The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia. The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
110
All MG patients underwent the procedure with ante rectus positioned prophylactic mesh according to the following standardized technique. A BIO-A circular-shaped mesh measuring 8X10 cm in diameter is prepared with an internal 2 cm hole to let the bowel pass. An at least 8x8 cm space is created between the anterior rectus sheath and the rectus abdominis muscle and, then, the mesh is positioned. The bowel is passed through the rectus muscle via the circular incision in the middle of the mesh. Single absorbable monofilament sutures anchored the mesh laterally in the ante rectus pocket, while medially the mesh is fixed with four stitches to the colon and to both the anterior rectal sheet. The stoma is attached to the skin similarly to CG patients.
Aslnapoli2Nord
Naples, Italy
RECRUITINGfrancesco Pizza
Naples, Italy
NOT_YET_RECRUITINGRate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Time frame: 3 months
Rate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Time frame: 6 months
Rate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Time frame: 12 months
Rate of Parastomal Hernia at clinical control.
Detect of paratoia hernia
Time frame: 24 months
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Time frame: 3 months follow-up
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Time frame: 6 months follow-up
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Time frame: 12 months follow-up
Rate of Parastomal Hernia at tomography observation.
detect of parastomal hernia
Time frame: 24 months follow-up
Number of patients affected by Superficial surgical site infections
Superficial infections according to Clavien-Dindo criteria
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Time frame: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Deep surgical site infections according to Clavien-Dindo criteria
Time frame: Within 30 days postoperatively