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Tundra lists 8 Parastomal Hernia clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT06474403
Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
Abstract: Parastomal hernia is a frequent complication following stoma formation, presenting a significant surgical challenge with high recurrence rates. The present study explores the efficacy of the laparoscopic total extraperitoneal (TEP) approach in parastomal hernia repair, conceived as a modification of the Sugabecker's operation. This prospective work, who analysis aims to evaluate the feasibility, safety, and recurrence rates associated with this minimally invasive technique. Methods: A comprehensive review of patients undergoing laparoscopic TEP parastomal hernia repair between 2024 and 2026 will be performed. Patient demographics, operative details, intraoperative complications, postoperative morbidity, recovery times, and hernia recurrence rates will be collate and analyze. Results: The study will include 30 patients with a median follow-up period of 1month (firstly viewer's point) and 12 months (second view point ). The all of parastomal hernias will associated with colostomies. Early mobilization will achieve, with most patients returning to their routine activities within 2 weeks. Discussion: We anticipate that the data will suggest the laparoscopic TEP technique for parastomal hernia repair is a viable alternative to traditional methods, with a favorable safety profile. The minimally invasive nature of the operation appears to facilitate enhanced recovery while maintaining low recurrence rates. Compared to the original Sugarbaker operation, where the mesh is placed intraperitoneally, the extraperitoneal placement of the mesh in TEP repair minimizes the potential for adhesion formation and related complications. Furthermore, aesthetic outcomes and patient satisfaction reports indicate a positive outlook. Conclusion: The laparoscopic TEP approach for parastomal hernia repair offers a modification to the Sugarbaker operation with potential benefits, including reduced operative morbidity, faster recovery, and potentially lower recurrence rates. Extended follow-up and comparison with the traditional approach are warranted to conclusively establish the long-term outcomes of this technique. This study contributes to the evolving surgical management of parastomal hernias, advancing towards less invasive and more patient-centered treatment modalities.
Gender: All
Ages: 18 Years - Any
Updated: 2026-01-21
NCT07056868
A Prospective Randomized Controlled Trial Comparing Extraperitoneal Stoma Creation Via the Arcuate Line Approach Versus Conventional Transperitoneal Stoma Formation for the Prevention of Parastomal Hernia
This study is a prospective, randomized controlled trial designed to compare two surgical techniques for stoma creation in patients undergoing colorectal surgery. The trial evaluates whether an extraperitoneal stoma created via the arcuate line approach can reduce the risk of developing parastomal hernia compared to the conventional transperitoneal stoma formation. Parastomal hernia is a common complication after stoma surgery, often requiring additional treatment or surgery. By testing a novel surgical route that avoids entering the abdominal cavity, this study aims to improve postoperative outcomes and quality of life for patients requiring a permanent stoma.
Gender: All
Ages: 18 Years - 80 Years
Updated: 2025-07-09
NCT06864377
Ventral Hernia Improvement of Treatment and Life
The goal of this clinical trial called the VITAL study is to learn if surgery has a positive impact on the quality of life in patients with incisional or parastomal hernia. The main questions it aims to answer are: Does surgery alleviate patients from their initial problem? Does new discomfort arise after surgery? Do the symptoms worsen, and does quality of life deteriorate in patients who are not offered surgery? The project will also look at time to surgery and postoperative complications. Researchers will send questionnaires to the patients to answer. Participants will: Answer the baseline questionnaire. Answer the follow-up questionnaires at 1 month, 3 months, 6 months, 1 year, and 3 years after surgery or after the baseline questionnaire has been completed for those patients being managed conservatively with observation
Gender: All
Ages: 18 Years - Any
Updated: 2025-03-21
NCT06674187
Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
