Parastomal Hernia Prevention With Strattice
Summary
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Parastomal Hernia
Intervention
Strattice Reconstructive Matrix, Standard ostomy creation
Location
University of South Alabama
Mobile
Alabama
United States
Status
Active, not recruiting
Source
LifeCell
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00771407
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hernia, Abdominal
A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.
Afferent Loop Syndrome
A complication of gastrojejunostomy (BILLROTH II PROCEDURE), a reconstructive GASTROENTEROSTOMY. It is caused by acute (complete) or chronic (intermittent) obstruction of the afferent jejunal loop due to HERNIA, intussusception, kinking, VOLVULUS, etc. It is characterized by PAIN and VOMITING of BILE-stained fluid.
Hernia, Obturator
A pelvic hernia through the obturator foramen, a large aperture in the hip bone normally covered by a membrane. Obturator hernia can lead to intestinal incarceration and INTESTINAL OBSTRUCTION.
Hernia, Femoral
A groin hernia occurring inferior to the inguinal ligament and medial to the FEMORAL VEIN and FEMORAL ARTERY. The femoral hernia sac has a small neck but may enlarge considerably when it enters the subcutaneous tissue of the thigh. It is caused by defects in the ABDOMINAL WALL.
Hernia, Ventral
A hernia caused by weakness of the anterior ABDOMINAL WALL due to midline defects, previous incisions, or increased intra-abdominal pressure. Ventral hernias include UMBILICAL HERNIA, incisional, epigastric, and spigelian hernias.
Clinical Trials
Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia
The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.
Repair of Infected or Contaminated Hernias
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected...
Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma cre...
Prevention of Parastomal Hernia by Primary Mesh Insertion
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk...
Prevention of Parastomal Hernia With a Mesh
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay pos...
PubMed Articles
Systematic Review of the Use of a Mesh to Prevent Parastomal Hernia.
BACKGROUND: Parastomal hernia is a major complication after stoma placement. Surgical procedures for repairing parastomal hernia are difficult and their failure rate is high. The use of a mesh implant...
Parastomal hernia: clinical and radiological definitions.
INTRODUCTION: Parastomal hernia is a frequent complication after stoma formation. No consistent definition of parastomal hernia has been used in previous studies using clinical examination or computed...
A Novel Technique for the Repair of Urostomal Hernias Using Human Acellular Dermal Matrix.
OBJECTIVE: To report a new technique to reconstruct the abdominal wall at the site of the hernia with 2 separate layers of human acellular dermal matrix (hADM). Parastomal hernia is the most commonly...
Histological appearance of Strattice(TM) tissue matrix used in breast reconstruction.
Laparoscopic modified Sugarbaker technique results in superior recurrence rate.
BACKGROUND: Parastomal hernia (PH) is a frequent complication of stoma formation, occurring in 35-50 % of patients. Recurrence after repair is common, ranging from 24 to 54 % of cases. We hypothesiz...
