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Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

NCT02085031 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2014-04-09

No results posted yet for this study

Summary

* To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed.
* To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently.
* However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.

Conditions

  • Stomach Neoplasms
  • Minimally Invasive Surgery
  • Anastomosis

Interventions

PROCEDURE

Intracorporeal Roux-en-Y esophagojejunostomy

During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed.

PROCEDURE

Extracorporeal Roux-en-Y esophagojejunostomy

During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Guoxin Li, M.D., Ph.D. · Nanfang Hospital, Southern Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085031 on ClinicalTrials.gov