Gastric Cancer Clinical Trial
Official title:
A Pilot Randomized Controlled Trial Examining the Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Health-Related Quality of Life in Patients Undergoing Total Gastrectomy for Adenocarcinoma
This study is being done to learn more about how different surgery procedures bring back the
eating pathway after removing the stomach in patients with stomach cancer. If the surgeon
has decided that some, or all, of the patient's stomach must be removed the surgeon must
create a new way to allow food to travel from the mouth to the intestines. Some patients
develop problems because they are missing their stomach, such as lack of hunger, bloating,
cramping, and heartburn.
The surgeons at Memorial Sloan-Kettering Cancer Center are conducting a study to determine
if a change in surgery can help reduce these symptoms.
The most common method of creating a way for food is called a "Roux-en-Y", in which one part
of the intestine is connected with the end of the esophagus (the swallowing tube) in the
abdomen, and another connection is made between the intestines lower down.
The change in surgery involves creating a pouch from a part of the intestines to replace the
stomach.
This study will compare the effects, good and/or bad, of gastric pouch reconstruction with
the usual reconstruction to see if the pouch makes you feel better overall.
This type of surgery has been used by some surgeons for many years and is known to be safe,
but it is not known if it reduces symptoms or improves nutrition compared with the usual
surgery.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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