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 patients 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 and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

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, childrens 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 interventions 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 Lmin, 50 Lmin, and 70 Lmin 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 Lmin for one minute, then sedation is administered. Oxygen flow is maintained at 30 Lmin in one group, increased to 50 Lmin in another, and to 70 Lmin 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.

Researchers are studying children under 3 years old who have feeding tubes and tracheostomies to test a new intervention aimed at supporting their transition to oral feeding. This study evaluates whether a combined approach using in-home clinical assessments and virtual therapy can help these children increase oral feeding compared to a control group. The intervention involves a coordinated feeding team including occupational therapists, speechlanguage pathologists, dietitians, and a developmental behavioral pediatrician. Participants are divided into two groups an intervention group and a control group. The intervention group receives weekly virtual group mealtime sessions and individual virtual therapy sessions at least every two weeks tailored to their needs. The control group joins weekly virtual group mealtime sessions only. Both groups continue any existing therapies and are assessed regularly. The study includes an initial home enrollment visit, multiple virtual assessments, and a final exit home visit at 1 year. During the study, parents participate in video conferencing for consent and enrollment, complete surveys, and engage in virtual therapy sessions. The team conducts feeding assessments using standardized surveys and dietary histories at enrollment and at 3, 6, 9, and 12 months. Researchers monitor changes in oral calorie intake, feeding frequency, and caregiver confidence. The study lasts one year per participant, with assessments and support provided throughout.