NCT02763878

Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 832 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis.

Detailed description

Gastric cancer is still one of the most common malignant tumors, and gastric antrum cancer is still common. Radical surgery is the only way to treat gastric antrum cancer, surgical procedures and reconstruction are closely related with the prognosis and quality of life, the choice is crucial. Gastrojejunostomy after distal gastrectomy may affect the quality of radical surgery, and postoperative diet, nutritional status and quality of life. More and more centers tend to choose Billroth II anastomosis, but patients prone to have a variety of complications, including reflux gastritis and bile reflux, malnutrition, seriously affecting the quality of life and so on. According to preliminary pilot study found that, uncut Roux-en-Y anastomosis way can keep the continuity of nerve-muscle function of the reconstruction of digestive tract, and closes the input in order to reduce the incidence of reflux, for improving the nutritional status and reducing complications and improve quality of life. Therefore, the investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis.

Conditions

• Nutrition Disorders
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Uncut Roux-en-Y anastomosis	Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis.
PROCEDURE	Billroth II anastomosis	Typical Billroth II anastomosis would be made after the Distal gastrectomy.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2016-05-05
• Last updated: 2017-07-21

Locations

1 site across 1 country: China