Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
Summary
The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life.
Description
Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hernia. Symptoms associated with parastomal hernias goes from mild physical (pain) and cosmetic discomfort to life threatening conditions with obstruction, strangulation and perforation. Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem.
The surgical treatment of parastomal hernias is controversial. The best way to treat it is to restore the continuity of the intestine, but in permanent stomas, this is not an option. Many surgical techniques have been described when intervention is required, but the results are unacceptable. The traditional open techniques are local simple suturing of the fascia defect, stoma relocation, or repair with a prosthetic material either intraperitoneally or extraperitoneally (subfascial or onlay). Overall, the results of all methods are poor with high recurrence rates and high morbidity and mortality. Mesh repair has the lowest recurrence rate (0-39%) and stoma relocation and simple suture has reported recurrence rates on 0-76% and 46-100%, respectively. Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series. The results so far are encouraging, but the follow-up period is short.
Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall, we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future. Therefore, we find it interesting to investigate the technique in a prospective study
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hernia
Intervention
Laparoscopic parastomal hernia repair with mesh
Status
Withdrawn
Source
University Hospital, Gentofte, Copenhagen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00138957
- 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.
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.
Hernia, Umbilical
A HERNIA due to an imperfect closure or weakness of the umbilical ring. It appears as a skin-covered protrusion at the UMBILICUS during crying, coughing, or straining. The hernia generally consists of OMENTUM or SMALL INTESTINE. The vast majority of umbilical hernias are congenital but can be acquired due to severe abdominal distention.
Clinical Trials
Laparoscopic Intraperitoneal Mesh Repair of Ventral Hernia: Comparison to Conventional Mesh Repair
The laparoscopic repair of ventral hernias is still a controversial therapeutic option. To evaluate the efficacy and safety of laparoscopic repair we compare the results of the open and la...
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.
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...
ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment
This purpose of this study is to compare the recovery after an operation of an incisional hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in the rep...
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-Trial)
1. General - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery 2. Laparoscopic surgery - at least 5 cm o...
PubMed Articles
Mesh erosion following laparoscopic incisional hernia repair.
Laparascopic mesh repair is a safe and effective method of surgically treating incisional hernia. However, such an approach may lead to specific complications of both laparoscopy and mesh placement. T...
Conventional reparation of parastomal hernia.
The reparation of parastomal hernias and their recurrence remain problematic although the implementation of mesh techniques has lowered recurrences rates. Conventional surgical techniques include sutu...
Long-term follow-up of laparoscopic repair of parastomal hernia using a bilayer mesh with a slit.
BACKGROUND: Open surgery for parastomal hernia has been associated with high morbidity and recurrence rates exceeding 50%. Laparoscopic mesh repair is a promising alternative. Published series on lapa...
BACKGROUND: The advent of laparoscopic ventral hernia repair (LVHR) not only reduced the morbidity associated with open repair but also led to a decrease in the hernia recurrence...
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...
