regimen of aprotinin (total dose, 6 x 106 kallikrein inactivator units) or epsilon-aminocaproic acid (total dose, 270 mg/kg).

Results: Two hundred four patients were studied. Overall (data are median [25th-75th percentiles]), aprotinin-treated patients had less postoperative thoracic drainage (511 ml [383-805 ml] vs. 655 ml [464-1,045 ml]; P = 0.016) and received fewer platelet transfusions (0 [range, 0-1] vs. 1 [range, 0-2]; P = 0.036). The surgical field was more likely to be considered free of bleeding in aprotinin-treated patients (44% vs. 26%; P = 0.012). No differences, however, were seen in allogeneic erythrocyte transfusions or in the time required for chest closure. Overall, direct and indirect bleeding-related costs were greater in aprotinin- than in epsilon-aminocaproic acid-treated patients ($1,813 [$1,476-2,605] vs. $1,088 [range, $511-2,057]; P = 0.0001). This difference in cost per case varied in magnitude among sites but not in direction.     

Efficacy of GM-CSF as an Adjuvant to Hepatitis B Vaccination in Patients with Chronic Renal Failure—Results of a Prospective,Randomized Trial

Background.?Chronic renal failure patients on hemodialysis are at an increased risk of acquiring hepatitis B infection. Hence vaccination against hepatitis B assumes great importance in these patients. However, the response to hepatitis B vaccination is poor, even when 4 double doses (40 µg) of the vaccine are given. This study was conducted to determine the efficacy of GM-CSF as an adjuvant to hepatitis B vaccine in CRF patients. Methods.?CRF patients including both hemodialysis (HD) and non-dialysis (ND) patients were randomized to receive either placebo or a single injection of GM-CSF (in varying doses of 50 µg, 100 µg, 150 µg) a day prior to the 1st dose of recombinant hepatitis B vaccine (40 µg). Three more doses of the vaccine were given at 1, 2, and 6 months. The anti-HBs antibody titres were measured by ELISA at 3 and 7 months. Patients having antibody titres less than 10 IU/L were considered non-responders. The response rate and mean antibody titers were compared between the control (I) and GM-CSF (II) groups. Results.?In group I, 31 and 27 patients were available for evaluation at 3 and 7 months respectively. In group II, 33 and 28 patients could be evaluated at the same time points. Within the control group (group I), the response rate in hemodialysis patients (63.6%) was lower as compared to non-dialysis patients (81.2%). The response rate in group II was higher than that in group I at both 3 months as well as 7 months (78.1% vs. 62.3% and 89.3% vs. 74.1%, p = ns). The best response rates in group II were observed when GM-CSF was used in a dose of 150 µg (90.9% at 3 months and 100% at 7 months). The mean antibody titers were also found to be higher in the group II as compared to group I (409.6 vs. 243.9 IU/L, p = 0.01). Conclusion.?The results of this randomized, prospective study suggest that: 1. Patients with chronic renal failure should be vaccinated for hepatitis B as chronic renal insufficiency is established. 2. GM-CSF is an effective adjuvant to hepatitis B vaccine in these patients especially when a priming dose of 150 µg is used prior to 1st dose of hepatitis B vaccination.     

Intracranial Pressure and Cerebral Hemodynamic in Patients with Cerebral Tumors: A Randomized Prospective Study of Patients Subjected to Craniotomy in Propofol-Fentanyl, Isoflurane-Fentanyl, or Sevoflurane-Fentanyl Anesthesia

Background: A critical point during craniotomy is opening of dura, where a high intracranial pressure (ICP) results in swelling of cerebral tissue. Controlled studies concerning ICP, degree of dural tension, and degree of cerebral swelling are therefore warranted.

