Status:
ACTIVE_NOT_RECRUITING
Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Incisional Hernia After Midline Laparotomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective mi...
Eligibility Criteria
Inclusion
- Patients over 18 years of age who will undergo midline laparotomy for oncologic resection of a retroperitoneal tumor or cytoreductive surgery for carcinomatosis of any origin.
Exclusion
- Diagnosed incisional hernia.
- When the planned midline laparotomy is expected to be less than 20 cm.
- Patients with a BMI \> 45 kg/m².
- Patients with abdominal aortic aneurysm.
- Patients with coagulopathy: previously diagnosed with von Willebrand disease, hemophilia, or idiopathic thrombocytopenic purpura.
- Patients with collagen disorders: previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria, or scleroderma.
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07218679
Start Date
May 21 2025
End Date
February 28 2028
Last Update
October 20 2025
Active Locations (1)
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1
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013