A precision-designed gastrostomy button securement device.

BACKGROUND: Gastrostomy buttons (g-buttons) are commonly placed in children to facilitate weight gain, correct nutritional deficiencies, and provide hydration and/or medication delivery. At our institution, parents are taught to place a gauze sponge under their child's g-button and secure it with strips of tape; however, the g-button still moves in the tract, which delays wound healing and leads to a variety of tract-related complications. We viewed this universal problem as a challenge and a prime opportunity for innovation. METHODS: In 2016, a pediatric surgeon and a team of graduate engineering students outlined the problem, created a list of design requirements, and began to iterate on a variety of device designs. RESULTS: Over 400 design ideas were iterated upon to various degrees. The first prototype was studied in a small clinical trial, in which 80% of caregivers reported satisfaction with the design, but 90% noted difficulty connecting the extension feeding tube. A second-generation prototype was developed, which included a reusable lid and disposable base layer. Third- generation prototypes added "edge-grippers" to facilitate attaching the extension tubing, plus pre-cut absorbent, sterile gauze pads to fit around the stem of the g-button. Finally, in 2020, the design was finalized with the addition of a childproof hinge between the lid and base layer. CONCLUSIONS: An intuitive g-button securement device was created to simplify daily gauze replacement, reduce tract-related complications, and lower the cost of care. A randomized controlled trial comparing the securement device to the "tic-tac-toe" dressing will begin in early 2022 with results available later this year.

Management of Postoperative Complications Following Common Pediatric Operations.

This review discusses complications unique to pediatric surgical populations. Here the authors focus primarily on five of the most common procedures performed in children: appendectomy, central venous catheterization, pyloromyotomy, gastrostomy, and inguinal/umbilical hernia repair.

Buried bumper syndrome: prevention and management in the community.

Percutaneous endoscopic gastrostomy (PEG) is a well-established form of artificial nutrition. Buried bumper syndrome (BBS) is a rare but severe complication related to this type of feeding tube. BBS is described as when the internal bumper migrates into the stoma tract and/or the mucosa, and the inner lining of the stomach starts to grow around and over the internal bumper. It can result in pain, infection and the loss of the feeding tube as a port of entry for delivery of nutrition, hydration and medication into the stomach. When suspected, BBS requires urgent referral into specialist hospital services. It is somewhat preventable with appropriate aftercare; however, incidents do occur. The evidence and guidance on care of PEGs differs, and more data and research are needed into the incidence of BBS and what influences it. Access to appropriate nutrition support teams is essential to support patients and their caregivers with all aspects of enteral feeding.

Radiology guided antegrade GASTROSTOMY deployment of mushroom (pull type) catheters with classical and modified methods in patients with oropharyngeal, laryngeal carcinoma, and anesthesia risk.

