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In this randomized trial, the clinical efficacy of an oral, live pentavalent human–bovine reassortant vaccine was estimated to be 98.0 percent against severe gastroenteritis due to rotavirus. In the safety study, which included 68,038 infants, the rates of intussusception were similar in the vaccine and placebo groups (relative risk, 0.8; 95 percent confidence interval, 0.3 to 1.8). In this randomized trial, the clinical efficacy of an oral, live pentavalent human–bovine reassortant vaccine was estimated to be 98.0 percent against severe gastroenteritis due to rotavirus. Rotavirus is the leading cause of hospitalization and death from acute gastroenteritis among infants and young children worldwide. More than 2 million hospitalizations and nearly half a million deaths are attributed to this infection annually. 1 , 2 The strategy of preventing rotavirus through vaccination derives from studies demonstrating that wild-type rotavirus infection induces immunity against subsequent rotavirus gastroenteritis. 3 – 6 Primary rotavirus infection provides substantial protection against gastroenteritis caused by the same serotype and against severe disease regardless of serotype. The four most prevalent serotypes, which account for more than 80 percent of cases of human rotavirus disease worldwide, are G1P[8], G2P[4], . . .

In this double-blind trial, two oral doses of a live attenuated G1P[8] rotavirus vaccine were highly efficacious in protecting infants against severe diarrheal disease. During the active surveillance of 63,225 infants, the risk of intussusception was no greater after vaccination than it was with placebo (six cases vs. seven cases). In this double-blind trial, two oral doses of a live attenuated G1P[8] rotavirus vaccine were highly efficacious in protecting infants against severe diarrheal disease. Rotavirus is the leading recognized cause of diarrhea-related illness and death among infants and young children. 1 – 5 Every year, rotavirus is associated with 25 million clinic visits, 2 million hospitalizations, and more than 600,000 deaths worldwide among children younger than five years of age. 6 , 7 Development of a safe and effective rotavirus vaccine is therefore a high priority, particularly but not exclusively in developing countries, where the burden of disease is highest. 8 , 9 Since the withdrawal from the market of the tetravalent rhesus–human reassortant vaccine (RotaShield, Wyeth Laboratories) because of an association with intussusception, 10 , 11 ruling out such a risk . . .

Purpose This study was aimed to compare the success rate between patients who underwent general anesthesia and deep sedation. Methods Patients who were diagnosed with intussusception and had no contraindications would receive non-operative treatment first by undergoing pneumatic reduction. The patients were then split in to two groups: one group underwent general anesthesia (GA group), while the other underwent deep sedation (SD group). This study was a randomized controlled trial which compared success rate between two groups. Results A total of 49 episodes diagnosed with intussusception were random into 25 episodes in GA group and 24 episodes in SD group. There was no significant difference in baseline characteristic between the two groups. The success rates of GA group and SD group were equally 88.0% ( p = 1.00). Sub-analysis of the success rate was lower in the patients with high-risk score for failed reduction. (Chiang Mai University Intussusception (CMUI) failed score in success VS failed = 6.9 ± 3.2 vs. 10.3 ± 3.0 p  = 0.017). Conclusion General anesthesia and deep sedation offered similar success rates. In cases of high risk of failure, general anesthesia should be considered to accommodate the switch to surgical management in the same setting if the non-operative approach fails. The appropriate treatment and sedative protocol also increase the success of reduction.

