Clinical trial NCT01113736: Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy
Official title: Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Rectal Cancer
Keywords: Ileostomy
Stenosis
Surgical Wound Dehiscence
Peritoneal
Colorectal Surgery
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Proxy Biomedical Limited
First posted: 2010-04-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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: minimally manipulated; intended for homologous use only; does not involve the combination of cell or other tissues, and 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.

Eligibility criteria: Inclusion Criteria:

* Between 18 - 85 years old at the time of ileostomy formation
* Scheduled to undergo planned diverting loop ileostomy

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients with abdominal or pelvic abscess present at time of initial surgery
* Patients with a history of pulmonary embolism or deep vein thrombosis (DVT) within 1 year of surgery

Primary outcomes:
measure: If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.
timeFrame: Average 1 hour during formation of ileostomy
Secondary outcomes:
measure: Decrease in operative time and a promotion of peritoneal remodeling
timeFrame: During 3 month ileostomy closure
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Conor P. Delaney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jin J, Voskerician G, Hunter SA, McGee MF, Cavazzola LT, Schomisch S, Harth K, Rosen MJ. Human peritoneal membrane controls adhesion formation and host tissue response following intra-abdominal placement in a porcine model. J Surg Res. 2009 Oct;156(2):297-304. doi: 10.1016/j.jss.2009.04.010. Epub 2009 May 13.
citation: Keller DS, Champagne BJ, Stein SL, Ermlich BO, Delaney CP. Pilot study evaluating the efficacy of AlloMEM for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy. Surg Endosc. 2013 Oct;27(10):3891-6. doi: 10.1007/s00464-013-3004-6. Epub 2013 May 14.