Antireflux Valve Research Articles

3530 ANTI-REFLUX SELF-EXPANDING METAL ESOPHAGEAL STENT: CLINICAL EVALUATION IN PATIENTS.

Introduction: SMES are used for palliation of malignant dysphagia. However, when deployed across the gastroesophageal (GE) junction, they can predispose to GE reflux and related complications. In a previous study on dogs, we showed that the Z-25-18, AR-SMES (Wilson-Cook, NC) was effective in preventing GE reflux. Aim: The aim of this study was to evaluate the clinical efficacy of the AR-SMES in patients with malignant dysphagia. Methods: 11 patients (age 68±12SD) referred for palliation of malignant dysphagia (adenoca 9, sq.ca 1, adeno & sq.ca 1) with involvement of the GEJ were prospectively studied. Two of these patients presented with reflux symptoms after having a different SMES (Ultraflex 1, Wallstent 1) placed across the GEJ. The AR-SMES was placed across the GEJ in all patients using standard techniques. All patients underwent a barium study after stent placement. Pre and post-stent dysphagia score (0- 4), Karnofsky Performance Status (KFS, 8 pts) and symptoms of heartburn and regurgitation (visual analog scale 0-10, 10 severe; 8 pts) were recorded. Patients were followed up at regular intervals. Results: Post stent barium study showed free ante grade flow of barium in all patients. This correlated with significant improvement in dysphagia score (Table). Reflux provocation by head tilting to -30o (done in 7 pts) showed no reflux of barium. Although the anti-reflux valve can invert at high-pressure gradients, the mean daytime heartburn and regurgitation scores were 0.3±0.3 and 0.7±0.4 respectively (Table) and no patient complained of nocturnal symptoms. Median follow up was 8 weeks (range 1 day to 37 weeks). Conclusions: AR-SMES is effective is relieving dysphagia and, as previously shown in animal studies, when deployed across the GEJ, AR-SMES is also effective in preventing GE reflux in humans.

Esofagocardiomioplastia transversal extramucosa mais esofagogastrofundoplicatura parcial no tratamento do megaesôfago

Foram estudados, num período de vinte anos, 215 doentes com megaesôfago, predominando o chagásico, tratados com esofagocardiomioplastia transversal extramucosa mais esofagogastrofundoplicatura parcial, que denominamos técnica de "Girard-Toupet-Lind". Ela foi usada nos pacientes portadores de megaesôfago de graus 2, 3 e 4. Os doentes operados foram 55,6% masculinos e 44,4% femininos. A faixa etria predominante foi entre a idade de 30 e 40 anos. Os autores descrevem pormenorizadamente a sistematização da técnica operatória, salientando sua fcil execução por via abdominal, criando uma ampla passagem na região esofagogástrica através de uma esofagocardiomioplastia transversal extramucosa e a confecção de uma válvula parcial anti-refluxo. Complicações pós-operatórias mediatas e imediatas ocorreram em sete doentes (3,2%), e salientam a baixa morbidez e mortalidade transoperatória nula. Os doentes foram avaliados através de exame clínico, estudos radiográficos, endoscópicos e histopatológicos. Com os resultados clínicos, radiográficos, endoscópicos e histopatológicos, neste estudo, pareceu-nos que a operação realizada trouxe benefícios aos doentes e inclusive aos portadores de megaesôfago grau 4.

SEROUS LINED EXTRAMURAL ILEAL VALVE: A NEW CONTINENT URINARY OUTLET

Purpose We report the functional results following the use of serous lined extramural valve as an antireflux technique and urinary outlet for continent urinary diversion. Materials and Methods The procedure was performed in 18 men and 5 women. The technique entails fashioning 2 serous lined extramural troughs in a detubularized W-shape ileal reservoir. A tapered ileal segment is embedded in 1 trough as an antireflux valve and the ureters are anastomosed to its proximal end. Another tapered ileal segment or the appendix is embedded in the second trough and acts as a continent cutaneous outlet. Results No operative or postoperative mortality was observed. One patient had prolonged ileus which was treated conservatively. All patients were evaluable with a mean followup of 19 months. All patients but 1 were continent day and night. No catheterization difficulties were reported. Evacuation intervals were 4 to 5 hours. Radiographic evaluation demonstrated a continent complaint reservoir, stable and straight outlet, and absence of pouch and ureteral reflux. Conclusions This procedure is technically feasible, surgically versatile, applicable for urinary diversion or conversion and associated with satisfactory outcome.

