Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux

Shanghai Minimally Invasive Surgery Center

Status: Unknown

Conditions: Postoperative Complications; Gastric Cancer

Treatments: Procedure: Antiperistaltic Billroth II + Braun anastomosis; Procedure: Isoperistaltic Billroth II + Braun anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03372681

ShanghaiMISC-B2+Braun

Details and patient eligibility

About

Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically diagnosed as gastric cancer before surgery
• Clinical staging: cT1-4aN0-3M0
• Postoperative evaluation concluded B-II B anastomosis
• Consent assigned

Exclusion criteria

• Diagnosed with other malignancies within 2 years
• Gastric cancer with clinical staging: cT4b or M1
• Women with pregnancy or breast-feeding
• Emergency procedures
• Consent not assigned

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

Antiperistaltic

Experimental group

Description:

In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis

Treatment:

Procedure: Antiperistaltic Billroth II + Braun anastomosis

Isoperistaltic

Active Comparator group

Description:

In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis

Treatment:

Procedure: Isoperistaltic Billroth II + Braun anastomosis