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
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/-0001 |
| Start Date: | December 2011 |
| End Date: | December 2016 |
| Contact: | Daniel Coit, MD |
| Phone: | 212-639-8411 |
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.
Inclusion Criteria:
- Patient 18 years of age or older
- Pathologically confirmed gastric adenocarcinoma at MSKCC (biopsy may be performed at
other institutions but slides must be confirmed at MSKCC, as is routine care at our
institution)
- No evidence of metastases(a)
- Total gastrectomy performed(b)
- Pouch reconstruction is technically feasible(c)
- Patients will be registered and consent obtained, if the surgeon believes there
is no evidence of metastases. If metastatic disease is identified at the time of
operation, the patient will not be randomized.
- Patients will be conditionally enrolled, and consent obtained, if the surgeon
believes the patient may need a total gastrectomy at the time of operation. If a
total gastrectomy is not performed, the patient will not be randomized.
- Patients will be excluded if, at the time of surgery, the surgeon feels that
creation of a pouch is not technically feasible. This may be due to prior
abdominal surgery, anatomic variants, or anything else at the surgeon's
discretion.
Exclusion Criteria:
- Not expected to be able to provide follow-up over 2 years (due to geographic or other
limitations)
- Not able to complete HRQOL instruments on their own (non-English speaking or physical
status)
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