Methods: In an open-label study, 117 patients with supratentorial cerebral tumors were randomized to propofol-fentanyl (group 1), isoflurane-fentanyl (group 2), or sevoflurane-fentanyl anesthesia (group 3). Normo- to moderate hypocapnia was applied, with a target level of arterial carbon dioxid tension of 30-40 mmHg. Mean arterial blood pressure was stabilized with intravenous ephedrine (2.5-5 mg) if necessary. Subdural ICP, mean arterial blood pressure, cerebral perfusion pressure (CPP), arteriovenous oxygen difference (AVDo2), internal jugular vein oxygen saturation were monitored before and after a 10-min period of hyperventilation, and the carbon dioxide reactivity was calculated. Furthermore, the tension of dura before and during hyperventilation and the degree of cerebral swelling during hyperventilation and after opening of the dura were estimated by the neurosurgeon.

Results: No differences were found between groups with regard to demographics, neuroradiologic examination, positioning of the head, and time to ICP measurement. Before and during hyperventilation, ICP was significantly lower and mean arterial blood pressure and CPP significantly higher in group 1 compared with groups 2 and 3 (P < 0.05). The tension of dura before and during hyperventilation was significantly lower in group 1 compared with group2 (P < 0.05), but not significantly different from group 3. In group 1, cerebral swelling after opening of dura was significantly lower compared with groups 2 and 3 (P < 0.05). Furthermore, AVDo2 was significantly higher and jugular vein oxygen saturation and carbon dioxide reactivity were significantly lower in group 1 compared with groups 2 and 3 (P < 0.05). No significant differences with regard to ICP, CPP, AVDo2, carbon dioxide reactivity, and jugular vein oxygen saturation were found between patients anesthetized with isoflurane and sevoflurane.     

Optimal Delivery of Perioperative Chemotherapy: Preliminary Results of a Randomized, Prospective, Comparative Trial of Preoperative and Postoperative Chemotherapy for Invasive Bladder Carcinoma

Purpose

We performed a planned interim analysis of a randomized trial comparing initial to postoperative chemotherapy for bladder cancer. The purpose of our analysis was to detect early evidence of survival differences, tolerance to therapy influenced by the sequence of treatment, predictive value of clinical stage and influence of methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) on bladder resectability.

Materials and Methods

A total of 100 consecutive patients was randomized to receive 2 M-VAC courses before and 3 courses after surgery (group 1) or 5 adjuvant M-VAC courses following cystectomy (group 2). Survival, clinical response, clinical and pathological stage, and toxicity were evaluated in this second timed interim analysis.

Results

Of all patients 70 percent received at least 4 M-VAC courses. Overall survival at 31.7 months (range 1.8 to 87.7) was similar in groups 1 (60 percent) and 2 (63 percent), and independent of clinical stage. Preoperative clinical staging accurately identified patients at high risk for recurrence, while 37 of the 48 group 2 patients (77 percent) were considered at high risk by pathological staging (P3b, P4a, node-positive and unresectable disease). Comparison of pathological stage revealed that 14 of the 51 group 1 patients (28 percent) achieved stage P0 while only 1 of the 48 group 2 patients (2 percent) had P0 disease at surgery (p = 0.00043). Disease was unresectable in 3 group 1 (6 percent) and 8 group 2 patients (17 percent, p = 0.09). Tolerance to treatment was not significantly different in the 2 study arms.

Conclusions

No survival advantage was noted between neoadjuvant and adjuvant M-VAC in our interim analysis. However, results suggest that M-VAC chemotherapy may be effective in increasing the resectability of localized bladder cancer and may contribute to organ preservation. Clinical stage was a reliable predictor of pathological findings at surgery. Future studies can use clinical staging to determine therapy before surgery for the select stages that we treated. Identification of the subset likely to achieve complete pathological remission will permit the selection of patients for organ preservation strategies.     

Antireflux Nipples or Afferent Tubular Segments in 70 Patients with Ileal Low Pressure Bladder Substitutes: Long-term Results of a Prospective Randomized Trial

Purpose

Intestinal low pressure orthotopic bladder substitutes have no major coordinated contractions during micturition. Therefore, the importance and type of reflux prevention were assessed in a prospective randomized study.

