Locally Advanced Gastric Cancer, Total Laparoscopic Distal Gastrectomy
Conditions
Brief summary
Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer
Interventions
PROCEDURETLDG or LADG
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of gastric cancer was confirmed by pathological examination * Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th * No accompany with another cancer * ECOG 0-1 * ASA I-III * Agreement
Exclusion criteria
* Pregnant or suckling period * Patients with a history of preoperative chemoradiotherapy * Patients with unable to finish D2 lymphadenectomy or R0 resection * Laparoscopic surgery contraindications * Serious organ disfunction * Accompany with serious mental disease * Continuous treatment with steroid in 1 month * Disagreement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative early anastomotic morbidity | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 30 days | estimated with EORTC QLQ-C30V3、EORTC QLQ-STO22 |
| Postoperative hospital stay | 30 days | — |
| Flatus time | 7 days | — |
| Postoperative inflammation response | 10 days | using C-reactive protein、IL-6、WBC and so on postoperative 1,3,5,7 days |
| Nutrition | 30 days | NRS-2002 and PG-SGA in 30 days |
| Pain score | 10 days | — |
Contacts
Primary ContactWeidong Zang, Associate chief physician
Backup ContactWenhao Teng, Doctor
Outcome results
None listed