Wall-incorporated antireflux valve in ileal bladder substitutes: first clinical experience in 17 patients

Objectives. To report on the initial clinical results of a novel technique of a wall-incorporated antireflux valve in ileal urinary reservoirs. Methods. Forty-five centimeters of the terminal ileum were isolated. A double-folded pouch was created using the distal 42 cm, of which the distal 35 cm was detubularized and the proximal 7 cm was left intact to act as a valve. Suturing at the borders of the valve was performed so that the valve formed part of the pouch wall. The technique was carried out in 17 patients. The mean follow-up period was 24 months (range 12 to 44). The patients were evaluated clinically and radiologically. Endoscopic examination was carried out in 3 patients. Results. None of 17 patients showed reflux on ascending cystography. Excretory urography revealed stable or improved upper tracts in 33 renal units. Hydroureteronephrosis was found in one unit because of ureteroileal stenosis that required operative correction. All patients were continent during the day. Night wetting occurred in 2 patients; imipramine hydrochloride therapy resulted in a complete response in 1 patient and partial improvement in the other. Conclusions. The preliminary results of wall-incorporated antireflux valve are encouraging. It is technically simple and easy. It is not time consuming and requires a shorter ileal segment than that required for the intussuscepted valve. Staples are not used. The vascular pedicle is not manipulated. The wall-incorporated valve is suitable for the normal, dilated, or short ureter. Despite limited clinical experience, the valve may provide a reliable technique for reflux prevention in bladder substitutes.

Esophageal Stent with Antireflux Valve for Tumors Involving the Cardia: Work in Progress

To describe an esophageal stent with a polyester mesh cover and an antireflux valve, and to assess its efficacy in the treatment of patients with inoperable tumors of the gastric cardia. Thirteen patients with adenocarcinoma of the cardia, two patients with squamous cell carcinoma, and three patients with recurrent carcinoma of the gastric fundus after surgery were treated by placement of an esophageal stent with an antireflux valve. The spiral Z stent has a porous, polyester mesh cover and an antireflux sleeve made of pliable polyurethane at its lower end. Placement of the stent was successful in all patients, and their dysphagia disappeared or significantly improved. All were able to swallow solid food, and no patient reported significant reflux or "gas bloat" syndrome prior to death or the end of follow-up. Two patients only complained of minor heartburn. Follow-up barium swallow studies showed the absence of significant gastroesophageal reflux in all patients. No stent migration occurred. The esophageal stent with antireflux valve has been effective in the treatment of malignant obstruction of the cardia and allowed good esophageal passage without migration and major gastroesophageal reflux.

A SEROUS LINED ANTIREFLUX VALVE: IN VIVO FLUOROURODYNAMIC EVALUATION OF ANTIREFLUX CONTINENCE MECHANISM

Purpose We evaluate the fluoroscopic and urodynamic performance of a new serosal lined antireflux continence valve (T pouch valve) using an in vivo animal model. Materials and Methods Intestinal reservoirs were constructed using an in vivo pig model. Multiple serosal lined valves of varying diameters and tunnel lengths were evaluated in the acute (immediately after construction) and chronic (4 weeks postoperatively) settings. Video fluorourodynamic evaluations were performed to identify valve leak point pressures and optimal tunnel length-to-luminal diameter ratios. Results Four serosal lined valves tapered to a diameter of 18 and 30F in 1 and 2 cm. tunnels were evaluated. Immediately following construction of the valves no leakage was observed during reservoir filling (maximal pressure 50 cm. water) or external compression maneuvers to simulate a Valsalva maneuver (maximal intra-reservoir pressure 100 cm. water). Identical fluorourodynamic studies performed after a 4-week recuperation demonstrated leakage through the 30F, 1 cm. tunnel valve during reservoir filling (intra-reservoir pressure 19 cm. water). Increasing the tunnel length of the 30F system to 2 cm. (tunnel length-to-luminal diameter ratio 2:1) eliminated all evidence of valve leakage up to a maximal intra-reservoir pressure of 100 cm. water. Conclusions These studies demonstrate the urodynamic characteristics of a new serosal lined valve. This easily constructed mechanism serves as a reliable antireflux (afferent) or continence (efferent) system.

