Preventing incisional hernias at the umbilical trocar site using a special suture-mesh.
Prevention of Incisional Hernia With Mesh-suture (Duramesh Suture) at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach
This study is testing if a special suture-mesh can help prevent incisional hernias at the belly button area after laparoscopic surgery in patients who are at higher risk for this problem.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henares University Hospital Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06251583 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a suture-mesh in preventing incisional hernias at the umbilical trocar site following laparoscopic surgery. It focuses on patients with specific risk factors, such as obesity and other health conditions, who are more likely to develop this complication. The trial compares the outcomes of using suture-mesh against conventional monofilament sutures to determine if it can significantly reduce the incidence of hernias. The study is designed as a Phase 3 interventional trial, indicating a robust approach to assessing the intervention's efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with umbilical trocar incisions larger than 10 mm and specific risk factors for hernia development.
Not a fit: Patients with smaller trocar incisions, existing hernias, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of incisional hernias, leading to better patient outcomes and lower healthcare costs.
How similar studies have performed: While there have been attempts to use prophylactic meshes in similar contexts, this specific approach with suture-mesh is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (at least 18 year-old patients) * Umbilical trocar incision \> 10 mm * Any of the following risk factors: BMI \> 27, Absence of primary umbilical hernia or smaller than 1 cm, active smoking, malnutrition, anemia, oncological surgery, diabetes, heart failure, chronic kidney disease, chronic liver disease, collagen disease, chronic pulmonary disease. Exclusion Criteria: * Umbilical trocar incision \< 10 mm * Umbilical hernia \> 10 mm * Hernia surgery or incisional hernia at the trocar site * Conversion to laparotomy * Pregnancy * Ascites or cirrhosis * Clasification of the American Anestesiology Classification IV o V. * Inadequate follow-up * Patients included in any other trial * Patients with life expectancy \< 12 months * Patients with any kind of sensibility to Duramesh
Where this trial is running
Madrid
- Miguel Ángel García Ureña — Madrid, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.