Anastomosis, Minimally Invasive Surgery, Stomach Neoplasms
Conditions
Keywords
Roux-en-Y Anastomosis, laparoscopic surgery, minilaparotomy, stomach neoplasms
Brief summary
* To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed. * To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently. * However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.
Interventions
PROCEDUREIntracorporeal Roux-en-Y esophagojejunostomy
During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed.
PROCEDUREExtracorporeal Roux-en-Y esophagojejunostomy
During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Age from over 18 to under 75 years * Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy * Tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery * Tumor invasion is less than 3cm above the esophagogastric junction * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) score class I, II, or III * Written informed consent
Exclusion criteria
* Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * Conversion to open surgery before reconstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomosis-related early complication rate | 30 days | Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis-related early complication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reconstruction time | During operation | Experimental group (Intracorporeal group): time from the esophagus was transected to reconstruction was completed. Active Comparator (Extracorporeal group): time from the minilaparotomy was made to reconstruction was completed. |
| Morbidity and mortality rates | 30 days | The early postoperative complication was defined as the event observed within 30 days after surgery. |
| Postoperative recovery course | 2 weeks | Time to first ambulation, flatus, liquid diet, soft diet, and postoperative hospital stay were used to assess the postoperative recovery course. |
| Postoperative quality of life | 6 months | EORTC questionaire (STO-22 and C30) were used to access the postoperative quality of life at 0,1,3,6 months after surgery. |
Countries
China
Contacts
Primary ContactGuoxin Li, M.D., Ph.D.
Backup ContactYanfeng Hu, M.D
Outcome results
None listed