A randomized, controlled, clinical study of laparoscopic vs open tension-free inguinal hernia repair

BACKGROUND: The aim of this prospective, randomized, controlled clinical study was to compare laparoscopic transabdominal preperitoneal (TAPP) hernia repair with a standard tension-free open mesh repair (open). METHODS: A total of 108 low-risk patients with unilateral (primary or recurrent) or bilateral hernias were randomized to TAPP (group 1 = 52 cases) or open (group 2 = 56 cases). The outcome measures included operating time, complications, postoperative pain, return to normal activity, operating theater costs, and recurrences. RESULTS: The mean operative time was longer for the TAPP than for the open group only in unilateral primary hernias. At rest, the median Visual Analog Scale (VAS) score was higher for group 1 than group 2 at 48 h postoperatively. Mild to discomforting pain in the inguinal region after 7 days, night pain after 30 days, and inguinal hardening after 3 months were more frequent in group 2 than group 1. No significant differences were observed in return to normal activities between the groups. One hernia recurrence was observed after 1 month in group 1. TAPP was significantly more expensive than open. CONCLUSIONS: TAPP was associated with less postoperative pain than open. The increase in operating theater costs, however, was dramatic and was not compensated by shorter time away from work. TAPP should not be adopted routinely unless its costs can be drastically reduced.     

A prospective, randomized trial comparing laparoscopic versus conventional techniques in colorectal cancer surgery: a preliminary report

BACKGROUND: Uncontrolled studies using laparoscopic techniques in colorectal surgery have not demonstrated clear advantages to these procedures compared with conventional ones, and surgeons are concerned about unusual early recurrences reported after laparoscopic colorectal cancer surgery. STUDY DESIGN: We conducted a prospective, randomized trial in one surgical department comparing laparoscopic (LAP) and conventional (CON) techniques in 109 patients undergoing bowel resection for colorectal cancers or polyps. Postoperatively, all patients underwent measurement of pulmonary function tests every 12 hours, and were treated identically on a highly controlled protocol with regard to analgesic administration, feeding, and postoperative care. RESULTS: Of the 55 patients assigned to LAP and 54 to the CON group, there were 42 and 38 with cancer, respectively (the other patients had large adenomas). Overall recovery of 80% of forced expiratory volume in 1 second and forced vital capacity was a median of 3 days for LAP and 6.0 days for CON (p = 0.01). LAP patients used significantly less morphine than CON patients up to the second day after surgery (0.78 +/- 0.32 versus 0.92 +/- 0.34 mg/kg per day, p = 0.02). Flatus returned a median of 3.0 days after LAP versus 4.0 days after CON surgery (p = 0.006). Tumor margins were clear in all patients. After a median followup of 1.5 years (LAP) and 1.7 years (CON), there were no port site recurrences in the LAP group. Seven cancer-related deaths have occurred (three in the LAP group, four in the CON group). CONCLUSIONS: Within this prospective, randomized trial, laparoscopic techniques were as safe as conventional surgical techniques and offered a faster recovery of pulmonary and gastrointestinal function compared with conventional surgery for selected patients undergoing large bowel resection for cancer or polyps. There were no apparent shortterm oncologic disadvantages. Longer followup is needed to fully assess oncologic outcomes.     

Postoperative pain and fatigue after laparoscopic or conventional colorectal resections. A prospective randomized trial