OBJECTIVE: The aim of study is to evaluate the results of deployment of Percutaneous Radiological Gastrostomy (PRG), which is a good alternative to Surgical Gastrostomy (SG), with transoral approach in cases where Percutaneous Endoscopic Gastrostomy (PEG) is contraindicated, difficult or unsuccessful, in patients with high risk of American Society of Anesthesiologists with four scores. In addition, we aimed to demonstrate the advantages of mushroom pull type catheters over push type gastrostomy catheters. METHODS: This retrospective study included a total of 40 patients (18 females and 22 males) aged 21-92 years who underwent PRG with the antegrade transoral approach. PRG was performed by retrograde passing through the esophagus or snaring the guidewire from the stomach and taking out of the anterior abdominal wall. Patients' demographic data, indications for PRG, procedural outcomes and complications were screened and recorded. RESULTS: PRG was performed in 39 of 40 patients included in the study. Technical success rate was 97.5%. Procedure-dependent major complications such as death, aspiration, colon perforation, and deep abscess were not observed. Aspiration occurred in the first patient during the first feeding on the day after the procedure. Major complication rate was 2.5%. The total minor complication rate was 17.5% in 7 patients; parastomal leakage in 2 patients (5%), skin rash and infection in 3 (7.5%) patients, minor bleeding in 2 (5%) patients with oropharynx cancer, minimal bleeding from the gastrostomy catheter 1 week after the procedure in 1 (2.5%) patient. None of the cases had buried buffer. Tube functionality was preserved in all patients without any damage. CONCLUSION: Mushroom tip (pull type) gastrostomy catheter is a safe treatment method for patients requiring prolonged feeding because of wide diameter, endurance, long staying opening duration, less excessive dilatation and parastomal leakage, and no need for gastropexy. Lower cost and easier access are advantageous for mushroom tip pull type catheters compared to push type gastrostomy catheters in our country. The less invasive PRG is an alternative option in patients who are difficult to administer PEG, are at high anesthesia risk and cannot be sedated. ADVANCES IN KNOWLEDGE: This article is valuable in terms of its contribution to develop an alternative radiological method for the deployment of gastrostomy tubes in medical difficult patients. This method has shortened the duration of the procedure and increased the success rate in patients with difficulty in transition from the stomach to the esophagus or with difficulty in the upper gastrointestinal tract. Mushroom tip catheters can be placed successfully by radiological methods.

Gastrocutaneous fistulas after PEG removal in adult cancer patients: frequency and treatment options.

INTRODUCTION AND AIMS: PEG removal in head and neck cancer patients (HNCPs) is performed after treatment, in case of disease remission and after adequate oral intake is resumed. The PEG tract usually closes spontaneously within 2-3 days. Persistent gastrocutaneous fistula (GCF) is a rare complication after PEG tube removal and is characterized by the persistence of gastric leakage through the fistulous tract for more than 1 month. Our main goal was to access the incidence and the success of a treatment algorithm for GCF in HNCPs. METHODS: Retrospective unicentric study of HNCPs referred for PEG removal between 2014 and 2018. The patients with GCF were selected and their sequential treatment was reviewed. RESULTS: In 331 patients with PEGs removed, 19 (5.7%) GCFs were documented. Medical therapy (4-8 weeks) was performed with clinical success (definitive closure of the GCF) in 12 (63.2%) patients. The remaining seven patients required endoscopic or surgical treatment. In four, endoscopic treatment had technical and clinical success (in three patients with fulguration of the gastric leak edges with argon plasma coagulation, silver nitrate in the path and external orifice, and closure of the internal orifice with hemoclips and in one with an over-the-scope-clip). Only three patients underwent surgery, one due to clinical failure of sequential endoscopic therapy and two had direct surgery. CONCLUSION: GCF occurs rarely after PEG removal in HNCPs. Medical therapy is usually effective and should be maintained for at least 8 weeks. Endoscopic therapy is an effective second-line option with and surgery rarely required.

Surgical Gastrostomy in Pediatric Patients Undergoing Cardiac Surgery.

BACKGROUND: Practices of performing gastrostomy tubes vary across institutions for patients undergoing cardiac surgery. We aim to elucidate the outcomes of gastrostomy and the duration of feeding assistance in these patients. MATERIALS AND METHODS: Patients undergoing cardiac surgery (CS) at our institution from 2013 to 2017 were retrospectively reviewed using the Society of Thoracic Surgery database. A cohort of non-CS patients undergoing gastrostomy tube (g-tube) placement from 2013 to 2015 was used as control. Technical complications and postoperative feeding intolerance were analyzed. Duration of need for g-tube was also analyzed in patients undergoing CS. RESULTS: The CS group had 144 patients, and the non-CS group had 677 patients. CS patients had a higher incidence of feeding intolerance (18.8% versus 5.6%, P < 0.001) and took longer to attain full feeds (median of 2 versus 1 d, P < 0.001), and this was confirmed on propensity matched analysis. In addition, technical g-tube complications were similar in the two groups. No mortality in CS was attributed to the g-tube. 58% of patients undergoing CS were able to wean from g-tube feeding by 6-12 mo after g-tube placement. CONCLUSIONS: G-tube placement in patients undergoing CS by any technique is safe without increased complications. A significant portion of these patients was able to wean off supplemental enteral feeding assistance by a year after g-tube placement.