Management of biliary atresia in the liver transplantation era: A 15-year, single-center experience

Background/Purpose: The aim of this study was to address the perioperative aspects of hepatoportoenterostomy (HPE) for biliary atresia (BA), through the study of a 15-year, single-center experience of the management of this disease. Methods: One hundred twenty-seven patients were divided into three groups, depending on the variant of HPE performed: group A (n = 53) underwent HPE with external diversion of the Roux-en-Y anastomosis; group B (n = 54) underwent HPE with a long (35 to 40cm) Roux-en-Y anastomosis, without diversion; and group C (n =20) underwent the same kind of HPE as group B, but with a modified, “super extensive” dissection of the porta hepatitis. Eleven children in group B had an intussusception type antireflux valve in the Roux-en-Y loop. The porta hepatitis of 105 children was histologically classified in type I to III and correlated with rate of postoperative bile flow and age at surgery. Liver transplantation was performed after HPE in 20 patients. Results: Overall, biliary drainage was achieved in 72.5% of the children after HPE and 26.8% of all patients became jaundice free. Porta hepatitis type III was associated with a significantly higher rate of biliary drainage post-HPE then types I and II. There was no difference in the rate of bile drainage, relative number of jaundice-free patients, and mean number of episodes of cholangitis per year among surgical groups A, B, C. In group A, 43.7% of the patients had complications related to the stoma. The actuarial survival of children who underwent HPE followed by liver transplantation was 85%. Conclusions: (1) There is no correlation between type of porta hepatis and age at surgery for BA; (2) type III porta hepatis is associated with higher rates of bile drainage post-HPE; (3) children older than 16 weeks with BA should still be considered for HPE; (4) in these older patients, factors other than the type of porta hepatis, possibly the degree of liver damage, play a role in the lower rate of bile drainage observed; (5) external diversion of the Roux-en-Y in HPE is not beneficial and is detrimental because of stoma-related complications; (6) an antireflux valve in the Roux-en-Y loop does not reduce the incidence of cholangitis post-HPE; (7) Surgical reexploration does not restore biliary drainage; and (8) sequential therapy with HPE followed by liver transplantation remains the treatment of choice for BA.

Experimental and clinical experience with new pyeloureteral stents in pediatric urology.

In light of the many problems with the use of conventional external stents in supravesical reconstructive urinary tract surgery in children; e.g. the risk of infection, urodynamic malfunction, and lack of flexibility insertion methods, the return to internal pyeloureteral stenting is a much discussed topic in pediatric urology. In order to improve the generally unsatisfactory situation, we developed, together with the Rüsch Co., a new type of directable and deconnectable ureteral stent. This polyurethane catheter features a membrane valve made of soft Wiruthan at the bladder end, which closes automatically with increasing bladder pressure. Thus, urinary backflow from the urinary bladder into the renal pelvis is prevented. Experimental data from antireflux stenting justify the clinical use of such a stent in children, as the urodynamic in vivo criteria and requirements were fulfilled completely. We now have clinical experience with the application of 340 pyeloureteral DD stents in 241 children from 1993 through 1996; 259 stents were inserted intraoperatively, and 81 stents were applied by endoscope. It was impressive that secondarily, renal function that had been considerably reduced could be regained and stabilized by long-term stenting, even in some older children with chronic supravesical ureteral obstruction. Although small technical details have to be clarified, such as simplification of stent retrieval and an antireflux valve that can be applied using an anterograde approach, the DD valve stent used in this patient population after reconstruction of a malformed supravesical urinary tract can be recommended without any reservations.