BACKGROUND: Conventional colorectal resections are associated with severe postoperative pain and prolonged fatigue. The laparoscopic approach to colorectal tumors may result in less pain as well as less fatigue, and may improve postoperative recovery after colorectal resections. METHODS: Sixty patients were included into a prospective randomized trial to determine the influence of laparoscopic (n = 30) or conventional (n = 30) resection of colorectal tumors on postoperative pain and fatigue. Major endpoints of the study were dose of morphine sulfate during patient-controlled analgesia (PCA), visual analog scale for pain while coughing (VASC), and visual analogue scale for fatigue (VASF). Efficacy of pain medication was assessed by visual analogue score at rest (VASR). RESULTS: Preoperative age, sex, stage, and localization of tumors were comparable in both groups. The PCA dose of morphine given immediately after surgery until postoperative day 4 was higher in the conventional group (median, 1.37 mg/kg; 5-95 percentile 0.71-2. 46 mg/kg) than the laparoscopic group (0.78 mg/kg; 0.24-2.38 mg/kg, p < 0.01). Postoperative VASR was comparable between both groups, but VASC was higher from the first to the seventh postoperative day (p < 0.01). Postoperative fatigue was higher after conventional than after laparoscopic surgery from the second to the seventh day (p < 0. 05). CONCLUSIONS: This study confirms that analgetic requirements are lower and pain is less intense after laparoscopic than after conventional colorectal resection. Patients also experience less fatigue after minimal invasive surgery. Because of these differences, the duration of recovery is shortened, and the postoperative quality of life is improved after laparoscopic colorectal resections.     

Follow-up after inguinal hernia repair. Questionnaire compared with physical examination: a prospective study in 299 patients

OBJECTIVE: To assess the value of a written questionnaire in the follow-up of patients after inguinal hernia repair. DESIGN: Prospective study. SETTING: University and two district hospitals. The Netherlands. SUBJECTS: 314 patients with 362 inguinal hernias. MAIN OUTCOME MEASURES: Correlation between answers to questionnaire and clinical examination in the diagnosis of recurrent hernias. RESULTS: 13/24 recurrences (54%) after a mean follow-up of 33 months with a follow-up rate of 93% were not diagnosed by the questionnaire. CONCLUSION: Follow-up after hernia repair must be by physical examination.     

Reducing the period of immobilization following pressure sore surgery: a prospective, randomized trial

The primary structures of two subunits of an alpha-amylase inhibitor (alpha AI-2) from a wild common bean (Phaseolus vulgaris) were revealed by a comparison of the amino acid sequence previously deduced from the nucleotide sequence with the amino- and carboxyl-terminal amino acid sequences determined by conventional methods. The polypeptide molecular weight of alpha AI-2 obtained by the light-scattering technique, considered together with the sequence molecular weights revealed for the subunits, indicated that alpha AI-2 has the subunit stoichiometry of an alpha 2 beta 2 complex. These structural features were closely similar to those recently elucidated for a white kidney bean (P. vulgaris) alpha-amylase inhibitor, which is quite different in the inhibitory specificity from alpha AI-2. The post-translational processing of the precursor glycoproteins to form the tetrameric structure appeared to require an Arg residue close to the processing site. Further, the proper associations of the subunits into the tetrameric structures seemed to be strictly controlled by a few amino acids on the subunit interfaces.     

Prophylactic iron supplementation after Roux-en-Y gastric bypass: a prospective, double-blind, randomized study

OBJECTIVE: To determine whether prophylactic oral iron supplements (320 mg twice daily) would protect women from iron deficiency and anemia after Roux-en-Y gastric bypass. DESIGN: Prospective, double-blind, randomized study in which 29 patients received oral iron and 27 patients received a placebo beginning 1 month after Roux-en-Y gastric bypass. SETTING: Tertiary care medical center. PATIENTS AND INTERVENTIONS: Complete blood cell count and serum levels of iron, total iron binding capacity, ferritin, vitamin B12, and folate were determined preoperatively and at 6-month intervals postoperatively in 56 menstruating women who had Roux-en-Y gastric bypass. MAIN OUTCOME MEASURE: Incidence of iron deficiency and other hematological abnormalities in each treatment group. RESULTS: Hemoglobin, hematocrit, and vitamin B12 levels were significantly decreased compared with preoperative values in both groups. Conversely, folate levels increased significantly over time in both groups. Oral iron consistently prevented development of iron deficiency in the iron group. Ferritin levels did not change significantly in the iron group. However, in placebo-treated patients, ferritin levels 2 years postoperatively were significantly decreased compared with preoperative levels. There was no difference in the incidence of anemia between the 2 groups. However, the incidence of microcytosis was substantially greater (P=.07) in placebo-treated than iron-treated patients. CONCLUSIONS: Prophylactic oral iron supplements successfully prevented iron deficiency in menstruating women after Roux-en-Y gastric bypass but did not consistently protect these women from developing anemia. On the basis of these results we now routinely recommend prophylactic iron supplements to menstruating women who have Roux-en-Y gastric bypass.     

