Track topics on Twitter Track topics that are important to you
The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.
A loop ileostomy is a common procedure used to divert fecal matter from anastomotic sites after abdominal surgeries. Major complications from creation and subsequent closure of a temporary loop ileostomy include: stoma retraction, stoma prolapsed, stenosis, herniation, intra-abdominal abscess, anastomotic leak, wound dehiscence. Small-bowel obstruction (SBO) was the most common complication. SBO is caused by adhesions in the surgical site, with narrowing or angulation of the intestine causing obstruction. Prevention of these adhesions may reduce the frequency with which SBO is seen after this surgery. Furthermore, surgery to close the ileostomy is complicated by the presence of adhesions which make dissection of the ileostomy difficult, and increase the risk of injury of the small intestine during dissection, prolonging the operation time in an effort to minimize risk to the patient.
AlloMEM™ is human peritoneal membrane designated by the Food and Drug Administration (FDA) for use as a homologous tissue where native peritoneum is absent or traumatized. The AlloMem™ is not regulated as a device and no 510k submission has been made by the FDA. AlloMem™ is allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft tissue wound covering solely regulated under 361 HCT/P because by FDA definition it is: a) minimally manipulated, b) intended for homologous use only, c) does not involve the combination of cell or other tissues, and d) does not rely on the metabolic function of cells for its primary function. Two animal studies have shown that AlloMEM™ can help prevent intra-abdominal adhesions and provides the biological framework for peritoneal remodeling. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
University Hospitals Case Medical Center
University Hospitals of Cleveland
Published on BioPortfolio: 2014-08-27T03:14:05-0400
Diverting ileostomies are created to protect a rectal anastomosis or in situations with a risk of intestinal perforation. Currently, the application of a rod to hinder slippage of the loop...
This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intest...
We conducted a prospective randomized study to evaluate the results of early closure of temporary loop ileostomy at eight days in comparison with late closure at two months, after elective...
Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy undergoes ...
The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay
A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated ...
The incidence of incisional hernia (IH) at ileostomy closure site has not been sufficiently evaluated. Temporary loop ileostomy is routinely used in patients after low anterior resection for rectal ca...
The incidence of clostridium difficile infection (CDI) has been reported as high as 4% following ileostomy reversal and can be associated with significant morbidity. A systematic review on this subjec...
Individual trials comparing hand-sewn with stapled closure of loop ileostomy show different outcomes due to lack of statistical power. A systematic review, with a pooled analysis of results, might pro...
Ileostomy reversal is associated with surgical site infection (SSI) rates as high as 37%. Recent literature suggests that employing a purse-string approximation (PSA) of the reversal wound reduces thi...
Acute INFLAMMATION in the INTESTINAL MUCOSA of the continent ileal reservoir (or pouch) in patients who have undergone ILEOSTOMY and restorative proctocolectomy (PROCTOCOLECTOMY, RESTORATIVE).
Surgical creation of an external opening into the ILEUM for fecal diversion or drainage. This replacement for the RECTUM is usually created in patients with severe INFLAMMATORY BOWEL DISEASES. Loop (continent) or tube (incontinent) procedures are most often employed.
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...