Gastrostomy

This research aims to evaluate the effectiveness of using a 3D scan to create personalized ostomy appliances for people with an ostomy. The study focuses on whether a 3D scan of the stoma can reduce leakages and improve quality of life compared to standard care. Ostomy appliances collect waste from the stoma but often cause complications such as skin irritation, leaks, and infections, which impact patients' daily lives. Participants will have their stoma scanned with a 3D scanner to create a detailed digital model. This model is then edited and used to produce a personalized ostomy appliance by modifying standard appliances with a laser cutter. The study involves two 2-week periods where participants use their usual ostomy appliance first, then the personalized 3D-printed appliance. The personalized appliances are designed with input from an ostomy nursing team to ensure proper fit based on each patient's body and stoma. During the 4-week study, participants will complete daily symptom diaries and weekly quality of life surveys conducted over the phone. Researchers will track leak incidents, the number of appliances used, and overall patient satisfaction. The study includes ongoing monitoring through electronic surveys requiring internet and device access. Total participation lasts about one month, with safety and quality of life as key measures.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Researchers are evaluating the effects and safety of dexamethasone palmitate compared to traditional dexamethasone for preventing postoperative nausea and vomiting (PONV) after open surgery. Although dexamethasone is commonly used to reduce PONV, some patients still experience symptoms within 24 hours after surgery. Dexamethasone palmitate has a longer-lasting anti-inflammatory effect and fewer side effects, making it a promising option for managing PONV. Participants will be randomly assigned to one of two groups. One group will receive an intravenous injection of dexamethasone palmitate 8 mg (containing 5 mg dexamethasone) after anesthesia induction and before surgical incision. The other group will receive an intravenous injection of dexamethasone 5 mg at the same time. The trial compares these treatments in patients undergoing elective open surgeries such as spinal, chest, or abdominal surgery. During the study, researchers will monitor participants for the incidence and severity of PONV at multiple time points within 72 hours after surgery. They will also track the use of rescue antiemetic medications, participant satisfaction with PONV management, pain levels using the VAS scale, quality of postoperative recovery, length of hospital stay, and safety outcomes up to one month after surgery. The main outcome is the occurrence of PONV within the first 24 hours postoperatively. Participation lasts through the surgery and follow-up periods as described.

Researchers are investigating whether the thickness of gastrostomy tubes affects the rate of postoperative complications in children who need long-term enteral nutrition. This study compares two tube sizes, 12 Fr and 14 Fr, to see if a smaller tube might reduce issues such as granuloma, infection, pain, dislocation, and leakage. Gastrostomy is a common procedure in children with conditions like neurological diseases and metabolic disorders, and the study aims to provide clearer guidance on tube size choice. Children scheduled for laparoscopic gastrostomy are randomly assigned to receive either a 12 Fr or 14 Fr gastrostomy tube. After surgery, the tubes are changed at three months following national guidelines. Both families and healthcare personnel complete questionnaires about any complications experienced during this period. The data collected will be analyzed to determine if tube size influences complication rates. Participants will have a gastrostomy placed and then return for a follow-up visit three months later when the tube is changed. During this visit, questionnaires about complications such as granuloma formation, infection, pain, dislocation, and leakage will be completed by nurses and caregivers. The study will collect and analyze this information to assess outcomes. Participation involves surgery, follow-up care, and data collection over a three-month postoperative period.

Researchers are evaluating the use of an ultrasound-guided external oblique intercostal fascial plane (EOI) block to reduce pain during and after laparoscopic gastrostomy surgery in children ages 3 to 18 years. This randomized controlled trial compares the effects of the EOI block using ropivacaine against a sham block using normal saline to understand its impact on heart rate changes and pain management during surgery. Participants will be randomly assigned to receive either a bilateral EOI block with 0.25% ropivacaine or a sham block with normal saline, both performed under ultrasound guidance. The study measures include the percent change in heart rate at the time of surgical incision as the primary outcome, along with secondary outcomes such as fentanyl use during surgery, various pain scores, analgesia nociception index values, and any analgesia-related side effects. During the study, children's pain levels will be monitored at multiple time points after surgery using standardized pain scales. Researchers will also track the use of pain medications up to 24 hours post-operation and monitor for any adverse effects related to analgesia. The trial is conducted under general anesthesia, and heart rate and blood pressure changes will be recorded around the time of surgery to evaluate the intervention's effectiveness.

Researchers are studying a new type of adjustable skin disk called the Constant Pressure Skin Disk (CPSD) for use with feeding tubes placed in the stomach or small intestine, such as gastrointestinal gastrostomy (GIG) or jejunostomy (GIJ) tubes. The study aims to find out if the CPSD supports proper healing and reduces complications compared to the usual external skin disks. This research is led by Mayo Clinic and involves outpatient adults who need these feeding tubes. During the feeding tube placement procedure, a gastroenterologist or interventional radiologist will replace the standard adjustable skin disk with the CPSD by sliding the original disk off and sliding the CPSD onto the tube. Participants will receive regular care for their tube placement along with the CPSD device. The study focuses on the durability of the CPSD over 180 days and monitors any adverse events during this period. Participants will be followed for six months after placement to assess how well the CPSD holds up and to track any complications. Researchers will evaluate device durability and record any side effects or problems related to the CPSD. The study involves regular assessments during this time to gather safety and performance data, helping to understand if the CPSD could be a better option for patients needing feeding tubes.

