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Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

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

Summary

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.

Description

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

Conditions

Ileostomy

Intervention

AlloMEM™

Location

University Hospitals Case Medical Center
Cleveland
Ohio
United States
44106

Status

Recruiting

Source

University Hospitals of Cleveland

Results (where available)

View Results

Links

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

Clinical Trials [62 Associated Clinical Trials listed on BioPortfolio]

Diverting Loop Ileostomy: With or Without Rod

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...

Osmolality of Oral Supplements and Ileostomy Output

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...

Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy

This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feas...

Early Temporary Stoma Closure After Proctectomy

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...

Does Bowel Stimulation Before Loop Ileostomy Closure Reduce Postoperative Ileus?

Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have previously demonstrated that the defunctionalized bowel of a loop ileostomy undergoes ...

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...

Hand-Sewn versus Stapled Closure of Loop Ileostomy: A Meta-Analysis.

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...

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.

Microscopic ileitis in diverted and non-diverted enteric segments: an under-recognized condition with a multifactorial etiology.

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...

Use of an ACE inhibitor or angiotensin receptor blocker is a major risk factor for dehydration requiring readmission in the setting of a new ileostomy.

Diverting ileostomies help prevent major complications related to anastomoses after colorectal resection but can cause metabolic derangement and hypovolemia, leading to readmission. This paper aims to...

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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