Further experience with the antireflux valve to prevent ascending cholangitis in biliary atresia

Background/Purpose: The intussusception-type antireflux valve is a mechanism introduced by Nakajo, who reported the results of his initial 17 cases in 1990. This report summarizes our further experience with new patients, together with follow-up results of the cases previously reported by Nakajo. Methods: In total, 46 new patients who had biliary atresia underwent portoenterostomy at the authors' two units. The authors hoped to construct the intussuscepted antireflux valve in the Roux-en-Y loop, whenever possible, at the time of hepatic portoenterostomy. Results: Among the 46 patients, one case each was found to be too young or too old to have the valve constructed during the surgery. In another case, the Roux-en-Y loop became too short after repeated revisions of the portoenterostomy. In another patient, the valve was first constructed but later removed because of jejunal perforation near the valve. In the last patient, the valve was not constructed for unspecified reasons. The authors constructed the antireflux valve in 42 patients, but it was maintained in 41. In one case, the valve truly prevented reflux of the intestinal juice during an episode of intestinal obstruction. The valve was found to be incompetent in one patient 5 years after the initial surgery. Conclusion: The incidence of cholangitis was high in patients with postoperative cystic dilatation of the intrahepatic bile ducts, and low in those without it.

USE OF THE GENIE™ LOW-PROFILE CONVERSION KIT AFTER PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT IN CHILDREN

Percutaneous endoscopic gastrostomy (PEG) has become the preferred method of gastrostomy tube placement in children for nutritional support. Conversion of the PEG tube to a low profile level device is often deferred for 6-12 weeks after PEG placement to avoid disruption of the PEG tract. The Genie™ (Bard, Billerica, MA) provides a method of conversion to a low profile device without removal of the original PEG tube. The tube is clamped at skin level, cut, then a plug with an antireflux valve and retention clip are attached to the tube. This allows flexibility with regard to timing of conversion as it can be performed at the time of original PEG placement or delayed if so required. The purpose of this retrospective study was to assess the technique and complication rate of conversion to the Genie™ low profile device after PEG tube placement in children. Eight subjects, 4-18 years of age, weight 10-60 kg, had Genie™ low profile devices placed at Morristown Memorial Hospital between May 1996 and June 1997. Underlying diagnoses were spastic quadriplegia (4), cystic fibrosis (2), Rett syndrome (1), and Dandy-Walker malformation (1). Using general anesthesia and peri-operative antibiotics, #20 French Ponsky™ PEG tubes were placed by the “push” technique (over a guidewire). The tube was converted to the low profile device immediately in 3 subjects. In the other 5 patients, conversion was performed 2 days to 4 months later. Length of follow-up after conversion ranged from 1 week to 1 year. No significant complications were noted during conversion or in follow-up. One patient developed incompetence of the antireflux valve 3 months after conversion, treated by traction removal of the device and replacement with a different low profile device. There were no episodes of internal bolster migration into the tract or separation of components of the low profile device. Conclusion: The Genie™ low profile conversion kit can be used in children and has the advantage of early conversion to a low profile device. Use of the device avoids the discomfort and cost of a second procedure. There were no major complications noted from conversion to the low profile device. Longer follow up is necessary to determine the durability of the device over time.

Simple antireflux valve in ileal bladder substitutes: An experimental study in dogs

Objectives To provide a simple, reliable and easy antireflux valve in ileal bladder substitutes. Methods Forty centimeters of the terminal ileum were isolated. A double-folded pouch was formed using the distal 37 cm, of which the proximal 7 cm were left intact to act as a valve. The remaining distal 30 cm were detubularized. Suturing at the borders of the valve was performed through linear seromuscular grooves created by diathermy burn. The ureters were anastomosed end-to-side to the supravalvular segment. The pouch was anastomosed to the trigone after subtotal cystectomy. The technique was carried out in 10 female mongrel dogs. All dogs were evaluated by ascending cystography and excretory urography at 12 and 20 weeks. Autopsy and histopathologic examination of the valve were carried out after the animals were killed at 20 weeks. Results None of the 10 animals showed ureteral reflux in ascending cystography. Excretory urography revealed a perfect upper tract except in a dog that showed bilateral hydroureteronephrosis due to bilateral ureteroileal stenosis. Conclusions This new valve is technically simple and easy. The procedure is not time consuming and staples are not required. The vascular pedicle is not manipulated. A shorter ileal segment is used in this type of valve construction in comparison with that required for the intussuscepted valve. This valve appears to be reliable for reflux prevention in ileal bladder substitutes.