Researchers are evaluating the accuracy and reliability of ultrasound Doppler for confirming the correct placement of gastric feeding tubes (GFTs) in intensive care unit (ICU) patients. The study compares ultrasound results to the standard method of chest X-ray (CXR) to see if ultrasound can safely and effectively determine GFT positioning. This research focuses on ICU patients who are intubated and require GFT placement or replacement. Patients will receive a gastric feeding tube, and ultrasound imaging will be performed at both the mid-esophagus and stomach levels using a handheld device. During ultrasound, 20 mL of air will be insufflated through the GFT or a suction catheter in the trachea to look for a specific "mosaic sign" that indicates correct placement in the stomach. These ultrasound images will be anonymized and reviewed by an expert intensivist, then compared to chest X-ray findings. Participants will undergo ultrasound and chest X-ray assessments after GFT placement or replacement. Data collected includes ultrasound images, patient details, ventilator settings, and chest X-ray results. Researchers will monitor safety by recording any adverse events. The main goal is to test how well ultrasound detects proper GFT position. The study is expected to last until August 2025, with ongoing data collection and monitoring during this time.

Obese patients undergoing sedative gastroscopy often face increased risks of hypoxemia due to fat accumulation in the head and neck, increased soft tissue in the oropharynx, reduced lung compliance and volumes, and sometimes obstructive sleep apnea. This research aims to evaluate the safety and optimal flow rate of high-flow nasal cannula oxygen therapy (HFNC) at 30 L/min, 50 L/min, and 70 L/min in obese patients during painless gastroscopy to reduce hypoxia risk without causing discomfort. The study compares three intervention groups where patients receive HFNC oxygen therapy starting with pre-oxygenation at 30 L/min for one minute, then sedation is administered. Oxygen flow is maintained at 30 L/min in one group, increased to 50 L/min in another, and to 70 L/min in the last group after sedation begins. If hypoxemia occurs, behavioral interventions such as jaw lift, increased oxygen flow, mask ventilation, and intubation may be used sequentially to improve oxygenation. Participants will undergo assessments during the procedure focusing on the incidence of hypoxia and related complications such as respiratory depression, airway obstruction, adverse events, paradoxical responses, and airway interventions within six minutes before gastroscopy completion. The study involves monitoring oxygen levels and patient safety throughout the procedure to determine the best HFNC flow rate. The total participation duration corresponds with the gastroscopy procedure and monitoring period.

Researchers are evaluating how stoma care training using the Pecha Kucha presentation method can improve the quality of life and self-sufficiency of individuals living with a stoma. This randomized controlled trial focuses on people who have had a stoma for the first time. The study highlights the increasing number of stoma surgeries due to colorectal cancer and the potential benefits of technology-supported education in patient care. Participants are randomly assigned to one of two groups. The experimental group receives a Pecha Kucha style training via smartphone before hospital discharge, which is a concise, visual presentation lasting about 5 to 7 minutes, also shared through WhatsApp. The control group receives routine stoma care training from a nurse before discharge. Both groups complete quality of life and self-efficacy surveys four weeks after training. During the study, participants provide information through forms and complete online surveys assessing their life quality and self-sufficiency related to stoma care. Researchers measure outcomes four weeks after the training to compare the effects of the Pecha Kucha method versus routine education. Participants may leave the study at any time without penalty. The study is expected to end by September 2025.

This trial is studying an interdisciplinary approach to help children under 3 years old with feeding tubes and tracheostomies transition to oral feeding. The study evaluates whether combining in-home clinical assessments with virtual therapies by a specialized team can improve feeding outcomes. The goal is to increase oral feeding and reduce dependence on feeding tubes while supporting caregivers' confidence and reducing their worry about feeding. Participants are randomly assigned to either an intervention group or a control group. The intervention group receives weekly virtual group mealtime sessions plus biweekly individualized virtual therapies from a team including occupational therapists, speech-language pathologists, registered dietitians, and a developmental behavioral pediatrician. The control group attends weekly virtual group mealtime sessions only. Both groups continue any existing standard care therapies. The study includes initial in-home assessments, ongoing virtual therapy sessions, and a final home visit after one year. Families will participate in enrollment via video conferencing, complete surveys, and take part in scheduled virtual therapy and group sessions over one year. Assessments of feeding, oral intake, caregiver confidence, and dietary history occur at baseline, 3, 6, 9 months, and at the final exit visit after 12 months. Researchers monitor changes in oral calorie intake, feeding frequency, and caregiver self-efficacy. Safety and progress are tracked through regular surveys and home visits during the study period.