Stomach Neoplasm
Conditions
Brief summary
There is no consensus on what type of function-preserving gastrectomy can provide the best patient quality of life (QOL). This study aims to evaluate the incidence of dumping syndrome after vagus nerve-preserving distal gastrectomy (VPNDG).
Detailed description
The study is designed as a prospective observational phase II study with a follow-up period of 12 months. Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach who are planned to undergo laparoscopic VPNDG with Roux-en Y gastrojejunostomy will be enrolled. Primary endpoint is incidence of dumping syndrome defined by Sigstad score 7 after a 3-month interval. Other outcomes include operative data, early complication, and patient QOL using the European Organization for Research and Treatment of Cancer C-30 and STO22 modules.
Interventions
PROCEDUREVagus nerve-preserving distal gastrectomy
Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.
Sponsors
Seoul National University Bundang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach planned to undergo laparoscopic vagus nerve-preserving distal gastrectomy
Exclusion criteria
* Sacrificed vagus nerve * Anastomosis other than Roux-en Y gastrojejunostomy or uncut Roux-en Y gastrojejunostomy * conversion to an open procedure * combined resection of other organs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dumping syndrome | 1 year | Sigstad score of equal or more than 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC C-30/STO22 | 3 months, 6 months, 1 year | Quality of life surveys |
| Postoperative complication | 3 months, 6 months, 1 year | incidence of postoperative complication |
| Incidence of gallstones | 1 year | Found in follow-up CT or ultrasound |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Immediately after operation | Time of operation |
| Estimated blood loss | Immediately after operation | Blood loss during operation |
| Time to first flatus | Within 1 week | Postoperative day to first flatus |
| Hospital stay | Within 1 week | Total hospital stay |
Countries
South Korea
Outcome results
None listed