Track topics on Twitter Track topics that are important to you
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Control CT, Clinical Follow Up, Reinforcement with Light Polypropylene Mesh
Not yet recruiting
Hospital Universitari Joan XXIII de Tarragona.
Published on BioPortfolio: 2016-09-12T18:38:21-0400
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene...
Complex ventral hernia is a challenging problem well known to be associated with occurrence of serious complications. The major problems encountered in such cases Include: loss of domain w...
Tension-less mesh repair is the most common procedure for inguinal hernia. Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is ...
For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weig...
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure per...
The type of mesh (synthetic vs. biological) play integral roles in the recovery and long-term outcomes of patients undergoing hernia repair. The aim of this study was to determine whether a biological...
Laparoscopic large para-oesophageal hiatal hernia (LPHH) repair using mesh reinforcement significantly reduces postoperative recurrence rates compared to conventional suture repair, especially within ...
Hernia repair for large and complex hernias presents challenges related to the availability of larger mesh sizes. When sizes beyond those manufactured are required, multiple meshes (MM) may be sutured...
Polypropylene (PP) mesh has been used as a primary or adjuvant material for vaginal reconstruction for both stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for decades. Whether polyp...
Symptomatic paraesophageal hernia (PEH) is an indication for surgical repair. Laparoscopic suture repair has high recurrence rates. Many surgeons prefer mesh repair to reduce PEH recurrence. Several t...
Clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Any woven or knit material of open texture used in surgery for the repair, reconstruction, or substitution of tissue. The mesh is usually a synthetic fabric made of various polymers. It is occasionally made of metal.
Study subjects in COHORT STUDIES whose outcomes are unknown e.g., because they could not or did not wish to attend follow-up visits.(from Dictionary of Epidemiology, 5th ed.)
Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...