Clinical Research Directory

Effects of Stoma Education on Patients

tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.

A Single-centre Open, Prospective, Pilot Clinical Study to Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy

This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or colostomy. Eligible patients will undergo surgical implantation of the TIES® Port as part of stoma revision. Participants will be followed for 16 weeks post-implantation to assess device safety, tissue ingrowth and healing, performance, durability, and impact on quality of life. Safety will be evaluated through monitoring of adverse events, while performance and usability will be assessed using structured questionnaires and clinical assessments. Quality of life will be measured using the validated Stoma-QoL questionnaire. The study aims to generate clinical evidence on the feasibility and safety of the TIES® system as an alternative to conventional stoma management.

The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation

The majority of patients (60-70%) develop high levels of anxiety before surgery. Surgical patients may experience feelings of anxiety due to insufficient information and counseling before surgery and potential changes in the body caused by surgery. Fears include (but are not limited to) not waking up from anesthesia, not being able to return to previous work and family life, and adaptation concerns regarding new processes after surgery. Patients with fear of complications experience preoperative anxiety four times more than other patients. Other factors affecting preoperative anxiety were determined to be waiting for a long time before surgery, not knowing what will happen during surgery, losing control of the body, not receiving sufficient social support, being exposed to medical errors, and encountering undesirable health outcomes after surgery. The changes that will occur in the body and lifestyle after stoma surgery scare patients and cause them to feel anxiety in the pre-operative period. Despite significant developments in stoma care products and the increase in the number of nurses specialized in stoma care in recent years, the majority of patients experience problems with compliance. For this reason, the compliance of stoma patients with stoma life is increasingly the subject of clinical trials and epidemiological studies. In our country, studies conducted to determine the problems experienced by stoma individuals regarding compliance with stoma and social life are limited. Nursing interventions are recommended to reduce patients' anxiety and increase their compliance with stoma after surgery. This study aims to evaluate the effect of stoma simulation performed preoperative surgery on the patient's anxiety level and postoperative stoma compliance.

Effect of a Mobile Application on Stoma Adaptation and Quality of Life

This single-blind, parallel-group randomized controlled trial aims to evaluate the effects of a mobile app-based education, counseling, and follow-up program on stoma adaptation and quality of life in adults with a newly ostomy. The study will be conducted at the Stomatherapy Unit of Gazi University Health Research and Application Center (Ankara, Turkey). Participants meeting the inclusion criteria (n=66) will be assigned to intervention (mobile app support + standard care) and control (standard care only) groups in a 1:1 ratio via block randomization; participants will be kept unaware of their group assignment. Participants in the intervention group will download the "Stomatherapy-M" app on the day of discharge and will access structured educational content, receive nurse counseling (messaging and scheduled video calls), and share scheduled follow-up records regularly for six months. Follow-up frequency will be weekly in the first month, biweekly in the second month, and monthly in the following months. Primary outcomes; Adaptation to the stoma (Ostomy Adjustment Inventory) and stoma-related quality of life (Quality of Life Adaptation Scale) assessed at 15 days and 1, 3, and 6 months after discharge. App usability (MAUS) will be measured at 6 months only in the intervention group.

Pediatric Colostomy Reversal: Traditional Care vs. Enhanced Recovery After Surgery

The goal of this clinical trial is to learn whether using an Enhanced Recovery After Surgery (ERAS) protocol helps children recover faster after colostomy reversal compared with traditional care. The main question it aims to answer is: Does ERAS lower the number of days children need to stay in the hospital after colostomy reversal compared with traditional care? Researchers will compare two groups: ERAS group - Children receive shorter pre-surgery fasting, no mechanical bowel preparation, early pain control, and early feeding after surgery. Traditional care group - Children receive the usual long bowel preparation, overnight fasting, opioid pain medicine, and a longer period without food after surgery. Participants will: Be randomly assigned to either the ERAS or traditional care group Have their colostomy surgically closed by experienced pediatric surgeons Be monitored daily until they can eat a solid meal without vomiting; this marks the end of their hospital stay The study will enroll 60 children ages 2-13 at Children's Hospital Faisalabad, Pakistan. Researchers will measure length of hospital stay from surgery until discharge as the main outcome.

Impact on the Absorption of Drugs in Ostomy Patients

Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives. For medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs). The clinical trial´s results will answer the following questions: * Are therapeutic blood levels of psychotropic drugs and NOACs achieved in ostomy patients when taken orally in the usual way? * Are there differences between the measured levels of ileostomy and colostomy patients? Colostomy and ileostomy patients undergoing inpatient or outpatient treatment at the Klinik Ottakring are ready for inclusion. The blood samples will be obtained during medically indicated and performed blood draws within the scope of medical practice, so that no study-associated risks arise here. Recorded and evaluated: * Relevant patient data * Plasma levels of the drugs under investigation in ostomy patients. The therapeutic range specified in the respective approval studies serves as the reference value. The results obtained are documented, evaluated and interpreted in an appropriate manner.

Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal

The goal of this trial is to compare the outcomes of colostomy reversal with three days bowel preparation with no bowel preparation in terms of anastomotic leakage, surgical site infection and hospital stay. The important question this trial aims to answer is: 1\. is there any difference in outcomes after colostomy reversal with three days gut preparation pre-operatively vs no gut preparation? This prospective Randomized Controlled trial will include children with colostomy divided into two groups: Group A: No Mechanical Bowel Preparation Group B: 3 Days Mechanical Bowel Preparation Participants of Group A will be admitted 1 day prior to surgery date as they require no special preparation before surgery. They will be made Nil per oral 6 hours prior to surgery. Group B participants will be admitted 3 days prior to surgery. These participants will be restricted to fiber rich diet and milk 72 hours prior to surgery. They will be shifted to clear liquids 24 hours prior to surgery. Normal saline enema will be given 8 hourly through the stoma as well as per rectally by the trained person. Comparative outcomes will be: 1. Anastomotic leakage 2. Hospital Stay 3. Wound infection

Laparoscopic Hartmann's Reversal Procedure: In the Absence of Standardized Guidelines, we Started a Database of Patient Submitted Reversal Hartman With Standard Technique and Laparoscopic Technique, Prospectively for One Year and a Follow-up Period of 6 Months

Several studies have shown laparoscopic technique's advantages, including more rapid post-operative recovery, less post-operative pain, earlier restoration of bowel function, more rapid return to normal diet, and reduced morbidity but it could still remain a complicated operation due to adhesions and difficulty in identifying the rectal stump. Nevertheless, nowadays laparoscopic technique has largely become part of clinical practice even for younger surgeons. Assumed this, and in the lack of prospective studies, we aimed to confirm the advantages of laparoscopic Hartmann reversal (LHR) by confirming the difference in peri-operative outcomes and postoperative complications. In clinical practice, the first question to be asked is whether there is a right timing for a patient to undergo Hartmann's reversal procedure and whether timing influences the incidence of complications (short-terms and long-terms outcomes). Another aim of the study is to investigate if the length of rectal stump influences the outcome of Hartmann's reversal surgery.

Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication

This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise faecal leakage through the filter compared to colostomy bags with a protective filter