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

PHASE3CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

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).

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
collaborator

Weill Medical College of Cornell University

OTHER

collaborator

McMaster University

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01491698 - 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 | Biotech Hunter | Biotech Hunter