Early active training after lumbar discectomy. A prospective, randomized, and controlled study

STUDY DESIGN: A prospective, randomized, and controlled study was conducted. OBJECTIVES: To evaluate two training programs, both of which started immediately after lumbar discectomy. SUMMARY OF BACKGROUND DATA: In previous studies, patients began physiotherapy between 4 weeks and 60 months after surgery. No studies have been conducted to evaluate a physiotherapy program that begins immediately after surgery. METHOD: Twenty-six patients were treated according to an early active training program. Twenty-six patients were treated with a traditional, less active training program (control group). All patients were examined immediately before and after surgery and 3, 6, 12, and 52 weeks after surgery by an unbiased observer. Two years after surgery, patients completed a questionnaire. Range of motion of the lumbar spine and straight leg raising were measured. pain intensity and location was measured by a visual analog scale. The duration of sick leave was documented. RESULTS: Six and 12 weeks after surgery, patients with dominating residual leg pain had significantly less intense pain in the early active training group than those in the control group (P < 0.05). Twelve weeks after surgery, range of motion of the lumbar spine was significantly more increased in the early active training group (P < 0.01). One year after surgery, there was no significant difference between the groups regarding the duration of sick leave, results in a positive straight leg raising, or pain intensity. Twenty-two (88%) patients in the early active training group and 16 (67%) in the control group were satisfied with the treatment outcome 2 years after surgery (P < 0.10). CONCLUSIONS: Patients rehabilitated according to the early active training program had a better short-term outcome of objective values. At 2 years' follow-up, more patients were satisfied with the result of the operation. The early active treatment program is recommended.     

Dexamethasone decreases the incidence of shivering after cardiac surgery: a randomized, double-blind, placebo-controlled study

Shivering after cardiac surgery is common, and may be a result of intraoperative hypothermia. Another possible etiology is fever and chills secondary to activation of the inflammatory response and release of cytokines by cardiopulmonary bypass. Dexamethasone decreases the gradient between core and skin temperature and modifies the inflammatory response. The goal of this study was to determine whether dexamethasone can reduce the incidence of shivering. Two hundred thirty-six patients scheduled for elective coronary and/or valvular surgery were randomly assigned to receive either dexamethasone 0.6 mg/kg or placebo after the induction of anesthesia. All patients received standard monitoring and anesthetic management. After arrival in the intensive care unit (ICU), nurses unaware of the treatment groups recorded visible shivering, as well as skin and pulmonary artery temperatures. Analysis of shivering rates was performed by using chi2 tests and logistic regression analysis. Compared with placebo, dexamethasone decreased the incidence of shivering (33.0% vs 13.1%; P = 0.001). It was an independent predictor of reduced incidence of shivering and was also associated with a higher skin temperature on ICU admission and a lower central temperature in the early postoperative period. IMPLICATIONS: Dexamethasone is effective in decreasing the incidence of shivering. The effectiveness of dexamethasone is independent of temperature and duration of cardiopulmonary bypass. Shivering after cardiac surgery may be part of the febrile response that occurs after release of cytokines during cardiopulmonary bypass.     

