NCT05035446
Unknown
Phase 3
A Prospective Randomized Controlled Study of the Short-term Efficacy of Single-hole Plus One-hole Total Laparoscopic Surgery Versus Five-hole Total Laparoscopic Surgery for Distal Gastric Cancer
ConditionsSurgery
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Rate of complications
- Last Updated
- 4 years ago
Overview
Brief Summary
To evaluate the short-term outcomes of single-incision plus one-port laparoscopic surgery (SILS + 1) versus conventional laparoscopic surgery(CLS) for distal gastric cancer whose clinical stage was cT1-3N0-2M0
Detailed Description
The gastric cancer patients with cT1-3N0-2M0 were randomized at a 1:1 ratio to the CLS group or the SILS+1group, then it will evaluate the short-term outcomes between two groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •pathological diagnosis of gastric cancer
- •clinically diagnosed cT1b-3N0-2M0 lesions according to the 8th Edition of the American Joint Committee on Cancer(AJCC) Cancer Staging Manual(measured using abdominal CT)
- •tumor size ≤ 5cm
- •planned to conduct subtotal gastrectomy
Exclusion Criteria
- •preoperative radiotherapy and chemotherapy
- •tumor perforation
- •severe mental disease
Outcomes
Primary Outcomes
Rate of complications
Time Frame: It is within 30 days after surgery
It means the rate of intraoperative and postoperative complications
Secondary Outcomes
- pain intensity(1-3 days after operation)
- Rate of death(It is within 30 days after surgery)
Study Sites (1)
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