Materials and Methods

A total of 70 patients with an ileal low pressure bladder substitute was randomized to receive a nipple valve or an isoperistaltic afferent ileal tubular segment for reflux prevention.

Results

After median observation times of 57 and 45 months, respectively, the results regarding functional reservoir capacity, incidence of infected urine, urinary continence, voiding habits and serum electrolytes, urea and creatinine were similar in both groups. Severe upper tract dilatation due to ureteroileal or nipple stenosis occurred in 9 of 67 evaluable reno-ureteral units (13.5 percent) in patients with antireflux nipples and in 2 of 69 (3 percent) in patients with an afferent tubular segment. This difference in favor of the latter cases in significant (Fisher's exact test p less than 0.03). Video urodynamics did not show reflux of contrast medium during voiding in either group. A simultaneous intravesical, intra-abdominal and intrapelvic pressure increase was noted during the Valsalva maneuver.

Conclusions

While long-term upper tract preservation by an afferent tubular ileal segment must be confirmed in larger patient series with longer followup, our results indicate that reflux prevention in patients with orthotopic low pressure bladder substitutes is not a major concern and does not justify the use of antireflux mechanisms with a high complication rate.     

Improving Stone Clearance After Extracorporeal Shock Wave Lithotripsy in Urolithiasis Patients by a Special Terpene Combination (Rowatinex): Results of a Placebo-Controlled, Randomized Trial

BackgroundExtracorporeal shockwave lithotripsy (ESWL) is the first-choice treatment for most renal stones. Rowatinex^®, a special terpene combination, has been used therapeutically in the supportive treatment of urolithiasis and for assistance in the expulsion of stones of the renal system for many years.ObjectiveThe aim of the study was to investigate the safety and efficacy of Rowatinex^® in the treatment of patients with urolithiasis after ESWL.Design, setting, and participantsIn a randomized, double-blinded, placebo-controlled, multicenter trial, 222 patients with clinically unapparent kidney or ureter stones who had undergone complication-free ESWL were included between June 2003 and December 2006. The study consisted of a 12-wk active treatment phase and a 2-wk follow-up phase. All patients underwent physical examination, and diagnosis of kidney stones was made by x-ray, intravenous pyelogram (IVP), or ultrasound at weeks 1, 4, 8, and 12 as well as after 2 wk of follow-up.InterventionPatients were randomized to receive either 3 × 2 Rowatinex^® capsules per day or placebo.MeasurementsThe primary end point was the rate of stone-free patients (without any fragments) after 12 wk of treatment.Results and limitationsSignificantly more patients treated with the terpene combination were stone free at the end of the study compared to placebo (intention-to-treat [ITT]—verum vs placebo: 72 patients [67.9%] vs 49 patients [50.0%]; p = 0.0009; per-protocol [PP]—verum vs placebo: 69 patients [78.4%] vs 48 patients [52.2%]; p = 0.0004). The treatment was even more effective when analyzed with respect to the size of the treated stone. In addition, the terpene combination treatment significantly reduced the median time to stone-free status (ITT—placebo vs verum: 85.0 d vs 56.0 d; p = 0.0061; PP—placebo vs verum: 85.0 d vs. 49.5 d; p = 0.0028). Tolerability was excellent.ConclusionsThe terpene combination Rowatinex^® was found to be an efficacious, well-tolerated, and safe treatment for eliminating calculi fragments generated by ESWL compared to placebo.     

