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

Fujian Provincial Cancer Hospital

Status and phase: Unknown; Phase 3

Conditions: Surgery

Treatments: Procedure: conventional laparoscopic surgery; Procedure: single-incision plus one-port laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05035446

SILS+1-GC-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

single-incision plus one-port laparoscopic surgery(SILS + 1)

Experimental group

Description:

It requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy

Treatment:

Procedure: single-incision plus one-port laparoscopic surgery

conventional laparoscopic surgery(CLS)

Other group

Description:

It requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy

Treatment:

Procedure: conventional laparoscopic surgery