The effects of self-hypnosis on quality of life following coronary artery bypass surgery: preliminary results of a prospective, randomized trial

The effects of complementary techniques and alternative medicine on allopathic therapies is generating much interest and research. To properly evaluate these techniques, well controlled studies are needed to corroborate the findings espoused by individuals practicing complementary medicine therapies. To this end, we evaluated the role of one of these therapies, self-hypnosis relaxation techniques, in a prospective, randomized trial to study its effects on quality of life after coronary artery bypass surgery. Subjects were randomized to a control group or a study group. Study group patients were taught self-hypnosis relaxation techniques the night prior to surgery. The control group received no such treatment. Patients then underwent routine cardiac management and care. The main endpoint of our study was quality of life, assessed by the Profile of Moods Scale. Results demonstrated that patients undergoing self-hypnosis the night prior to coronary artery bypass surgery were significantly more relaxed than the control group (p = 0.0317). Trends toward improvement were also noted in depression, anger, and fatigue. This study demonstrates the beneficial effects of self-hypnosis relaxation techniques on coronary surgery. This study also identifies endpoints and a study design that can be used to assess complementary medicine therapies. Results of this preliminary investigation are encouraging and demonstrate a need for further well-controlled studies.     

Prevention of supraventricular tachyarrhythmias after open heart operation by low-dose sotalol: a prospective, double-blind, randomized, placebo-controlled study

BACKGROUND: The aim of this prospective, double-blind, placebo-controlled trial was to assess the preventive effect and safety of low-dose sotalol after heart operation. METHODS: Two hundred fifty-five consecutive patients referred for elective coronary artery bypass grafting (n = 220) or aortic valve operation (n = 35) were randomized to receive either 80 mg of sotalol twice daily (n = 126) or matching placebo (n = 129) for 3 months, with the first dose given 2 hours before operation. RESULTS: There were no significant baseline differences between the groups. Overall, supraventricular tachyarrhythmias occurred in 36% of patients (82% atrial fibrillation). Hospital stay was 11.6 +/- 5 days in patients with supraventricular arrhythmias, versus 9.5 +/- 2.4 days in patients without it (p < 0.0001). Low-dose sotalol reduced the rate of supraventricular arrhythmias from 46% (placebo) to 26% (sotalol; p = 0.0012), or by 43%. On the fourth postoperative day, heart rate was lower in the sotalol group (74 +/- 12 beats/min versus 85 +/- 15 beats/min; p < 0.0001) but the QT interval corrected for the heart rate was not prolonged (sotalol group, 0.44 +/- 0.03 second; placebo group, 0.43 +/- 0.03 second; p = not significant). Study medication had to be discontinued because of side effects in 5.6% of sotalol and 3.9% of placebo patients (p = not significant), with one possible proarrhythmic event occurring in a patient receiving sotalol. CONCLUSIONS: Because more than 90% of supraventricular arrhythmic episodes occurred within 9 days after operation and 70% of all possibly sotalol related side effects occurred after day 9, the findings in this study imply that prophylactic treatment with sotalol may be limited to the first 9 postoperative days.     

Neuropsychological course after surgery for intracranial aneurysms. A prospective study and a critical review

Two techniques for simultaneous detection and typing of plum pox potyvirus (PPV) isolates belonging to the D or M serotypes, heminested PCR (H-PCR) and PCR-ELISA, have been developed. Ten PPV isolates typed using PPV-D and PPV-M specific monoclonal antibodies by ELISA-DASI were used to validate these two methods. The results obtained show a complete coincidence of the nucleic acid-based techniques with the serological data. When serial dilutions of infected plant extracts were assayed, H-PCR and PCR-ELISA were found to be 100 times more sensitive than the more conventional immunocapture-PCR (IC-PCR) assay. Testing of 228 PPV-infected fruit tree samples coming from different hosts and locations indicated that so far only PPV type D appears to be present in Spain and in Chile. Coupled with print-capture sample preparation (Olmos et al., Nucl. Acids Res. 24, 2192-2193, 1996) the increased sensitivity provided by heminested-PCR allowed the detection of PPV targets of D and M types, in wingless individuals of the aphid vector Aphis gossypii.     