Complications of the Afferent Antireflux Valve Mechanism in the Kock Ileal Reservoir

Purpose Since 1982 the Kock ileal reservoir has been the primary form of urinary diversion in patients requiring lower urinary tract reconstruction at our institution. The intussuscepted afferent nipple valve of the Kock ileal reservoir is designed to prevent reflux and protect the upper urinary tract. Problems associated specifically with the afferent antireflux valve have been few. We defined and characterized all complications associated with the Kock pouch antireflux nipple valve. Materials and Methods From November 1984 through July 1992, 802 patients underwent construction of a continent Kock ileal reservoir. All complications associated with the afferent antireflux valve in this group and their management were identified. Results Overall, 79 of 802 patients (9.8 percent) had a total of 84 complications of the afferent antireflux valve (10.4 percent), including formation of stones on staples securing the afferent nipple valve in 42 cases (5.2 percent), stenosis of the afferent valve in 35 (4.3 percent) and prolapse of the valve in 7 (0.9 percent). A total of 81 patients required surgical intervention to correct the afferent valve complication: 56 (7.0 percent) were treated endoscopically and 25 (3.1 percent) required open surgical revision. Conclusions We report an overall complication rate of 10.4 percent associated with the afferent antireflux nipple valve in the Kock ileal reservoir. Most complications can be treated endoscopically without difficulty on an outpatient basis with the use of local sedation. With these results, and only a 3 percent incidence of open surgical correction of all afferent nipple problems, we encourage the continued use of the intussuscepted afferent nipple valve whenever continent urinary diversion is performed.

Complications of the Afferent Antireflux Valve Mechanism in the Kock Ileal Reservoir

Complications of the Afferent Antireflux Valve Mechanism in the Kock Ileal Reservoir

The intussusception antireflux valve is ineffective in preventing cholangitis in biliary atresia

Cholangitis is the most common complication after portoenterostomy for biliary atresia. The construction of an intussusception valve in the Roux-en-Y limb of the portoenterostomy has been advocated as a means to ameliorate this complication. The authors reviewed the records of children who underwent portoenterostomy to assess the incidence and severity of cholangitis, as well as outcome. The children were divided into two groups according to whether they did not have (group I) or did have (group II) an antireflux valve in the Roux limb of the bilioenteric conduit. There were 19 children in each group. There were no significant differences between the groups with respect to age at time of portoenterostomy or length of follow-up (Table 1). Nine group I patients are alive and well; five died and five have had or are awaiting transplantation. In group II, 10 patients are alive and well, eight have had transplantation, and one is awaiting transplantation. Outcome with respect to death or the need for liver transplantation because of progressive hepatic failure is not different between the groups ( P = 1.0, Fisher's 2 × 2). The incidence of cholangitis was evaluated by comparing the average number of episodes of cholangitis during the follow-up period, the number of episodes per year, and the number of episodes in the first postoperative year (when this complication is most prevalent). Analysis of the data showed no difference in incidence between those with valved and nonvalved biliary conduits. The severity of cholangitis, judged by total length of antibiotic treatment, did not differ between the groups. It appears that the presence of an intussusception valve in the Roux-en-Y biliary conduit does not affect the incidence of cholangitis or the outcome after portoenterostomy, over short-term follow-up.