Cerebral and Renal Oxygenation in Infants Undergoing Laparoscopic Gastrostomy Tube Placement.

AIM: The aim of this study was to evaluate the effects of a carbon dioxide pneumoperitoneum on cerebral and renal oxygenation and oxygen extraction, in a cohort of infants from the neonatal intensive care unit, undergoing laparoscopic gastrostomy. METHODS: After institutional review board approval, between February 2018 and June 2019, infants 0-3 mo corrected age, undergoing laparoscopic gastrostomy tube placement, were included. Strict exclusion criteria created a homogeneous cohort. Cerebral and renal tissue oxygen saturation (rSO2) by near-infrared spectroscopy, skin surface oxygen saturation (SpO2), by pulse oximetry, and amplitude-integrated electroencephalography were measured. Monitoring was divided into preoperative, intraoperative and postoperative time periods. Cerebral and renal fractional tissue oxygen extraction was calculated using arterial (SpO2) and tissue oxygen saturation (rSO2): (SpO2-rSO2SpO2)X100. Data were averaged into one-minute epochs and significant changes from baseline during the intraoperative and postoperative periods were detected using one-way analysis of variance with repeated measures. RESULTS: This pilot study examined sixteen infants, born at a median gestational age of 34.2 wk (range: 23.0-40.6) with a median corrected age of 42.9 wk (range: 40.0-46.3) at operation. None had seizure activity or altered sleep-wake cycles. No statistically significant variations in cerebral and renal tissue oxygenation and extraction were observed. Pulse oximetry did demonstrate significant variation from baseline on analysis of variance, but post hoc analysis did not identify any one specific time point at which this difference was significant. CONCLUSIONS: During a short infant laparoscopic procedure, no significant alteration in cerebral or renal oxygenation or oxygen extraction was observed. No seizure activity or changes in infant sleep-wake cycles occurred.

Percutaneous radiologically guided gastrostomy tubes: Procedural description and biomechanical comparison in a canine model.

OBJECTIVE: To describe the novel placement of percutaneous radiologically guided gastrostomy (PRG) tubes in a canine cadaveric model and to biomechanically compare PRG and percutaneous endoscopic gastrostomy (PEG) tube constructs. STUDY DESIGN: Descriptive and biomechanical experimental study. ANIMALS: Fifteen large breed (>25 kg) canine cadavers. METHODS: Percutaneous endoscopic gastrostomy tubes, low-profile PRG tubes, and standard PRG tubes were each placed in five canine cadavers. Body wall and stomach (with attached gastrostomy tube constructs) were harvested and biomechanically tested. Data regarding the maximal load to failure and procedure time were statistically analyzed. RESULTS: Percutaneous endoscopic gastrostomy and PRG tube placement was successful in all cadavers with no procedure-related complications. Gastrostomy tube placement time was longer for the PEG group vs the low-profile PRG (P = .005) and standard PRG (P = .037) groups. Peak construct strength was lower for the PEG group vs the low-profile PRG (P = .002) and standard PRG (P = .010) groups. The site of failure varied among groups. CONCLUSION: Percutaneous radiologically guided gastrostomy tubes were successfully placed in all cases with shorter placement time and greater peak construct strength compared with PEG tubes. CLINICAL SIGNIFICANCE: Due to the increased load to failure as well as decreased placement time recorded for PRG tubes relative to PEG tubes, PRG tubes may be considered as an alternative minimally invasive gastrostomy option in large breed canine patients. Further evaluation in clinical animals is required. Results of this work were presented at the 2019 American College of Veterinary Surgeons Surgery Summit; October 16-19, 2019; Las Vegas, Nevada.

