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Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure (ILEOMESH)

H

Hospital Universitari Joan XXIII de Tarragona.

Status and phase

Unknown
Phase 4

Conditions

Incisional Hernia

Treatments

Radiation: Control CT
Other: Clinical Follow Up
Procedure: Reinforcement with Light Polypropylene Mesh

Study type

Interventional

Funder types

Other

Identifiers

NCT02896686
ILEOMESH

Details and patient eligibility

About

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

Full 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.

Enrollment

157 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

157 participants in 2 patient groups

Control
Active Comparator group
Description:
Abdominal wall closure will be done by continuous polydioxanone (PDS) suture following a SL:WL ratio of 4:1, and the skin will be closed using a subcutaneous purse-string closure
Treatment:
Radiation: Control CT
Other: Clinical Follow Up
Reinforcement with Mesh
Experimental group
Description:
Abdominal wall closure will be done by continous polydioxanone (PDS) suture following a SL:WL ratio of 4:1. The incision is reinforced with onlay placement of a light polypropylene mesh (3 cm wide and the length corresponding to the incision), fixed to the aponeurosis with interrupted polyglactin (Vycril) suture. The skin will be closed using a subcutaneous purse-string closure
Treatment:
Procedure: Reinforcement with Light Polypropylene Mesh
Radiation: Control CT
Other: Clinical Follow Up

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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