Short-term Outcomes of SILS+1 Versus CLS for Distal Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgery

Intervention / Treatment
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* Procedure: single-incision plus one-port laparoscopic surgery
* Procedure: conventional laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-incision plus one-port laparoscopic surgery(SILS + 1)<br>It requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy | Procedure: single-incision plus one-port laparoscopic surgery<br>* The investigators use the technique of adding one operation hole on the basis of single-port laparoscopy in some patients.<br>|
| Other: conventional laparoscopic surgery(CLS)<br>It requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy | Procedure: conventional laparoscopic surgery<br>* It usually requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | It means the rate of intraoperative and postoperative complications | It is within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of death | It means the rate of death after operation | It is within 30 days after surgery | 
| pain intensity | The investigators use Visual analogue scale(VAS) to evaluate the intensity of pain | 1-3 days after operation |