Early Buried Bumper Syndrome Treated by Bedside Replacement

BACKGROUND: Buried bumper syndrome (BBS) mostly occurs as a late complication after percutaneous endoscopic gastrostomy (PEG) insertion; however, early BBS has been rarely reported, and the treatment of this condition is still unclear. OBJECTIVES: To evaluate the Seldinger technique for treatment of early BBS after PEG insertion. METHODS: We report two cases of early BBS in two consecutive patients who underwent PEG insertion to maintain oral intake. The first patient was an 83-year-old woman showing Alzheimer type dementia, while the other one was a 76-year-old man who presented with maxillary cancer and treated with radiotherapy followed by left maxillectomy. Post-surgery, he developed progressive difficulty of swallowing due to mouth deformation and treatment related nerve toxicity. The first patient presented with fever and purulent discharge from the gastrostomy insertion site, without ability to rotate or slide the tube through the stoma 10 days after the PEG insertion. The man was admitted to the hospital 5 days following PEG insertion due to a fever of 38°C and peritubal swelling with purulent discharge. In addition, the tube could not rotate or slide through the stoma. RESULTS: Buried bumper syndrome was demonstrated by computed tomography scan. Gastroscopy and gastrostomy tube replacement was performed successfully according to the Seldinger technique (replacement over guidewire) in both cases. Correct intragastric tube positioning was demonstrated radiographically before resuming tube feeding. The two patients were discharged in good physical condition several days later. CONCLUSIONS: External replacement over guide wire should be considered in such cases.

The Use of a Fixation Dressing to Reduce Complications After Neonatal Gastrostomy Tube Placement.

Objective: Gastrostomy tubes (GTs) are one of the most common procedures in neonatal surgery, and their malfunction represents one of the most common complaints in the emergency room and clinic. Complications can occur in up to one-third of patients and include pain, peristomal leak, and infection, but can range in severity. We hypothesize that a preventative strategy employing a GT fixation dressing at the time of operation minimizes these postoperative complications in neonates. Approach: All patients less than 1 year of age who underwent laparoscopic GT placement by a single surgeon in the study period were reviewed. All tubes were secured in place on the external abdominal wall for 2 weeks postoperatively. Demographics and outcomes were evaluated. Results: Fifty-three percent of our cohort were male, and 47% were premature. The most common indication for placement was failure to thrive (59%), and common comorbid conditions were characterized as neurologic (71%), and cardiac (59%). The dressing did not prevent hypertrophic granulation tissue formation, but no patient experienced surgical site infection or device-related pressure injury at 30 and 120 days postoperatively. No patient required reoperation or readmission. Innovation: This simple, one-time, cost-effective fixation dressing has the potential to reduce some of the most common postoperative surgical issues in neonatal patients and can be applied in almost any health care setting. Conclusions: A dressing aimed at tube fixation and immobilization for the first two postoperative weeks averts some of the major complications of GT placement over a standard follow-up period as compared with the literature.

Conservative recovery and replacement of a ruptured percutaneous endoscopic gastrostomy tube; a case report.

BACKGROUND: Percutaneous Endoscopic Gastrostomy (PEG) feeding tubes are frequently placed in patients to provide enteral nutrition. We report a case of a complete rupture of a PEG tube intra-abdominally with associated peritonitis after more than a month of PEG placement and utilization. To our knowledge, this is a very rare case of a complete PEG rupture with the succeeding replacement and recovery of the fractured segments conservatively. CASE PRESENTATION: A 69-year-old female with a PEG in position and in use for more than a month started complaining of severe abdominal pain. Digital subtraction angiography (DSA) tubogram revealed rupture and separation of the PEG tube into two fragments. Interventional radiology (IR) team was successful with their conservative approach. Both fragments were removed conservatively without the need for laparotomy. The distal fragment was utilized to place a guide wire, and a new PEG was placed in position with no intraabdominal leak. CONCLUSION: Ruptured PEG tube should be considered in the differential of patients complaining of sudden abdominal pain, especially after chronic PEG utilization. Conservative approach by IR is a viable option in correcting this mishap.

