Active clinical trials for "Intussusception"

Background: Intussusception remains a common cause of bowel obstruction in children and results in significant morbidity and mortality if not promptly treated. There is a paucity of prospective studies regarding childhood intussusception. This study describes the seasonal variation and management outcomes of childhood intussusception. METHODS: This was A prospective study of all patients admitted and treated for childhood intussusception aged < 12 year intussusception from January 2014 to December 2018 was conducted in El-Minia University Pediatric surgery unit. Data about the ages of the patients, sex, clinical presentation, duration of symptoms before presentation, mode of treatment, outcome of treatment, and incidence of recurrence were recorded and analyzed.

This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.

Posterior compression - distraction reduction technique （CDR） in the treatment of Basilar invagination associated with atlantoaxial dislocation

Pediatric emergency medicine (PEM) physicians are increasingly utilizing point-of-care ultrasound (POCUS). There is currently limited data regarding POCUS evaluation for intussusception in pediatric patients. To better understand the role of POCUS for identification of intussusception, the investigators plan to conduct a randomized, noninferiority study comparing POCUS and radiology-performed ultrasound (RADUS), utilizing experienced sonographers across multiple institutions.

Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception. Our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.

Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.

Background: Five billion people worldwide do not have access to safe, affordable surgical care. A significant proportion live in sub-Saharan Africa (SSA), where up to 50% of the population are children. There is limited literature on neonatal and paediatric surgery in SSA and children's surgery does not appear on any of the National Health Strategic Plans for the 47 independent countries across SSA. Objectives: To form a collaboration of surgeons and allied health professionals involved in children's surgery across SSA and collectively undertake the largest prospective cohort study of paediatric surgery in this region. Materials and Methods: Data will be collected via REDCap website on all patients with gastroschisis, anorectal malformation, appendicitis, inguinal hernia and intussusception, during a 1-month period of collaborators choice between October 2016 to April 2017, with a 30-day follow up until the end of May 2017. Estimated study population: 1450 patients from 50 institutions. Full ethical approval has been granted by the host centre; local ethical approval will be required at collaborating centres for participation. All collaborators will be co-authors. Primary outcome will be in-hospital all-cause mortality. Secondary outcomes will include post-intervention complications. Data will be collected on institutional facilities, patient demographics, duration from condition onset to presentation, peri-operative resuscitation, intervention and outcome. Differences in outcomes between SSA and benchmark data from high-income countries will be calculated using chi-squared analysis. Multi-level multivariate logistic regression analysis will be used to identify interventions and peri-operative factors associated with improved outcomes; p<0.05 will be deemed significant. Outcome: Results will be used to advocate for enhanced children's surgical services in SSA. We shall identify context-appropriate interventions associated with improved outcome. The collaboration will help to enhance research capacity in the region.

GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describes a Phase IV safety study in Mexico designed to further evaluate the safety profile of Rotarix™ with regard to intussusception (IS). The data generated by this study will be useful for public health officers and policy makers in confirming the safety profile of Rotarix™.

The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception. The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum. This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure. Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up. No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied. Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance. The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure. Twenty-eight patients will be enrolled in this study over a period of 36 months. Preoperative assessment will include clinical examination the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP. If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.

This is an epidemiology study designed to implement hospital-based active surveillance for intussusception (IS) in children <1 year of age and lower respiratory tract infection (LRTI)-related deaths among children between 29 days and 1 year of age in Mexico. An existing linked database of the "Instituto Mexicano del Seguro Social (IMSS)" will be used. The study described in this protocol is a pilot study, which will evaluate the methodology to be used in a later Post-Marketing Surveillance (PMS) study. The planned epidemiology study will be conducted in IMSS hospitals and potentially use the IMSS database to re-capture potential cases of IS and fatal cases and as a source of matched case controls. The purpose of this project is to complement this data link system with an active surveillance system for IS - in order to assess the feasibility of using the IMSS data system by generating results that provide scientific validity. Such comprehensive (passive and active) surveillance systems will facilitate the post licensure safety profile evaluation of vaccines such as a vaccine against rotavirus diarrhoea. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.