Clinical Research Directory

The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery

The goal of this clinical trial is to explore the difference in 3-year stoma-free survival between the Turnbull-Cutait delayed coloanal anastomosis (TCA) surgery and the low anterior resection combined with protective stoma (LAR) surgery in patients with low rectal cancer, as well as the differences in anal function, surgical complications, and survival outcomes within 1 year after surgery. The main questions it aims to answer are: 1. Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer? 2. Are there differences in postoperative anal function (assessed by LARS score and Wexner score), quality of life (assessed by EORTC QLQ-CR29 questionnaire), surgical complications, pathological outcomes, and long-term survival (disease-free survival, time to recurrence, overall survival) between the two surgical methods? Researchers will compare the TCA group and the LAR group to see if TCA surgery can reduce the permanent stoma rate, improve postoperative anal function and quality of life, and ensure surgical safety and favorable tumor-related outcomes compared with LAR surgery. Participants will: 1. Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio. 2. Receive the corresponding surgical intervention. 3. Complete regular follow-ups at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 after the first surgery. 4. Provide relevant clinical data (perioperative, pathological, follow-up) as required.

Construction and Evaluation of a Flipped Discharge Model for Stomates With Colorectal Cancer

This multicenter randomized controlled trial aims to develop and evaluate the effectiveness of a "Flipped Discharge" intervention for colorectal cancer patients with a new intestinal stoma. Guided by the Response to Transition Theory, the model addresses the care gap during the vulnerable post-discharge period by shifting critical support from the hospital to the patient's home. Approximately 200 eligible patients will be randomized into either the intervention or standard care control group. The core "Flipped Discharge" intervention occurs on the third day post-discharge, delivered either as an in-home visit by a specialist stoma nurse (via an "Internet + Nursing Service" platform) or as an intensive, standardized video follow-up with mailed instructional materials. The study's primary outcome is the incidence of stoma-related complications. Secondary outcomes include quality of life, self-care ability, self-efficacy, stoma adaptation, discharge readiness, healthcare costs, and satisfaction. The trial will also explore the mechanisms by which the intervention affects patient outcomes, ultimately seeking to provide evidence for a feasible, patient-centered model to improve care continuity.

Effect of a Nursing Care Intervention on Outcomes of Stoma Patients Within an Enhanced Recovery Framework

Colorectal cancer is one of the most common cancers in the world and affects a large number of people every year. Surgical intervention and neoadjuvant treatment are mostly preferred for treatment, and temporary or permanent stoma is often opened. Complications that are difficult to manage may arise due to the treatment itself, the disease or the stoma. Complications that are difficult to manage carry a high risk of re-hospitalization. Patients receive limited support during the transition from hospital to home and at home. Patients and their relatives are often alone in home care management until the routine check-up process. Especially patients who are not well prepared for discharge and inadequate in stoma management may not know how to apply care practices during this period at home and the situations they should pay attention to in case of complications. Conditions that can be managed well in the hospital may get out of control when the patient goes home and may cause unplanned re-admissions to the hospital if there is not enough follow-up. Inadequate patient follow-up after surgery may cause patients to be anxious and therefore may cause re-hospitalization due to the inability to manage the home care process in a controlled manner. Although it is known that the duration of hospital stay is shortened with advanced improvement suggestions, different results are remarkable in studies on hospital readmissions, reoperations, developing complications and survival. Since the care needs of patients after surgical intervention vary, there is a need for individualized and evidence-supported suggestions. Currently, advanced improvement suggestions do not include the answer to the question and roadmap of how patients will be followed at home after discharge. The surgical journey should be followed with comprehensive care application steps that are a continuation of evidence-based practices that start from the moment the patient is admitted to the hospital, making them feel that they are not alone during the recovery process they will spend at home after being discharged. The provision of home care management is important for the continuity of the recovery process. Although there are various application models used in the literature for the purpose of preparing and following up on the discharge process, no study has been found that focuses on comprehensive discharge preparation and home care management of stoma patients receiving care in line with advanced recovery recommendations. In this sense, it is believed that the study will be a fundamental study in terms of developing a fourth phase, post-discharge home care management, which is the continuation of the pre-, intra- and post-operative process as included in advanced recovery guidelines and a gap in the literature.

