The aim of this clinical trial is to evaluate whether placement of a synthetic prophylactic onlay mesh during definitive fascial closure can reduce the incidence of incisional hernia in adult patients managed with an open abdomen approach following emergency surgery.
The main questions it aims to answer are:
* Does prophylactic mesh placement reduce the incidence of incisional hernia compared with fascial closure without mesh? * Does prophylactic mesh placement influence the occurrence of postoperative complications such as evisceration or surgical site infection?
Researchers will compare patients undergoing definitive fascial closure with prophylactic mesh placement to those undergoing fascial closure without mesh in order to determine whether the mesh decreases the incidence of incisional hernia and associated complications.
Participants will:
* Undergo standard open abdomen management followed by definitive fascial closure. * Be randomly assigned to one of the two study groups:
* Definitive fascial closure without prophylactic mesh. * Definitive fascial closure with placement of a synthetic prophylactic onlay mesh. * Attend clinical follow-up visits in the general surgery outpatient clinic. * Undergo clinical evaluations at 1, 6, and 12 months after surgery, including physical examination and, if necessary, imaging studies to detect incisional hernia or postoperative complications.
Patients older than 18 years.
Patients managed with an open abdomen approach.
Patients undergoing definitive fascial closure.
Patients in whom definitive fascial closure cannot be achieved.
Inability to complete clinical follow-up or high likelihood of loss to follow-up (e.g., residence outside the catchment area, lack of outpatient follow-up, etc.)
Parallel
Definitive Fascial Closure Without Prophylactic Mesh
Procedure/SurgeryPatients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh.
Prophylactic Onlay Mesh Placement
DeviceFollowing definitive fascial closure in patients undergoing open abdomen management, a medium-density, macroporous, non-absorbable synthetic mesh (Optilene®, B. Braun Surgical S.A.) will be placed in the onlay position as prophylactic reinforcement of the abdominal wall. The procedure will be performed during the definitive surgical intervention according to the standard practice of the General Surgery Department.
Incidence of Incisional Hernia
o evaluate the occurrence of incisional hernia following definitive fascial closure in patients undergoing open abdomen management, comparing patients who receive prophylactic onlay mesh reinforcement with those who do not receive prophylactic mesh.
Burst abdomen rate
To evaluate the occurrence of fascial dehiscence (burst abdomen) following definitive fascial closure.
Surgical Site Occurrence
o evaluate the incidence of superficial, deep, or organ/space surgical site complications related to the surgical procedure.
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Hospital San Juan de Dios Tenerife
Lead sponsor
University Hospital of the Nuestra Señora de Candelaria
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