Use of Noninvasive Interactive Neurostimulation to Improve Short-Term Recovery in Patients with Surgically Repaired Bimalleolar Ankle Fractures: A Prospective,Randomized Clinical Trial

We undertook a trial with 60 patients who had undergone operative reduction and internal fixation of bimalleolar, AO type B2 ankle fractures with comminution. Patients were randomized into 2 groups, one of which received postoperative treatment using a noninvasive interactive neurostimulation device (InterX^®) and the other with a sham device. The trial was designed to test the hypothesis that incorporation of noninvasive interactive neurostimulation into the rehabilitation protocol would result in reduced pain, increased range of motion, reduced edema, and reduced consumption of pain medication, in comparison with the sham therapy group. Outcome measurements included the patient's subjective assessment of level of pain, range of motion, and the extent of edema in the involved ankle, and the use of ketorolac for postoperative control of pain. The results showed significantly better results in the patients receiving treatment with active neurostimulation (repeated measures analysis of variance, P < .001).     

Clinical Evaluation of Fibrin Glue in the Prevention of Anastomotic Leak and Internal Hernia after Laparoscopic Gastric Bypass: Preliminary Results of a Prospective, Randomized Multicenter Trial

Background: Gastro-jejunal anastomotic leak and internal hernia can be life-threatening complications of laparoscopic Roux-en-Y gastric bypass (LRYGBP), ranging from 0.1-4.3% and from 0.8-4.5% respectively. The safety and efficacy of a fibrin glue (Tissucol^?) was assessed when placed around the anastomoses and over the mesenteric openings for prevention of anastomotic leaks and internal hernias after LRYGBP. Methods: A prospective, randomized, multicenter, clinical trial commenced in January 2004. Patients with BMI 40-59 kg/m², aged 21-60 years, undergoing LRYGBP, were randomized into: 1) study group (fibrin glue applied on the gastro-jejunal and jejuno-jejunal anastomoses and the mesenteric openings); 2) control group (no fibrin glue, but suture of the mesenteric openings). 322 patients, 161 for each arm, will be enrolled for an estimated period of 24 months. Sex, age, operative time, time to postoperative oral diet and hospital stay, early and late complications rates are evaluated. An interim evaluation was conducted after 15 months. Results: To April 2005, 204 patients were randomized: 111 in the control group (mean age 39.0±11.6 years, BMI 46.4±8.2) and 93 in the fibrin glue group (mean age 42.9±11.7 years, BMI 46.9±6.4). There was no mortality or conversion in both groups; no differences in operative time and postoperative hospital stay were recorded. Time to postoperative oral diet was shorter for the fibrin glue group (P=0.0044). Neither leaks nor internal hernias have occurred in the fibrin glue group. The incidence of leaks (2 cases, 1.8%) and the overall reoperation rate were higher in the control group (P=0.0165). Conclusion: The preliminary results suggest that Tissucol^? application has no adverse effects, is not time-consuming, and may be effective in preventing leaks and internal hernias in morbidly obese patients undergoing LRYGBP.     

A Study of Fecal Incontinence in Patients with Chronic Anal Fissure: Prospective,Randomized, Controlled Trial of the Extent of Internal Anal Sphincter Division During Lateral Sphincterotomy

Background Troublesome fecal incontinence following a lateral internal sphincterotomy is often attributed to faulty surgical technique. However, it may be associated with coexisting occult sphincter defects. Whether continence is related to the extent of sphincterotomy remains debatable. The aim of the study is to identify fecal incontinence related to chronic anal fissure before and after lateral internal sphincterotomy and its relationship to the extent of internal anal sphincter division. Methods One hundred eight patients with chronic anal fissure were prospectively studied before and after lateral internal sphincterotomy. A questionnaire was completed for each patient before and after surgery with regard to any degree of fecal incontinence. Fecal incontinence severity index was assessed using the Cleveland Clinic Incontinence Score. The patients with preoperative perfect continence were randomized into two groups (46 patients in each group): Group 1 underwent traditional lateral internal sphincterotomy (up to the dentate line) and Group 2 were underwent a conservative internal anal sphincterotomy (up to the height of the fissure apex or just below it). Results Minor degrees of incontinence were present before surgery in 16 patients (14.8%). Results of the randomized trial revealed that temporary postoperative incontinence was newly developed in 6/92 of patients (6.52 %) who did not have it before surgery. Five of the six (10.86%) were in Group 1 one (2.17%) was in Group 2 (p = 0.039). Persistent incontinence occurred in two in Group 1 (4.35%). All of them were females. All have had a history of one or more vaginal deliveries. Conclusion A mild degree of fecal incontinence may be associated with chronic anal fissure at presentation rather than as a result of internal sphincterotomy. Troublesome fecal incontinence after lateral internal sphincterotomy is uncommon. Sphincterotomy up to the dentate line provided faster pain relief and faster anal fissure healing, but it was associated with a significant postoperative alteration in fecal incontinence than was sphincterotomy up to the fissure apex. Care should be exercised in female patients with a history of previous obstetric trauma, as internal anal sphincter division may further compromise sphincter function.     