Ondansetron for prevention of postoperative nausea and vomiting following minor oral surgery: a double-blind randomized study

The efficacy and safety of ondansetron in preventing postoperative nausea and vomiting following minor oral surgery was evaluated in a prospective randomized double-blind study. Of a total of seventy-seven patients, randomly 38 had 4 mg of ondansetron and 39 had normal saline as placebo intravenously immediately prior to induction of anaesthesia. A standard general anaesthetic with thiopentone, suxamethonium, fentanyl, nitrous oxide and isoflurane was employed. Postoperatively nausea was assessed verbally and on a visual analog scale at 1, 4 and 24 hours from the time of awakening. Episodes of vomiting were recorded. Eight patients (21.1%) in the ondansetron group compared to 19 (48.7%) in the placebo group had nausea (P < 0.05) and 1 (2.6%) in the ondansetron group compared with 9 (23.1%) in the placebo group vomited (P < 0.05). Patients who vomited twice or more and the number who required a rescue antiemetic were significantly fewer in the ondansetron group (P < 0.05). Cardiovascular parameters were stable and showed no significant difference in the two groups. There were no significant adverse effects that could be directly attributable to ondansetron.     

Dilutional and modified ultrafiltration reduces pulmonary hypertension after operations for congenital heart disease: a prospective randomized study

OBJECTIVE: A prospective randomized study was performed to test whether removal of endothelin-1, by ultrafiltration techniques, will reduce pulmonary hypertension after operations for congenital heart disease. METHODS: Twenty-four patients with pulmonary hypertension (systolic pulmonary/systemic arterial pressure ratio > 60%) undergoing cardiac operations were randomized into a control group (n = 12) having conventional ultrafiltration and an experimental group (n = 12) undergoing dilutional ultrafiltration during and modified ultrafiltration after cardiopulmonary bypass. Plasma endothelin-1, nitric oxide metabolites, and cyclic guanosine monophosphate were assayed before bypass, 10 minutes into bypass, after bypass, and 0, 3, 6, and 12 hours after the operation in both groups, as well as in the ultrafiltrates and after modified ultrafiltration in the experimental group. Both groups received alpha-blockers (chlorpromazine and/or prazosin) postoperatively using the same guidelines. RESULTS: The ultrafiltrates contained significant amounts of endothelin-1 (1.81 +/- 0.86 pg/ml, dilutional, and 6.44 +/- 1.82 pg/ml, modified ultrafiltrate). Endothelin-1 and the pulmonary/systemic pressure ratio were significantly lower in experimental compared with control patients. Nitric oxide metabolites and cyclic guanosine monophosphate increased similarly in both groups for 12 hours after the operation (p = not significant). Three of 12 control patients (25%) but no experimental patients had pulmonary hypertensive crises (p = 0.07). The experimental patients required significantly less ventilatory support (67 +/- 47 hours vs 178 +/- 139 hours for control patients, p = 0.048). CONCLUSIONS: Dilutional and modified ultrafiltration reduce endothelin-1 and the pulmonary/systemic pressure ratio postoperatively and may become an important adjunct for preventing pulmonary hypertension after operations for congenital heart disease in high-risk patients.     

Quality of life aspects and costs in treatment of Graves'' hyperthyroidism with antithyroid drugs, surgery, or radioiodine: results from a prospective, randomized study