Percutaneous endoscopic gastrostomy: dealing with the issue of dislodgement.

Introduction: Percutaneous Endoscopic Gastrostomy (PEG) is accepted as an efficient method to provide long-term enteral nutrition. PEG accidental dislodgement (device exteriorization confirmed by expert evaluation) rate is high and can lead to major morbidity.Objective: To identify independent risk factors for PEG accidental dislodgement.Methods: Retrospective, single-center study, including consecutive patients submitted to PEG procedure, for 38 consecutive months. Every patient had 12 months minimum follow-up after PEG placement. Univariate analysis selected variables with at least marginal association (p < .15) with the outcome variable, PEG dislodgement, which were included in a logistic regression multivariate model. Discriminative power was assessed using area under curve (AUC) of the receiver operating curve (ROC).Results: We included 164 patients, 67.7% (111) were female, mean age was 81 years. We report 59 (36%) PEG dislodgements, of which 13 (7.9%) corresponded to early dislodgements. The variables with marginal association were hypoalbuminemia (p = .095); living at home (p = .049); living in a nursing home (p = .074); cerebrovascular disease (CVD) (p = .028); weight change of more than 5 kg, either increase or decrease (p = .001); psychomotor agitation (p < .001); distance inner bumper-abdominal wall (p = .034) and irregular appointment follow-up (p = .149). At logistic multivariate regression, the significant variables after model adjustment were CVD OR 4.8 (CI 95% 2.0-11.8), weight change OR 4.7 (CI 95%1.6-13.9) and psychomotor agitation OR 18.5 (CI 95% 5.2-65.6), with excellent discriminative power (AUC ROC 0.797 [CI95% 0.719-0.875]).Conclusion: PEG is a common procedure and accidental dislodgement is a frequent complication. CVD, psychomotor agitation and weight change >5 kg increase the risk of this complication and should be seriously considered when establishing patients' individual care requirements.

Aspiration Therapy.

Aspiration therapy is a novel, endoscopic bariatric therapy that allows patients to remove a portion of an ingested meal through a modified percutaneous gastrostomy tube, called an A-Tube. Weight loss results from both fewer calories consumed, and from modifications in lifestyle and mealtime behaviors that patients make as a result of having the device installed. The first commercially available device for aspiration therapy, the AspireAssist (Aspire Bariatrics, King of Prussia, PA), was approved by the Food and Drug Administration in 2016 for weight loss for greater than 6 months duration in patients with a body mass index of 35-55. Multiple studies have demonstrated the effectiveness and safety of aspiration therapy, with low rates of adverse events related to the procedure, including no reported deaths, as well as no evidence of eating disorders developed during therapy. This chapter will describe our experience with aspiration therapy. We will describe how we select appropriate candidates for aspiration therapy, how we perform the procedure including a summary of the equipment used, and how we mitigate and manage complications of the procedure. This article will highlight the effectiveness of aspiration therapy as a novel and safe approach for weight loss in patients in obesity.

A comparison of balloon and nonballoon gastrostomy tubes in children.

PURPOSE: The purpose of this study was to compare primary outcomes following insertion of balloon and nonballoon gastrostomy tubes (G-tubes). METHODS: A retrospective chart review over a 5-year period comparing the need for emergency, radiologic, or operative interventions between balloon and nonballoon G-tube devices was performed. RESULTS: 145 patient charts were reviewed (46.8% female, 53.1% male). The indication for G-tube insertion was failure to thrive in 83.4%. Average age at insertion was 4.3 years (0-17.9 years). 37.2% had a balloon type G-tube, and 62.8% had a nonballoon type. Patients with a nonballoon device had 1.14 (0-15) ER visits related to the G-tube vs. 0.48 (0-6) visits with a balloon device. Of the ER visits for patients with a nonballoon device, 26.9% were replaced in ER, 38.5% in radiology, and 34.6% required an operation for replacement. For patients with a balloon device, 47.8% were replaced in the ER, 52.2% were replaced in radiology (GJ), and none required operative replacement. The majority of patients who initially had a nonballoon G-tube placed required a second operation for device change (95.7%). Patients with nonballoon devices required significantly more operations (average 2.55, range 0-16) vs patients with balloon devices (average 0.40, range 0-3) (p < .05). CONCLUSIONS: Balloon-type G-tubes require less ER visits and operative interventions compared to nonballoon G-tubes. LEVEL OF EVIDENCE: C.

