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

Summary

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.

Conditions

• Gastric Cancer

Interventions

PROCEDURE

Roux-en-Y pouch reconstruction (RYP)

Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).

PROCEDURE

conventional Roux-en-Y reconstruction (RYC)

Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).

Sponsors & Collaborators

• Weill Medical College of Cornell University

  collaborator OTHER

• McMaster University

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Daniel Coit, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2013-08-31

Completion

2013-08-31

Countries

• United States

Study Locations