The primary aim of the study is to determine the efficacy of the placement of an onlay mesh
for prevention of incisional hernia after loop ileostomy closure in patients with a prior
rectal resection for cancer. The efficacy will be evaluated by physical examination 3, 6 and
12 months after surgery and by abdominal CT scan one year after stoma closure.
Secondary aims are to evaluate the tolerability and safety of the prothesis; complications,
quality of life and the need for further treatments will be compared between the groups.
This is a multicentric study that will include patients operated on in hospitals in Catalunya
for loop ileostomy closure after a prior rectal resection for rectal cancer. Elective surgery
for loop ileostomy closure with ASA<4. Exclusion criteria include patients with allergy or
intolerance to polypropilene, with a prior mesh on the abdominal wall, ASA ≥IV, patients with
a life expectancy of <12 months, chronic renal failure in haemodialysis and patients on
steroid therapy.
Patients that agree to participate in the study will be randomized using an electronic
formula (Excel) of a uniformly distributed variable assigning case/control randomly until the
total number of patients are included.
In the control group, after the digestive tract is reconstructed, the closure of the
abdominal wall will be performed with a continuous suture of PDS loop 1/0 following Jenkins
4:1 rule and the skin will be closed using a subcutaneous purse-string closure. Patients in
the study group will have the same procedure performed, and after the aponeurosis closure
with PDS loop, an onlay light polypropilene mesh will be placed.
Each participant will have an assigned code depending on the participating Centre that will
maintain anonymity at all times. All of the information will be registered in a database
specifically designed for the study.
Statistical analysis will be performed by a descriptive study of the demographic variables
and the incidence of incisional hernia after loop ileostomy closure. A comparative study
between the groups will be performed using X2 test for categorical variables and t Student
test or U-Mann for continuous variables. A binary logistic regression will also be performed
to analyse the influence of each variable and to predict if the interventions produce
incisional hernia.