A randomised trial was undertaken to compare the clinical and functional results of two novel transanal stapled techniques in patients with outlet obstruction syndrome. Ninety-six females with outlet obstruction were treated with medical therapy and biofeedback for 2 months; 67 non-responders were evaluated by the Constipation Scoring and Continence Grading Systems, clinical examination, endoscopy, dynamic defecography, anorectal manometry, transanal ultrasound and anal EMG, and 50 of them, all affected with descending perineum, intussusception and rectocele, were randomly assigned to two groups and operated on: 25 patients (mean age 53.2+/-15.3 years) underwent a single Stapled Trans-Anal Prolapsectomy, associated with Perineal Levatorplasty (STAPL Group), and the other 25 (mean 54.6+/-14.2 years) underwent a double Stapled Trans-Anal Rectal Resection (STARR Group). Patients were followed-up for a mean period of 23.4+/-5.1 months in STAPL Group and 22.3+/-4.8 in STARR Group. STARR Group showed a significantly (p<0.0001) lower pattern of postoperative pain and a greater decrease (P=0.0117) of the rectal sensitivity threshold volume; otherwise, no differences were found in operative time, hospital stay, or time of inability to work. Complications included delayed healing of the perineal wound (ten), dyspareunia (five), urinary retention (two) and stenosis (one) in STAPL Group, and urge to defecate (four), transitory incontinence to flatus (two), urinary retention (two), bleeding (one) and stenosis (one) in STARR Group. All constipation symptoms significantly improved without worsening of anal continence and with excellent/good outcome at 20 months in 76 and 88% of patients of STAPL Group and STARR Group, respectively. Seven patients of STAPL Group had a little residual rectocele, while both intussusception and rectocele were corrected in all patients of STARR Group. Neither operation modified anal pressures or caused lesions of anal sphincters. Both techniques are safe and effective in the treatment of outlet obstruction; nevertheless, the double Stapled Trans-Anal Rectal Resection seems to be preferable due to less pain, absence of dyspareunia, reduced rectal sensitivity threshold volume and absence of residual rectocele at defecography.

BackgroundLive oral rhesus–rhesus-human rotavirus reassortant tetravalent (RRV-TV) vaccine was efficacious against rotavirus gastroenteritis but was withdrawn because of a rare association with intussusception. A corresponding tetravalent (types G1, G2, G3, and G4) reassortant vaccine based on bovine-human (UK) rotavirus reassortant tetravalent (BRV-TV) vaccine was developed concurrently MethodsBefore the withdrawal of RRV-TV vaccine, parallel placebo-controlled trials of BRV-TV vaccine (observer blinded) versus RRV-TV vaccine (double blinded) with a 2:1 ratio of vaccine:placebo were conducted in Finland in a total of 510 infants. Two doses of study vaccine or placebo were administered at ages 3 and 5 months ResultsThe first dose of RRV-TV vaccine was followed by a significant excess rate of febrile reactions (36%), whereas the rate of fever after the administration of BRV-TV vaccine did not differ significantly from that in the placebo group. Neither vaccine induced diarrhea. A seroresponse was detected in 97% of BRV-TV vaccine recipients and 94% of RRV-TV vaccine recipients. Both vaccines were equally effective, with 68%–69% efficacy against any and 88%–100% efficacy against severe rotavirus gastroenteritis during the first epidemic season ConclusionsBRV-TV vaccine is a promising new candidate rotavirus vaccine, with low reactogenicity and high efficacy. Two doses of BRV-TV or RRV-TV vaccine are sufficient for the induction of protection against severe rotavirus disease

Despite the benefits of rotavirus vaccination, concerns about intussusception are an important consideration. In this study, the risk of intussusception associated with rotavirus vaccination was assessed in African countries in which the vaccine had recently been rolled out.

Rotavirus vaccination has been associated with a decline in rotavirus-associated illness, but intussusception remains a concern. In this study, the pentavalent rotavirus vaccine was associated with a slight increase in intussusception, as compared with the monovalent vaccine. In 1999, a tetravalent rhesus–human reassortant rotavirus vaccine (RotaShield, Wyeth Lederle) was voluntarily withdrawn from the U.S. market within a year after licensure owing to an association with intussusception. The excess risk of intussusception was estimated at approximately 1 to 2 cases per 10,000 recipients of the vaccine. 1 In 2006 and 2008, respectively, a pentavalent bovine–human reassortant rotavirus vaccine (RV5; RotaTeq, Merck) and a monovalent human rotavirus vaccine (RV1; Rotarix, GlaxoSmithKline) were licensed after evaluation in clinical trials involving more than 60,000 infants, which provided enough statistical power to allow detection of an intussusception risk of a magnitude similar to . . .

This report showed that the occurrence of intussusception after routine infant rotavirus vaccinations in Mexico and Brazil was approximately 1 in 51,000 to 1 in 68,000 infants. This should be considered in light of the estimated number of hospitalizations and deaths averted. In 1999, a rotavirus vaccine (Rotashield, Wyeth Laboratories) was withdrawn from the market in the United States because it was associated with intussusception, a form of bowel obstruction. 1 The risk was greatest (an increase by a factor of approximately 37) during the period 3 to 7 days after the first dose was administered, correlating with the peak period of replication of the vaccine virus in the intestines, and translated to an excess of approximately 1 case of intussusception in 10,000 recipients of RotaShield. 1 , 2 Because of this association, two clinical trials, each of which involved more than 60,000 infants, evaluated . . .