The influence of endocrine factors on colorectal tumor development remains unclear. We performed a meta-analysis of studies of the association between the use of menopausal hormones and colon cancer in women, published up to December 1996. We derived summary measures of relative risk (RR) by fitting both fixed and random effects models. We also performed analyses by tumor location to the right or left colon, as well as by recency and duration of use. Heterogeneity was assessed according to study design, chronology, or other criteria. Overall, the 20 independent estimates of the association between ever use of menopausal hormones and colon cancer led to a summary RR of 0.85, (0.73, 0.99), using a random effects model. There was substantial heterogeneity among studies. The suggested protective effect of hormones was estimated to be stronger in studies published since 1990 [RR: 0.83, (0.66, 1.04), versus 0.93, (0.78, 1.10), for those published previously]. The estimated RRs were lower among current or recent users [RR: 0.69, (0.52, 0.91)] and among users of more than 5 years [RR: 0.73, (0.53, 1.02)] as compared with short-term users [RR: 0.88, (0.64, 1.21)]. The current state of knowledge suggests a 0-25% risk reduction among ever users of hormone replacement therapy. Inadequate assessment of exposure, poor control of confounding factors, and changing patterns of use over time might have contributed to the slow emergence of this association postulated almost two decades ago. Additional large studies are needed to replicate this finding and explain the exact mechanism of this putative protective effect.     

Septic complications after biliary tract stone surgery: a review and report of the European prospective study

We report a prospective, controlled study of the incidence of septic complications following biliary tract stone surgery. This study included a total of 280 patients operated on in eight hospitals in various European countries. In this study the computer program "Surgery" was used. Of 280 patients, 77 (27.5%) were male and 203 (72.5%) were female. The age ranged from 20 to 92 years (mean 54.8 years); 78.9% of the cases corresponded to clean-contaminated surgery; 85% of the patients received antibiotic prophylaxis with cefazolin. Twenty-one patients developed postoperative septic complications (7.5%) of which 12 (4.3%) were wound infections; five patients (1.8%) had intra-abdominal infections. The wound infection rate was 3.2% in clean-contaminated surgery, 7.7% in contaminated and 20% in dirty (p < 0.02). In laparoscopic cholecystectomy the global rate of septic complications was 3.6% vs. 12.6% in open cholecystectomy (p < 0.01); 2.4% and 6.3% wound infection respectively. The mean age of patients who developed postoperative septic complications was 61.5 years and 54.2 years old who did not develop any complications (p < 0.03). The duration of the postoperative period was 5 days in patients without infection and 13 days in patients with infection (p < 0.0001). Two patients died, one of them (0.4%) caused by sepsis. In addition to the European prospective study, a review of the problems of sepsis in biliary surgery was carried out.     

Early tracheal extubation after coronary artery bypass graft surgery reduces costs and improves resource use. A prospective, randomized, controlled trial

BACKGROUND: Economics has caused the trend of early tracheal extubation after cardiac surgery, yet no prospective randomized study has directly validated that early tracheal extubation anesthetic management decreases costs when compared with late extubation after cardiac surgery. METHODS: This prospective, randomized, controlled clinical trial was designed to evaluate the cost savings of early (1-6 h) versus late tracheal extubation (12-22 h) in patients after coronary artery bypass graft (CABG) surgery. The total cost for the services provided for each patient was determined for both the early and late groups from hospital admission to discharge home. All costs applicable to each of the services were classified into direct variables, direct fixed costs, and overhead (an indirect cost). Physician fees and heart catheterization costs were included. The total service cost was the sum of unit workload and overhead costs. RESULTS: One hundred patients having elective CABG who were younger than 75 yr were studied. Including all complications, early extubation (n = 50) significantly reduced cardiovascular intensive care unit (CVICU) costs by 53% (P < 0.026) and the total CABG surgery cost by 25% (P < 0.019) when compared with late extubation (n = 50). Forty-one patients (82%) in each group were tracheally extubated within the defined period. In the early extubation group, the actual departmental cost savings in CVICU nursing and supplies was 23% (P < 0.005), in ward nursing and supplies was 11% (P < 0.05), and in respiratory therapy was 12% (P < 0.05). The total cost savings per patient having CABG was 9% (P < 0.001). Further cost savings using discharge criteria were 51% for CVICU nursing and supplies (P < 0.001), 9% for ward nursing and supplies (P < 0.05), and 29% for respiratory therapy (P < 0.001), for a total cost savings per patient of 13% (P < 0.001). Early extubation also reduced elective case cancellations (P < 0.002) without any increase in the number of postoperative complications and readmissions. CONCLUSIONS: Early tracheal extubation anesthetic management reduces total costs per CABG surgery by 25%, predominantly in nursing and in CVICU costs. Early extubation reduces CVICU and hospital length of stay but does not increase the rate or costs of complications when compared with patients in the late extubation group. It shifts the high CVICU costs to the lower ward costs. Early extubation also improves resource use after cardiac surgery when compared with late extubation.     

