Clinical trial NCT05035446: Short-term Outcomes of SILS+1 Versus CLS for Distal Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Surgery
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of complications
timeFrame: It is within 30 days after surgery
Secondary outcomes:
measure: Rate of death
timeFrame: It is within 30 days after surgery
measure: pain intensity
timeFrame: 1-3 days after operation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
Study officials:
References:
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