Colostomy

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 studying the use of a stoma self-care app accessed through the LINE official account, a communication platform popular among Chinese users, to help patients with enterostomy. The study aims to explore how technology acceptance and task technology fit impact patients' self-care ability and quality of life. Enterostomy patients often face challenges in self-care that can lead to complications, affecting their physical and emotional well-being as well as their families. The study compares two groups: one using the stoma self-care app as an intervention and a control group receiving traditional education with a health manual and oral instructions. This is a randomized, single-blind, quasi-experimental study involving patients after colostomy surgery. The intervention starts on the first day after surgery and integrates models to assess and improve self-care knowledge, ability, and quality of life. Participants will be evaluated using scales for enterostomy self-care knowledge, self-care ability, and quality of life from day 1 to day 28 after surgery. Questionnaires will assess task technology fit and usage behavior. The study monitors how well patients adapt to stoma care and measures their quality of life during this period to understand the impact of the app compared to conventional education.

Researchers are evaluating colostomy bags with an active chamber filter system to see if they reduce filter-related problems such as ballooning, pancaking, odor, and fecal leakage compared to bags with a protective filter. The study focuses on adults living with a colostomy who experience these complications frequently. It is designed as a three-way crossover study, allowing each participant to try different types of colostomy bags. Participants will use three types of colostomy bags—Confidence Be 1-Piece Closed Bag with an active chamber filter (circle shape), Confidence Natural 1-Piece Closed Bag with a protective filter (circle shape), and Confidence Be go 1-Piece Closed Bag with an active chamber filter (hexagon shape). Each bag will be used for a 7-day period or up to 21 closed bags, with participants changing bags as they normally would or when necessary. The study lasts 21 days in total, divided into three 7-day test periods. During the study, participants will report on filter-related complications such as ballooning, pancaking, odor, and fecal leakage through the filter. Researchers will monitor the incidence and timing of these issues over the 21-day period. Participants will complete questionnaires in English about their experiences, and their independent colostomy care will be supported throughout. The study aims to measure the effectiveness of the active chamber filter system in reducing common colostomy bag problems.

Researchers are conducting an observational study to explore if proteomics, metabolomics, and proteoglycans can predict postoperative complications and serve as biomarkers for colorectal cancer. The study focuses on whether these biomarkers can detect anastomotic leakages, predict cancer recurrence, act as diagnostic tests, and be identified in tumor tissue. Participants include patients undergoing elective colorectal surgery or stoma closure, including those with colorectal cancer or benign colorectal diseases. Participants will undergo elective colorectal resections or colostomy reversals using either open or minimally invasive techniques. Blood samples will be collected daily from postoperative day 1 to day 4 or until discharge, with additional follow-up sampling at specific intervals up to three years for those diagnosed with cancer. Tumor biopsies will be taken from surgical specimens during the operation to analyze proteoglycans and other markers. Throughout the study, researchers will collect data from blood plasma and tissue to identify biomarkers predicting postoperative complications and cancer outcomes. Medical records will be reviewed prospectively for complications and mortality up to 90 days, and cancer recurrence will be tracked for up to four years. The study aims to correlate biomarker levels in plasma with tumor tissue and evaluate their diagnostic and monitoring potential for colorectal cancer.

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.

This observational study focuses on parastomal hernia repair using endoscopic methods. It evaluates laparoscopic and robotic extraperitoneal mesh repair techniques that include transversus abdominis release (TAR) and mesh reinforcement following the Sugarbaker principle. The study aims to assess these surgical approaches and their outcomes over time. The repair involves an endoscopic trans-abdominal preperitoneal plasty (TAPP) method placing mesh extraabdominally, anterior to the transversalis fascia. Both laparoscopic and robotic procedures are used, with additional repair of any midline hernias through an enhanced-view Rives-Stoppa technique. This approach is studied for safety and effectiveness in reinforcing hernia repair. Participants will be monitored for adverse events within one month after the procedure, with further follow-up over two years to observe late complications and hernia recurrence. The study collects data through clinical evaluations during this period. Participation duration varies with follow-up assessments scheduled up to two years after surgery to ensure comprehensive monitoring of outcomes.

Researchers are evaluating the use of a novel Single Port (SP) Robotic Platform for colorectal surgery procedures. This study compares the safety and quality of colorectal surgeries performed with the SP platform against those done using the traditional Multi-port (Xi) robotic system. The goal is to assess whether the SP technology can be used effectively and safely for both transabdominal and transanal colorectal operations. Participants will undergo colorectal surgery using the Intuitive Da Vinci Single Port SP system, with surgical procedures determined by standard clinical care. The study tracks perioperative outcomes to compare them with cases performed using the Multi-port Xi system. This is an open-label, non-randomized study conducted at a single center, focusing on feasibility and quality of the SP platform. During the study, researchers will monitor clinical parameters including safety and quality events within 30 days after surgery. Participants must provide informed consent and comply with study requirements, including follow-up assessments. The study aims to gather detailed data to evaluate the surgical outcomes and safety profile of the SP robotic technology in colorectal surgery over the course of the trial.

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.

Parastomal hernia is a common complication following stoma surgery that poses significant challenges due to high recurrence rates and impacts patient quality of life. This research investigates a laparoscopic total extraperitoneal (TEP) technique as a modification of the traditional Sugabecker's operation. The study aims to assess the feasibility, safety, and recurrence rates of this minimally invasive approach compared to standard methods. The study involves two groups of patients with parastomal hernias: one receiving the traditional Sugarbaker procedure with intraperitoneal onlay mesh (IPOM) placement, and the other undergoing the modified laparoscopic TEP repair where mesh is placed entirely in the extraperitoneal space. The laparoscopic TEP method includes a unilateral transrectal incision and creation of a preperitoneal or retro-rectus space to position the mesh. This approach is expected to reduce operative trauma and complications compared to the open method. Participants will be monitored for intraoperative complications, postoperative pain, infectious complications, length of hospital stay, and hernia recurrence over a follow-up period of up to one year. Quality of life will be assessed using the SF-36 survey at multiple time points. Early mobilization and recovery will be encouraged, with routine activities expected to resume within two weeks. The primary outcome is the hernia recurrence rate at one year post-operation, along with secondary measures including infection rates, pain levels, hospital stay length, and quality of life improvements.