Clinical trial NCT02896686: Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure
Official title: Multicentric, Prospective, Randomized and Simple Blind Study 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Incisional Hernia
Keywords: Ileostomy closure
Polypropylene Mesh
Incisional hernia
Lead sponsor: Hospital Universitari Joan XXIII de Tarragona.
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* ASA (American Society of Anesthesiologists)\<4

Exclusion Criteria:

* allergy or intolerance to polypropilene
* patients with a prior mesh on the abdominal wall
* ASA ≥IV
* patients with a life expectancy of \<12 months
* chronic renal failure in haemodialysis
* patients on steroid therapy

Primary outcomes:
measure: Incidence of incisional hernia
timeFrame: 12 months
Secondary outcomes:
measure: Perioperative complications
timeFrame: 30 days
measure: Quality of life of the patients
timeFrame: 3, 6 and 12 months after surgery
Other outcomes:
Locations:
Study officials:
References: