Advertisement

Topics

Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation

2014-07-24 14:19:32 | BioPortfolio

Summary

This study is being done to evaluate the use of a material (Alloderm collagen mesh) during the stomal formation operation (surgery that will create a mouth-like opening on the surface of the body to an internal organ) that you have been scheduled for. The main purpose of this research study is to see if using this material will lower the hernia rate compared to normal repair without this material. The secondary purpose is to evaluate if using this material will increase or decrease complication rates.

Description

This study seeks to examine the ability of an implantable collagen matrix to reduce the incidence of parastomal hernia formation. Patients will be randomized preoperatively by a computer generated random allocation to either receive collagen mesh at the time of stoma formation, or to have stoma formation without mesh. Stomas without mesh will be made in the standard surgical fashion dictated by the type of stoma: ileostomy, colostomy, ileal conduit. Patients randomized to receive mesh will undergo stoma formation in an identical fashion, and will have a 8 cm x 12cm piece of AlloDerm mesh placed as a tissue reinforcement at the stoma site and extending under the midline incision. Patients will be followed with physical examinations at approximately 2weeks post-op, 3, 6, 9, 12, 24 months post-op, and will undergo CT scanning of the abdomen and pelvis at 12 and 24months to determine hernia occurrence.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Hernia

Intervention

mesh reinforcement of stoma

Location

Mayo Clinic
Phoenix
Arizona
United States
85054

Status

Recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:32-0400

Clinical Trials [528 Associated Clinical Trials listed on BioPortfolio]

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

Prevention of Hernia After Loop Ileostomy Reversal

PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery are randomized between retro muscular mesh Ultrapro Advanc...

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 ...

Hernia Prevention in Stomas

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 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 [760 Associated PubMed Articles listed on BioPortfolio]

Incidence, risk factors, and prevention of stoma site incisional hernias: a systematic review and meta-analysis.

Stoma reversal might lead to stoma site incisional hernias. Recently, prophylactic mesh reinforcement of the stoma site has gained increased attention, supporting the need for accurate data on stoma s...

Prevention of Parastomal Hernia.

Parastomal hernia (PSH), defined as an incisional hernia at the abdominal wall defect resulting from stoma formation, is a frequent complication of enterostomy (ileostomy and jejunostomy), colostomy, ...

Balancing mesh-related complications and benefits in primary ventral and incisional hernia surgery. A meta-analysis and trial sequential analysis.

Primary ventral hernia (PVH) and incisional hernia (IH) repair using a mesh appears to reduce hernia recurrence. However, are the benefits of mesh offset in part by mesh-related complications? The aim...

Prophylactic mesh used in ileal conduit formation following radical cystectomy: a retrospective cohort.

Given the difficulty of durable repairs, there is continued interest in hernia prevention. One emerging prevention technique for parastomal hernias is prophylactic mesh placement, whereby mesh is inse...

Infection and recurrence rates of the C-QUR V-Patch in ventral hernia repairs.

Ventral hernias are a common surgical issue and a myriad of surgical mesh designs has been developed for their treatment. Many of these new mesh designs have not been extensively tested and their comp...

Medical and Biotech [MESH] Definitions

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.

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.

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.

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.

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.

More From BioPortfolio on "Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Surgical treatments
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...


Searches Linking to this Trial