Background Adult small-bowel intussusception (ASI) is a rare condition with pathological etiologies in most patients. Previously, surgical intervention was the primary treatment modality; however, the introduction of balloon-assisted enteroscopy (BAE) has allowed preoperative BAE in some cases to confirm the leading point, thereby guiding management and reducing surgical need. In this study, we investigated whether the introduction of BAE has altered the diagnostic and therapeutic strategies for ASI by retrospectively analyzing and comparing the clinicopathological features of patients before and after its introduction. Methods Fifty-three patients with ASI, initially diagnosed via abdominal computed tomography scanning at Korea University Guro Hospital from 2000 to 2023, were included in our study. Patients were grouped based on double-balloon enteroscopy (DBE) usage, and clinicopathological outcomes were compared retrospectively. Results Of the 53 patients, 38 (71.7%) had enteroenteric-type intussusception and 15 (28.3%) had enterocolic-type intussusception. Among the patients with enteroenteric-type intussusception, 15.8% had a malignant cause, whereas in the enterocolic type, 60% had a malignant cause ( p  = 0.001). Of 38 patients with enteroenteric ASI, 15 (39.5%) underwent preoperative DBE. The surgical resection rate was significantly lower in the DBE group (40%) than in the non-DBE group (73.9%) ( p  = 0.037). Pathological diagnoses of patients who underwent surgical resection without preoperative DBE revealed 17.6% malignancies and 82.4% benign causes, including idiopathic intussusception (four cases) and Peutz–Jeghers syndrome (two cases). No morbidity, mortality, or recurrence was observed. Conclusion Preoperative BAE is a valuable diagnostic and therapeutic modality for ASI, particularly in cases of low-grade small-bowel obstruction, reducing surgical resection rates in most ASI cases. The introduction of the BAE has significantly improved ASI management, achieving high successful reduction rates and few surgical interventions. BAE should be considered a first-line diagnostic and therapeutic tool for ASI management.

In Europe, rotavirus gastroenteritis is associated with a significant health, economic and social burden, as it is responsible for large numbers of hospitalizations and other healthcare encounters among infants and children, as well as numerous days of work lost by parents and caregivers. RotaTeq® is a three-dose, orally administered, live, pentavalent human-bovine reassortant rotavirus vaccine used for the active immunization of infants for prevention of rotavirus gastroenteritis. The protective efficacy of RotaTeq® has been evaluated in terms of its effects on the incidence of rotavirus gastroenteritis and on healthcare resource use. Clinical trial data from REST (a randomized, double-blind, placebo-controlled, multinational study in ≈70 000 healthy infants aged 6–12 weeks) and various subgroup analyses, including a large European cohort, have shown that RotaTeq® may be administered at the same time as various other routine vaccines, has high and sustained efficacy covering the main period of risk for rotavirus gastroenteritis, has early protective efficacy after the first and second doses, reduces rotavirus gastroenteritis-associated hospitalization and emergency department and physician visits, and is generally well tolerated. Moreover, RotaTeq® has demonstrated efficacy against the five most prevalent serotypes of rotavirus in Europe (G1–G4, G9), in terms of reductions in associated healthcare resource use. There is also evidence that the widespread use of RotaTeq® may provide herd immunity, as it appears to have indirect benefits in older, unvaccinated children. Reports on the ‘real world’ effectiveness of RotaTeq® in Europe are just emerging, but data from the US have shown a rapid and marked reduction in rotavirus burden nationwide during the ≈2-year period following the introduction of RotaTeq® and the subsequent availability of official recommendations advocating universal use of the vaccine as part of routine childhood immunization. Similar benefits have also been demonstrated in Australia after the introduction of a publicly funded rotavirus vaccination programme. Postmarketing surveillance data from the US have not identified any concerns, such as an association with intussusception or Kawasaki disease, related to the safety of RotaTeq®. In conclusion, RotaTeq® is a generally well tolerated vaccine that has efficacy against the five most prevalent serotypes of rotavirus in Europe and provides sustained efficacy over the main risk period for rotavirus gastroenteritis in infants and children, reducing hospitalizations and emergency department visits by decreasing the incidence and severity of illness.