\*\*Research Background\*\* Colostomy surgery is a common surgical procedure widely used for the treatment of various gastrointestinal diseases, including rectal cancer, ulcerative colitis, and Crohn's disease. Although this surgery can significantly improve patients' quality of life and prognosis, the incidence of postoperative complications, particularly parastomal hernia (PSH), is relatively high. PSH refers to the formation of an abdominal wall hernia around the stoma, with an incidence rate that can reach up to 50%. PSH not only affects patients' quality of life but can also lead to pain, stoma dysfunction, and the need for reoperation, increasing medical costs and patient burden. Therefore, how to effectively prevent PSH has become an important topic in clinical research. \*\*Epidemiology of Parastomal Hernia\*\* The incidence of PSH varies across different studies, ranging from 10% to 50%. This variation may be due to differences in study design, patient characteristics, and surgical techniques. A systematic review and meta-analysis showed that the incidence of PSH differs significantly among different surgical techniques, with higher rates observed in traditional non-molding suturing techniques. Another large cohort study found that the incidence of PSH varies among different age groups and patients with different underlying diseases, suggesting that PSH occurrence may be influenced by multiple factors. \*\*Risk Factors for Parastomal Hernia\*\* 1. \*\*Patient Factors\*\*: * \*\*Advanced Age\*\*: Older patients have reduced tissue elasticity and muscle strength, making them more susceptible to PSH. * \*\*Obesity\*\*: Obese patients have higher intra-abdominal pressure, increasing the risk of PSH. * \*\*Smoking\*\*: Smoking impairs wound healing, increasing the risk of PSH. * \*\*Chronic Obstructive Pulmonary Disease (COPD)\*\*: COPD patients often experience coughing and breathing difficulties, leading to increased intra-abdominal pressure and a higher risk of PSH. * \*\*Diabetes\*\*: Diabetic patients have poorer wound healing capabilities, making them more prone to PSH. * \*\*Malnutrition\*\*: Malnutrition impairs tissue repair, increasing the risk of PSH. 2. \*\*Surgical Factors\*\*: * \*\*Surgical Technique\*\*: Different surgical techniques have a significant impact on the incidence of PSH. Traditional non-molding suturing techniques, which lack support for the tissues around the stoma, have a higher incidence of PSH. * \*\*Stoma Location\*\*: Improper stoma placement, such as outside the rectus abdominis muscle, increases the risk of PSH. * \*\*Stoma Size\*\*: An oversized or undersized stoma can affect stoma function and increase the risk of PSH. * \*\*Use of Mesh\*\*: Using synthetic or biological mesh can significantly reduce the incidence of PSH. However, the use of mesh may bring risks of infection and other complications. 3. \*\*Postoperative Factors\*\*: * \*\*Early Mobilization\*\*: Appropriate early mobilization promotes circulation and wound healing, but excessive activity can increase intra-abdominal pressure and the risk of PSH. * \*\*Increased Intra-abdominal Pressure\*\*: Activities such as coughing, constipation, and heavy lifting can increase intra-abdominal pressure and the risk of PSH. * \*\*Infection\*\*: Postoperative infections can impair wound healing and increase the risk of PSH. \*\*Prevention Strategies for Parastomal Hernia\*\* 1. \*\*Improvement in Surgical Techniques\*\*: * \*\*Mesenteric Molding Suturing\*\*: In recent years, mesenteric molding suturing has gained attention due to its potential advantages. Mesenteric molding suturing strengthens the support around the stoma, reducing the protrusion of abdominal contents and thus lowering the incidence of PSH. A retrospective study showed that patients who underwent mesenteric molding suturing had a significantly lower incidence of PSH compared to those who received traditional non-molding suturing. However, these studies are mostly retrospective and have certain biases and limitations, lacking high-quality prospective randomized controlled trials to validate these findings. * \*\*Use of Mesh\*\*: Some studies have shown that using synthetic or biological mesh can significantly reduce the incidence of PSH. The mesh provides additional support, reducing the protrusion of abdominal contents and thus lowering the risk of PSH. However, the use of mesh may bring risks of infection and other complications, requiring a careful balance of benefits and risks. 2. \*\*Postoperative Care\*\*: * \*\*Early Mobilization Guidance\*\*: Appropriate early mobilization promotes circulation and wound healing, but excessive activity should be avoided to prevent increased intra-abdominal pressure. * \*\*Avoidance of Increased Intra-abdominal Pressure\*\*: Patients should be advised to avoid activities that can increase intra-abdominal pressure, such as coughing, constipation, and heavy lifting. * \*\*Infection Prevention\*\*: Keeping the stoma area clean and dry and promptly managi
Gender: All
Ages: 18 Years - 75 Years
Updated: 2024-11-19
NCT06533839
Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh
Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia. Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes. The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.
Gender: All
Ages: 18 Years - Any
Updated: 2024-08-01
1 state
NCT04282473
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.
Gender: All
Ages: 18 Years - Any
Updated: 2024-06-25
NCT03799939
Chimney Trial of Parastomal Hernia Prevention
Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
Gender: All
Ages: 18 Years - Any
Updated: 2024-02-01
NCT04440514
Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)
Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.
Gender: All
Updated: 2023-03-09