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

Phase 3

• Conditions: Surgery
• Interventions: Procedure: conventional laparoscopic surgery; Procedure: single-incision plus one-port laparoscopic surgery

• Registration Number: NCT05035446
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2021-08-26
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-05
• Study Start: 2021-10-01
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11
• Primary Completion: 2022-07-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

• preoperative radiotherapy and chemotherapy
• tumor perforation
• severe mental disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional laparoscopic surgery(CLS)	conventional laparoscopic surgery	It requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy
single-incision plus one-port laparoscopic surgery(SILS + 1)	single-incision plus one-port laparoscopic surgery	It requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy

Primary Outcome Measures

Name	Time	Method
Rate of complications	It is within 30 days after surgery	It means the rate of intraoperative and postoperative complications

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China