MOBILE EDUCATION AND COMFORT IN OSTOMY PATIENTS

Purpose of the Study This study aims to understand whether a mobile education program can improve comfort levels in people living with a stoma. A stoma is a surgical opening created on the abdomen to allow stool or urine to leave the body. Living with a stoma can affect daily life in many ways, including physical comfort, emotional well-being, social life, and the home environment. The education program used in this study is based on Kolcaba's Comfort Theory. This theory focuses on comfort as a whole and includes physical, emotional, social, and environmental aspects of a person's life. The study will compare people who receive mobile education with those who receive standard hospital care only. Who Can Take Part Adults aged 18 years and older who are scheduled to have colostomy, ileostomy, or urostomy surgery may take part in this study. Participants must be able to communicate in Turkish, read and understand written information, and agree to join the study voluntarily. People with severe cognitive problems, serious communication difficulties, or major vision or hearing problems will not be included. What Will Happen in the Study Participants will be randomly assigned to one of two groups: Mobile Education Group Standard Care Group Both groups will receive routine care provided by the hospital. Participants in the mobile education group will also receive access to a mobile application designed specifically for people with a stoma. This application includes: Easy-to-understand information about stoma care Animated educational videos showing step-by-step stoma care practices Guidance on skin care, pouch changing, and hygiene Information on common problems and when to seek medical help Reminders to support daily stoma care routines The mobile application can be used on smartphones and does not include diagnosis or treatment. It is for education and support only. Participants in the standard care group will receive usual hospital education and care. After the study is completed, they will also be offered the mobile education program. What Participants Will Be Asked to Do All participants will be asked to answer questionnaires that measure comfort levels at several time points: Before surgery One day after surgery Fifteen days after discharge (by phone) One month after surgery (during a clinic visit) Participants in the mobile education group will be shown how to use the application and may use it as often as they wish. Researchers may contact participants to ask about their experience using the app and to identify any difficulties. Possible Benefits Participants may gain better understanding of stoma care and feel more confident managing daily life with a stoma. The mobile education program may help reduce discomfort, support emotional well-being, and improve overall quality of life. The results of this study may help healthcare professionals develop better education tools and support programs for people living with a stoma. Risks and Safety This study does not involve experimental medical treatments. The mobile application provides education only. Personal data will not be collected through the app, and all information will be kept confidential. Participants may leave the study at any time without affecting their medical care. Why This Study Is Important Access to stoma care education can be limited due to time constraints, staff availability, and hospital resources. Mobile education may provide an easy and accessible way for people to receive reliable information whenever they need it. This study will help determine whether a comfort-focused mobile education program can support people living with a stoma and improve their overall comfort and well-being.

The Effect of Escape Room Simulation on Nursing Students' Knowledge and Academic Self-Efficacy Regarding Stoma Care

This research was planned to determine the effect of escape room simulation on nursing students' knowledge and academic self-efficacy levels regarding stoma care. The research was planned as a randomized controlled trial. This research will be conducted with 60 students of the Nursing Department of Başkent University Faculty of Health Sciences between December 29, 2025 and February 28, 2026. All students who agree to participate in the study will be administered the "Descriptive Characteristics Form", the "Stoma Care and Colostomy Irrigation Knowledge Test (pre-test)", and the "Nursing Students Academic Self-Efficacy Scale (pre-test)". Students will be divided into experimental and control groups using a simple randomization method. Students in the experimental group will be given a lecture on stoma care and irrigation by the researcher. After the training, an escape room simulation will be conducted. Each escape room simulation will be conducted with 6 students, in the form of a pre-information session, an escape room simulation application, and an analysis session. In the pre-information session, the simulation objectives, the purpose of the scenario, the roles within the scenario, and the game rules will be explained, and the escape room and standard patient will be briefly introduced to the students in the meeting room. Then, the students will carry out the scenario and game activity (KAHOOT, Table Game, Card Game, Word Cloud, Crossword Puzzle) with a standard patient in the simulation laboratory prepared as an escape room. The researcher will act as a facilitator during the escape room simulation application. During the simulation, if the expected steps are not performed correctly or the game activity is not successfully completed, the team has the right to request hints from the facilitator. Immediately after the escape room simulation is completed, a debriefing session will be held. The debriefing session, lasting approximately 20-30 minutes for each team, will take place in the meeting room located directly opposite the escape room. During the debriefing session, students will be encouraged to express their feelings and thoughts, and feedback will be provided by the researcher. After the debriefing session, and after 1 month the "Stoma Care and Colostomy Irrigation Knowledge Test (post-test)" and the "Nursing Students Academic Self-Efficacy Scale (post-test)" will be administered. All students in the control group will receive instruction on stoma care and irrigation using traditional teaching methods provided by the researcher. After the training is completed, and after 1 month the "Stoma Care and Colostomy Irrigation Knowledge Test (post-test)" and the "Nursing Students Academic Self-Efficacy Scale (post-test)" will be administered. Data analysis will be performed using the IBM SPSS Statistics 26 software package. The main research questions are: Does escape room simulation increases nursing students' knowledge levels regarding stoma care? Does escape room simulation increases nursing students' academic self-efficacy regarding stoma care?

Chinese Ostomy Collaboration Group (COCG) Clinical Study -SITI Classification

Colorectal cancer is an important cancer worldwide, and its incidence is increasing year by year. A large proportion of patients may require diverting stoma or even permanent stoma after surgery. Some of these patients will have a variety of stoma-related complications, which seriously affect the quality of life of patients. At present, the mainstream postoperative complication classification is the traditional CD classification, which is suitable for the classification of most postoperative complications. However, due to the unique anatomical characteristics of patients with stoma, the current CD classification system may not be suitable for the classification of patients with stoma-related complications. Therefore, we plan to establish a registry database of colorectal cancer patients with stoma, explore the attribution and incidence of stoma-related complications, and propose a new improved classification system, the SITI classification, on the existing CD classification, for verification and promotion.