Is Laparoscopic Duodenojejunal Bypass with Sleeve an Effective Alternative to Roux En Y Gastric Bypass in Morbidly Obese Patients: Preliminary Results of a Randomized Trial

Background  

The incidence of obesity and related metabolic disorders in India and that of stomach carcinoma is one of the highest in the world. Hence, one requires a procedure that allows postoperative surveillance of the stomach with the best outcomes in terms of weight control and resolution of co-morbidities. Here, we compare one such procedure, duodenojejunal bypass with sleeve against the standard Roux-en Y gastric bypass.     

Clinical and Anatomical Outcomes of Arthroscopic Repair of Large Rotator Cuff Tears with Allograft Patch Augmentation: A Prospective,Single-Blinded,Randomized Controlled Trial with a Long-term Follow-up

BackgroundArthroscopic rotator cuff repair using human dermal matrix allograft augmentation has been widely used. We assessed the effect of acellular human dermal matrix augmentation after arthroscopic repair of large rotator cuff tears through a prospective, single-blinded, randomized controlled trial with a long-term follow-up.MethodsSixty patients with large-sized rotator cuff tears were randomly assigned to two groups. Patients in the control group underwent arthroscopic rotator cuff repair. Allograft patch augmentation was additionally performed in the allograft group. All patients were subdivided into a complete coverage (CC) group or an incomplete coverage (IC) group according to footprint coverage after cuff repair. Constant and American Shoulder and Elbow Surgeons (ASES) scores were assessed preoperatively and at final follow-up. Magnetic resonance imaging was also performed at the same time to evaluate the anatomical results.ResultsForty-three patients were followed up for an average of 5.7 years. Clinical scores (Constant and ASES) increased significantly at the last follow-up in both groups. The increase in ASES score in the allograft group was statistically significantly greater than that in the control group. The degree of Constant score improvement did not differ significantly between the two groups. The retear rate was 9.1% in the allograft group, which was significantly lower than that in the control group (38.1%). In the control group, the CC subgroup had a statistically significantly lower retear rate (16.7%) than did the IC subgroup. There were no retear cases in the CC subgroup of the allograft group.ConclusionsLong-term follow-up of arthroscopic repair of large rotator cuff tears with allograft patch augmentation showed better clinical and anatomical results. Footprint coverage after rotator cuff repair was an important factor affecting the retear rate. If the footprint was not completely covered after rotator cuff repair, allograft patch augmentation may reduce the retear rate.     

Effect on Survival of Androgen Deprivation Therapy Alone Compared to Androgen Deprivation Therapy Combined with Concurrent Radiation Therapy to the Prostate in Patients with Primary Bone Metastatic Prostate Cancer in a Prospective Randomised Clinical Trial: Data from the HORRAD Trial

Background

The cornerstone of standard treatment for patients with primary bone metastatic prostate cancer (mPCa) is androgen deprivation therapy (ADT). Retrospective studies suggest a survival benefit for treatment of the primary prostatic tumour in mPCa, but to date, no randomised-controlled-trials (RCTs) have been published addressing this issue.