Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Procedure: laparoscopy-assisted distal gastrectomy GroupProcedure: Totally laparoscopic distal gastrectomy
- Registration Number
- NCT05541783
- Lead Sponsor
- Fudan University
- Brief Summary
The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.
- Detailed Description
Although totally laparoscopic distal gastrectomy (TLDG) and laparoscopic-assisted distal gastrectomy (LADG) are both minimally invasive surgeries for gastric cancer with the same surgical treatment principles, in the former, all surgical processes are performed intracorporeally, while, in the latter, extracorporeal gastro-enteric anastomosis is achieved. Whether the procedural differences between TLDG and LADG affect quality of life （QOL）is still under debate.To evaluate how each laparoscopic surgery affect QOL of patients with gastric cancer, it is necessary to compare the postoperative QOL (scoring by questionnaire) between the patients undergoing TLDG and LADG through a multi-center randomized controlled trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- Aged 20-80 years;
- Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
- Patients had histologically confirmed gastric adenocarcinoma (tumor size<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition;
- Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.
- Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
- Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
- Patients had any concurrent or previous malignant tumor;
- Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
- Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopy-assisted distal gastrectomy laparoscopy-assisted distal gastrectomy Group The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction. Totally laparoscopic distal gastrectomy Totally laparoscopic distal gastrectomy The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.
- Primary Outcome Measures
Name Time Method Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire 30 days postoperatively Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively
- Secondary Outcome Measures
Name Time Method Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively 30 days postoperatively Scores on the other scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively
Scores on EORTC QLQ-C30 questionnaire 7 days and 90 days postoperatively Scores on EORTC QLQ-C30 questionnaire at 7 days and 90 days postoperatively
Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively 7，30 and 90 days postoperatively Scores on the scales of EORTC QLQ-STO22 questionnaire at 7，30 and 90 days postoperatively
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China