Report of three gastric tumors in children

The literature concerning gastric tumors in children is mainly limited to case studies. The authors reviewed 1,403 histological reports of pediatric gastric pathology (covering 10 years) at their institution. There were three gastric tumors of benign histology and no malignant tumors. The first patient was a 9 1 2 - year-old boy who presented with several months of symptomatic, pH-probe-confirmed gastroesophageal reflux. He underwent placement of a Toupet antireflux valve. During laparotomy, a submucosal mass was discovered incidentally, on the greater curvature of the stomach. The mass was excised. Pathological examination showed heterotopic pancreas. The second patient, a 15-month-old girl, presented with a short period of vomiting. Results of an upper gastrointestinal series showed gastric outlet obstruction. She underwent laparotomy and was found to have an intussusception of a gastric polyp into the proximal jejunum, and an associated malrotation. Ladd's procedure, gastroduoduodenostomy with reduction of the intussuscepted polyp, and excision of the polyp were performed. Histological examination of the tumor showed hamartoma with hyperplastic elements. The tumor was benign but was regarded as difficult to classify. The third patient, a 6-year-old boy, presented with microcytic anemia. Endoscopy showed multiple friable bleeding gastric masses. He underwent laparotomy, with partial gastrectomy and pyloroplasty. Histological examination showed the tumor to be plasma cell granuloma. The tumor recurred, and the patient required subsequent operative procedures. The authors confirm that gastric tumors in children are rare. Although the tumor histology may be benign, excision of the tumor may require major operative resection.

Clinical experience of lower urinary tract reconstruction using a urethral Kock pouch.

The operative procedure used in the present series involved a nerve-sparing radical cystectomy, with anastomosis of the urethra using a pouch made of detubularized ileum. The 36 patients who underwent this operation were all male with an average age of 58. No deaths resulted from the operation. As far as late complications were concerned, malfunction of the antireflux nipple valve was noted in 1 patient and stenosis occurred between the urethra and pouch in 2. One patient was found to have multiple stones in the pouch and reservoir decompensation was recognized in 2. Thus, the late complication rate was 17%. There were no cases of total incontinence, but nocturnal incontinence appeared in 11 out of 31 (35%). A total of 20 out of 25 patients (80%) recovered their erectile function during the postoperative follow-up period and the disease-free survival rate at 5 years was 78%. Therefore, the urethral Kock pouch combined with nerve-sparing cystectomy has proved to be a useful procedure as far as the quality of life is concerned.

Stenosis of the Afferent Antireflux Valve in the Kock Pouch Continent Urinary Diversion: Diagnosis and Management

Between August 1982 and May 1988, 503 patients underwent construction of a continent ileal reservoir (Kock pouch) for cutaneous urinary diversion at our university. Stenosis of the afferent antireflux valve resulted in upper urinary tract obstruction in 11 patients (2%). In addition, 2 patients underwent Kock pouch diversion elsewhere and upon referral to our institution they had afferent valve stenosis. To date 13 patients have been identified with this problem.Hydronephrosis was present in 100% of the functional kidneys in these patients. Radiographs of the Kock pouch were uniformly normal without evidence of reflux or other pathological condition. The most common presenting symptom was flank pain in 7 patients (54%) and the most common presenting sign was creatinine elevation above baseline in 7 (54%). Infections recurred with or without sepsis in 5 patients (38%). Ureteroileal anastomotic strictures were not present in any patient. The interval from creation of the Kock pouch to the diagnosis of stenosis ranged from 2 to 75 months (mean 39).All patients underwent endoscopic evaluation of the Kock pouch confirming stenosis of the afferent antireflux valve, and subsequent mechanical dilation of the stenotic valve. Dilation procedures were repeated in 6 patients (46%), 4 of whom subsequently required open surgical revision of the afferent valve. Of these patients 3 are clinically stable and 1 died of the primary malignancy. The remaining 2 patients are clinically and radiographically stable after multiple dilations. Of the 7 patients (54%) requiring only a single dilation 6 are clinically stable and 1 died of the primary malignancy.Stenosis of the afferent antireflux valve of the Kock pouch, previously unreported to our knowledge, is a rare late complication leading to flank pain, hydronephrosis, recurrent infection and elevation of serum creatinine levels. Approximately 50% of the patients respond to a single dilation of the nipple valve. However, most patients who require repeat dilation will need open surgical revision.

