View clinical trials related to Parastomal Hernia.
Filter by:The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.
Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.
TITLE: "Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ". DESIGN: Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio. POPULATION: Patients undergoing colorectal cancer surgery a definitive end colostomy. OBJECTIVES: The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery. Secondary objectives are: 1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery. 2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. 4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale). DESCRIPTION OF THE INTERVENTION: An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia. DURATION OF THE STUDY: The expected duration of the study is 3 years. PATIENT FOLLOW UP TIME: The planned follow-up time is 2 years. EXPECTED RECRUITMENT TIME: 12 months.
The intention is to examine the role of ultrasonographic examination inside intestinal stomas in diagnosing parastomal hernia. Patients with a stoma since at least one year back who are being scheduled for abdominal surgery will be examined for eligibility according to the selection criteria. Included patients will undergo routine clinical examination, endostomal ultrasonography and computerized tomography scan of the abdomen. Findings will be correlated to findings during surgery (gold standard). Values for sensitivity, specificity, predictive values and likelihood ratio will be calculated.
This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
The aim of this clinical trial is to investigate the safety and efficacy of prophylactic mesh on prevention of parastomal hernia(PSH) after ileal conduit urinary diversion (IC) in a randomized controlled fashion.
Introduction Parastomal hernia is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider that actually, almost all patients present parastomal hernia in the long-term fallow up (3). Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing since the beginning the weak peristomal area of the abdominal wall. Existing scientific evidence, although positive, is limited and does not allow to clarify some controversial issues as the type of prosthetic mesh to be used and the optimal position of the mesh in relation to the abdominal wall (4-8). The use of laparoscopic approach in colorectal surgery is increasing and also sets technical changes to the placement of the mesh. To date, there are some technical notes (9) and two published prospective, observational studies that include patients underwent laparoscopic surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is used, with encouraging short-term results, but they need more scientific support. Study Design This is a prospective, randomized, single center, clinical study where the sample is represented by patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy. Patients who accept to participate and are suitable for inclusion to the study will be randomized into one of the two branches consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro. Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent parastomal hernia end colostomy versus realization of end colostomy by conventional technique. Primary Objective: Compare the incidence of parastomal hernias between groups during the monitoring period. Secondary objectives: Compare the overall and specific postoperative morbidity and mortality between groups, compare the difference in surgical time between the conventional technique and the prosthetic mesh group, compare hospital stay between the groups.