Prevention of Parastomal Hernia by Mesh Placement
Status: | Terminated |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 6/29/2017 |
Start Date: | August 2015 |
End Date: | March 2017 |
A Randomized Study of the Utility of Composite Mesh Placement to Prevent Parastomal Hernia in Patients Undergoing Urinary Diversion With Ileal Conduit
Total cystectomy (surgical removal of the bladder) is performed in a number of settings,
including invasive bladder cancer and radiation cystitis. This requires a urinary diversion
to be performed. The most common type of urinary diversion in this setting is an ileal
conduit, where a section of small intestine is fashioned into a conduit that drains urine
through a stoma into a pouch appliance, which is adhered at the level of the abdominal wall
skin.
There are multiple risk factors associated with the development of parastomal hernia after
ileal conduit formation, including obesity, stoma site and size of the abdominal wall stoma
opening.
Up to 30% of patients with parastomal hernia will undergo surgical correction, mainly due to
discomfort, urine leakage, skin excoriation, difficulty in maintaining a watertight ostomy
appliance, increased frequency of ostomy pouch changes, or rarely due to bowel
strangulation. Parastomal hernia repair is a challenging procedure which is not without
significant risks. Furthermore, the outcomes of parastomal hernia repair surgery are highly
variable.
Prevention of parastomal hernia resulting from ileal conduit formation will help to decrease
the incidence of hernia related complications, including pain, bowel complications, and
urinary leakage due to poor stoma appliance. It will also decrease the significant cost
associated with frequent stoma pouch changes. Prevention of parastomal hernia is expected to
improve the quality of life of patients undergoing ileal conduit, and will reduce the need
for secondary operations.
including invasive bladder cancer and radiation cystitis. This requires a urinary diversion
to be performed. The most common type of urinary diversion in this setting is an ileal
conduit, where a section of small intestine is fashioned into a conduit that drains urine
through a stoma into a pouch appliance, which is adhered at the level of the abdominal wall
skin.
There are multiple risk factors associated with the development of parastomal hernia after
ileal conduit formation, including obesity, stoma site and size of the abdominal wall stoma
opening.
Up to 30% of patients with parastomal hernia will undergo surgical correction, mainly due to
discomfort, urine leakage, skin excoriation, difficulty in maintaining a watertight ostomy
appliance, increased frequency of ostomy pouch changes, or rarely due to bowel
strangulation. Parastomal hernia repair is a challenging procedure which is not without
significant risks. Furthermore, the outcomes of parastomal hernia repair surgery are highly
variable.
Prevention of parastomal hernia resulting from ileal conduit formation will help to decrease
the incidence of hernia related complications, including pain, bowel complications, and
urinary leakage due to poor stoma appliance. It will also decrease the significant cost
associated with frequent stoma pouch changes. Prevention of parastomal hernia is expected to
improve the quality of life of patients undergoing ileal conduit, and will reduce the need
for secondary operations.
Inclusion Criteria:
1. Patients eligible to undergo urinary diversion with ileal conduit.
2. Patients with the ability to understand and willingness to sign a written informed
consent document.
3. Men and Women aged 18 to 80 years.
Exclusion Criteria:
1. Patients unable or unwilling to consent to the proposed surgery
2. Pregnant women
3. Patients with prior ileal conduit surgery undergoing revision.
We found this trial at
1
site
1400 NW 12th Ave
Miami, Florida 33136
Miami, Florida 33136
(305) 689-5511

Phone: 305-243-7207
University of Miami Hospital The University of Miami changed the face of modern health care...
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