Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

2014-08-27 03:14:05 | BioPortfolio


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.

Study Design

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
United States




University Hospitals of Cleveland

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:05-0400

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Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus?

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PubMed Articles [19 Associated PubMed Articles listed on BioPortfolio]

Purse-string closure technique reduces the incidence of incisional hernias following the reversal of temporary ileostomy.

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...

Administration of an Oral Hydration Solution Prevents Electrolyte and Fluid Disturbances and Reduces Readmissions in Patients With a Diverting Ileostomy After Colorectal Surgery: a Prospective, Randomized, Controlled Trial.

Patients with a newly formed ileostomy often develop electrolyte abnormalities and dehydration.

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Microscopic ileitis has been infrequently reported in the literature with the few reported cases usually associated with concurrent microscopic colitis. Having encountered a case of collagenous ileiti...

Dietary management in people with an ileostomy: a scoping review protocol.

The objective of this scoping review is to identify and map the evidence for oral dietary management of ileostomies.The primary review question is: what oral dietary strategies for managing ileostomie...

Recurrent gallstone ileus in a patient with ileostomy successfully treated by removal of impacted gallstone via the stoma.

A 75-year-old man with a permanent ileostomy presented with recurrent gallstone ileus that was treated successfully with removal of the stones via the stoma.

Medical and Biotech [MESH] Definitions

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.

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