Further Development of Magnetic Compression for Gastrojejunostomy in Rabbits.

BACKGROUND: Technical improvement of gastrojejunostomy is critical in bariatric and metabolic surgery. In this study, a novel magnetic compression approach for gastrojejunostomy was evaluated. MATERIALS AND METHODS: Both cylindrical and rectangular magnets were used in rabbits, and the magnets were named according to their location. All the magnets were perorally introduced into the stomach. The position of the jejunal magnet was controlled by a connecting line. When the jejunal magnet spontaneously entered the jejunum, the gastric magnet was introduced into the stomach. An extracorporeal magnet was used to guide these two magnets together, and the magnet pair was left to create a side-to-side anastomosis. The state of the animals and extrusion time of the magnets were observed. The anastomoses were evaluated by burst pressure and histology. RESULTS: Gastrojejunostomy was successfully established in all animals. Cylindrical and rectangular magnets spontaneously entered the jejunum through the pylorus within 2.4 ± 0.5 and 6.0 ± 0.8 d, respectively (P < 0.01). The cylindrical and rectangular magnet pairs fell off within 15.3 ± 0.8 and 11.9 ± 1.1 d, respectively (P < 0.01). The burst pressures were statistically similar between the two types of magnets (P > 0.05). Histological examination showed sealed anastomoses with mild inflammation of the mucosa and fibrosis within the submucosa. CONCLUSIONS: The feasibility and efficacy of establishing gastrojejunostomy by guidewire introduction of magnets, which were guided together with an extracorporeal magnet, were confirmed in rabbits. In humans, with the clinical use of this procedure, surgery would be greatly simplified.

Initial clinical experience of a steerable access device for EUS-guided biliary drainage.

BACKGROUND AND AIMS: EUS-guided biliary drainage (EUS-BD) has been used as a rescue procedure after failed endoscopic retrograde cholangiography (ERC), and there is growing interest in EUS-BD as a primary therapy for distal malignant biliary obstruction. After EUS-guided needle puncture of an obstructed bile duct, directional control of wire advancement remains an area of need, potentially addressed by a new steerable EUS access system. The aim of this study was to evaluate the safety and efficacy of this novel steerable access system in patients undergoing EUS-BD after failed ERC. METHODS: We performed a retrospective study of prospectively acquired data at 3 tertiary academic hospitals. Consecutive patients who had failed ERC followed by EUS-BD using the access device were included. Primary outcomes were safety and technical feasibility (successful completion of EUS-BD). Secondary outcomes were clinical success (75% improvement in liver function tests at 30 days) and device performance. RESULTS: Twenty-two consecutive patients underwent EUS-BD between October 10, 2018 and March 3, 2019. Needle puncture and selective wire advancement in the intended direction were both successful in 100% of cases (22/22). Technical success was 95% (21/22). Fifty-nine percent (13) underwent rendezvous, 32% (7) underwent choledochoduodenostomy, and 4.5% (1) underwent hepaticogastrostomy. One patient (4.5%) underwent percutaneous transhepatic cholangiography. There were no cases of wire shearing. The adverse event rate was 4.5% (mild pancreatitis in 1 patient). There was no bile leak, bleeding, or death at 30 days' follow-up. CONCLUSIONS: This first clinical experience with a steerable access system for EUS-BD suggests it is safe and effective, particularly with regard to controlling direction of wire advancement.