Derivazione ortotopica continente tipo emiKock: Nostra esperienza

Between May 1991 and October 1993, 16 male patients with bladder neoplasms underwent surgical hemiKock's technique of continent urinary reservoir: 7 patients were staged T1, 4 patients were T2, 3 patients were T3 and 2 patients were T4. 5 patients underwent neo-adjuvant M-VAC chemotherapy before surgery, 2 patients underwent radiotherapy and 2 patients underwent adjuvant chemotherapy after surgery. Demolition of the bladder, prostate and seminal vesicles was made by both an ascending and descending manoeuvre, and was sectioned just below the veru montanum to spare the external urinary sphincter. In 7 patients we followed Walsh's technique to spare neurovascular bundles. 60 to 62 cm of small intestine was selected for reservoir construction, stopping 20-30 cm before the ileo-cecal valve. Particular care was adopted for construction of the antireflux nipple valve; uretero-ileal anastomosis was made following Wallace's technique. Mean term of surgery was 6 hours. Sovrapubic cystostomy was removed after 8 days, and urethral catheter after 21 days. After a mean follow up of 3-30 months our results are the following: 2 patients deceased for a pelvic relapse and general metastasis. In one patient we had a neoplastic relapse just on the ileo-urethral anastomosis, so permanent catheterism was necessary.

Nosocomial catheter-associated bacteriuria: a clinical trial comparing two closed urinary drainage systems

We compared the time of onset and incidence of nosocomial bacteriuria between two different closed urinary drainage systems: a simple closed drainage system containing an antireflux valve (‘Urias A-4’) and a complex closed drainage system (‘Curity Infection Control System’) incorporating: (1) a preconnected, coated catheter, (2) a tamper discouraging seal at the catheter-drainage tubing junction, (3) a drip chamber, (4) an antireflux valve, (5) a hydrophobic drainage bag vent and (6) a povidone—iodine releasing cartridge in line with the outlet tube of the urine collection bag. 181 non-bacteriuric patients, requiring catheter drainage for more than 48 h, were assigned by chance to either of the two systems. Bacteriological monitoring of bladder urines of the enrolled patients was performed every 24 h by establishing viable counts and identification of all microorganisms. No differences in the onset and incidence of nosocomial bacteriuria between the two urine drainage system groups were noted. We conclude that additional complex features aimed at preventing intraluminal spread of bacteria did not reduce the risk of urinary tract infection, compared to a simple closed urinary drainage system.

Retrograde (ascending) bacterial contamination of enteral diet administration systems.

A prospective clinical study in three phases was performed to determine whether it was possible that enteral diet containers could become contaminated as a result of endogenous organisms ascending retrogradely from the enteral feeding tube via the giving set, and if this did occur whether the incidence could be altered by modifying enteral delivery systems. Each phase observed patients on enteral feeding over a 48-hour study period (phase I, n = 18; phase II, n = 17; phase III, n = 18). Each patient was prescribed an enteral diet of 2 L/24 h administered by continuous pump infusion from a closed 1-L sterile diet container. Four containers were used for each patient, and one giving set was used in the 48-hour period. Diet samples were taken at 12-hour intervals: two from the giving set before and after flushing with residual diet, and one from the diet container. Phases differed only in the design of the giving set: phase I had no drip chamber, phase II had a drip chamber, phase III had a drip chamber and an anti-reflux ball valve at the distal end. Both phase I and III had greater numbers of giving set samples colonized at 24, 36, and 48 hours. In phase I, 3 of 14 sterile diet containers were colonized with greater than 10(4) colony-forming organisms/mL of diet at 48 hours. Only phase II had no organisms contaminating the containers at 48 hours. We conclude that the retrograde spread of organisms from patient to sterile diet container does occur in clinical practice, and that a drip chamber in the giving set may prevent the problem.(ABSTRACT TRUNCATED AT 250 WORDS)