The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Procedure: Totally Laparoscopic Total Gastrectomy; Procedure: Laparoscopy-Assisted Total Gastrectomy

• Registration Number: NCT04351321
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-17
• Last Update Posted: 2020-04-17
• Study Start: 2020-07
• Primary Completion: 2022-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

1. Aged 18-75 years；
2. Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
3. Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
4. The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
5. BMI(Body Mass Index)<30 kg/m2；
6. No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
8. Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
9. Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
10. Sufficient vital organ functions；
11. Signed informed consent.

Exclusion Criteria

1. Preoperative examination indicates disease stage cStage II or above；
2. Women during pregnancy or lactation；
3. Suffer from other malignant tumors within 5 years；
4. Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
5. Severe mental illness；
6. Severe respiratory disease；
7. Severe liver and kidney dysfunction；
8. History of unstable angina or myocardial infarction within 6 months；
9. History of cerebral infarction or cerebral hemorrhage within 6 months；
10. Continuous application of glucocorticoid within 1 month (except for topical application)；
11. Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
12. The patient has participated in or is participating in other clinical studies (within 6 months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Totally Laparoscopic Total Gastrectomy	Totally Laparoscopic Total Gastrectomy	Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group.
Laparoscopy-Assisted Total Gastrectomy	Laparoscopy-Assisted Total Gastrectomy	Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative morbidity	30 days	Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.

Secondary Outcome Measures

Name	Time	Method
Overall incidence of postoperative morbidity	12 months	Refers to the incidence of overall postoperative complications observed during follow-up period.
Quality of life score	3, 6 and 12 months	Quality of life scores of the patients are evaluated based on STO22 questionnaire at the 3rd, 6th and 12th months after operation.