The use of cold therapy after anterior cruciate ligament reconstruction. A prospective, randomized study and literature review

We performed a randomized, prospective study to assess the effectiveness of postoperative cold therapy in patients who had anterior cruciate ligament reconstructions. Drain output, length of hospital stay, range of motion, and use of pain medication were all assessed. Patients were randomized into one of four groups after surgery. Group 1 patients had a cooling pad applied to the knee postoperatively and set at a temperature of 40 degrees to 50 degrees F, Group 2 had the cooling pad set at 70 degrees to 80 degrees F, Group 3 received ice packs, and Group 4 received no cold therapy of any kind. The skin temperatures in Groups 1 and 3 were significantly lower than the skin temperatures in Groups 2 and 4 (P < 0.001). The length of hospital stay, range of motion at discharge, use of oral and intramuscular pain medicine, and drain output were not significantly different between groups. No complications related to the type of cold therapy were seen in any group. Thus, both ice packs and cooling pads significantly decreased knee temperature, but we found no objective benefits in the early postoperative course due to this decrease in temperature.     

Adjuvant cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy after radiation therapy in stage I low-grade and intermediate-grade non-Hodgkin lymphoma. Results of a prospective randomized study

BACKGROUND: In a prospective randomized manner, this study evaluated the effect of adjuvant chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone; CHOP) in patients with Stage I non-Hodgkin lymphoma (NHL) who have achieved a complete response (CR) after radiation therapy (RT). METHODS: Forty-four patients with clinical or pathologic Stage I intermediate-grade or low-grade NHL were randomized to receive regional RT alone (median dose, 40 Gy) or regional RT followed by six cycles of CHOP chemotherapy. There were no differences in clinical and pathologic characteristics between the two treatment groups. RESULTS: The median follow-up was 7 years (range, 2-10 years). The actuarial relapse-free survival (RFS) rate for the RT plus CHOP group at 7 years was 83% compared with 47% (P < 0.03) for the RT-alone group. The overall survival (OS) for the two groups was 88% and 66%, respectively (P = 0.2). In patients with intermediate-grade NHL, the 7-year actuarial RFS for RT and CHOP was 86% compared with 20% for RT alone (P = 0.004). The corresponding actuarial survival rates were 92% and 47%, respectively (P = 0.08). In patients with low-grade histologic findings, the addition of adjuvant CHOP did not improve RFS (P = 0.6) or OS. All relapses in this study were at sites remote from the initially involved areas, and in 5 of 11 patients (45%), there were recurrences 5 years or longer after initial treatment. CONCLUSIONS: This study showed that adjuvant CHOP chemotherapy significantly improves RFS in patients with Stage I intermediate-grade NHL who achieve a CR after regional-field RT. The chemotherapeutic regimen favorably affected their probability of survival.     

Prevention of postoperative nausea and vomiting with ondansetron: a prospective, randomized, double-blind study in 90 patients

Cortical variation in mammals and other terrestrial vertebrates, re-examined by current comparative methodology (out-group analysis), indicates that separate lateral (olfactory), dorsal and medial (hippocampal) pallial or cortical formations arose with the origin of vertebrates. Although the exact origin of mammalian isocortex (so-called neocortex) is still disputed, it appears that the earliest mammals already had a six-layered isocortex with ten to 20 functional subdivisions. Among placental mammals, at least, isocortex has expanded numerous times, producing additional cortical subdivisions. Because these expansions were independent transformations of a simpler cortex, they produced subdivisions that are not homologous.