The primary aim of this trial is to rigorously evaluate the comparative benefits and potential risks associated with Billroth II reconstruction with Braun anastomosis versus Billroth II reconstruction alone following distal gastrectomy with D2 lymphadenectomy in patients diagnosed with gastric cancer. This assessment focuses on delineating the therapeutic efficacy, safety profile, and overall clinical outcomes of these two surgical approaches in treating this condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
Billroth II reconstruction, in which a loop of jejunum is mobilized and anastomosed to the gastric remnant
This is an additional surgical connection (anastomosis) created between two parts of the small intestine, specifically between the afferent (incoming) and efferent (outgoing) limbs of the jejunum near the gastrojejunostomy (the new connection between the stomach and small intestine created during a Billroth II procedure).
Incidence of reflux gastritis assessed according to RGB classification
by endoscopic evaluation
Time frame: 6 months, 12 months
Quality of life assessed by the PGSAS-45 Scale
The preoperative and postoperative QoL of patients between the two groups.
Time frame: 6 months, 12 months
Nutritional status
Changes in body weight (kg) or BMI from baseline
Time frame: 6 months, 12 months
Time to first passage of flatus/stool
Time taken to pass first stool or flatus
Time frame: within 30 days after surgery
Postoperative complications (assessed according to the Clavien-Dindo)
e.g., anastomotic leakage, anastomotic bleeding assessed by laboratory test in combination with clinical features, radiological diagnostic methods, endoscopy, diagnostic laparoscopy.
Time frame: within 30 days after surgery
Long-term complications
e.g., food residue and bile reflux (assessed according to the RGB classification).
Time frame: 6 months, 12 months
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