The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer
Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure. Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.
Ajou University Hospital
Suwon, South Korea
RECRUITINGReflux of bile content
We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.
Time frame: 6 months after surgery
Quality of Life
We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC).
Time frame: 6 months after surgery
Morbidity
We investigate the occurrence of complication during recovery after surgery.
Time frame: 2 month after surgery
Anastomotic time
We estimate anastomosis time
Time frame: Day 1
Nutritional state
We estimate Albumin, transferrin, lymphocyte, body weight
Time frame: 6 month after surgery
Mortality
We investigate the occurrence of operation-related death during recovery after surgery.
Time frame: 2 month after operation
Operation time
We estimate total operation time.
Time frame: Day 1
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