The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Md Anderson Cancer Center
Houston, Texas, United States
Number of Participants With Anastomotic Leak.
Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)
Time frame: up to 10 days
Stricture Formation Clinically and by Determination of Dysphagia Score
Patients will be evaluated in the outpatient clinic and will be assigned a dysphagia score from 0-4 by the RSA. Patients reporting symptoms consistent with stricture will be evaluated with radiographic contrast swallow study or endoscopy.
Time frame: 90 days postoperatively
Number of Participants Who Developed Anastomotic Stenosis
If during the follow up period, patients report any symptoms suggestive of anastomotic stricture, a contrast study (esophagram) or endoscopy will be obtained at that time to evaluate for stricture. These tests will be performed as per standard postoperative assessment by the surgeon.
Time frame: 90 days post op
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