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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05035446
Enrollment
120
Registered
2021-09-05
Start date
2021-10-01
Completion date
2022-08-31
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Interventions

PROCEDUREsingle-incision plus one-port laparoscopic surgery

The investigators use the technique of adding one operation hole on the basis of single-port laparoscopy in some patients.

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

Sponsors

Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of complicationsIt is within 30 days after surgeryIt means the rate of intraoperative and postoperative complications

Secondary

MeasureTime frameDescription
Rate of deathIt is within 30 days after surgeryIt means the rate of death after operation
pain intensity1-3 days after operationThe investigators use Visual analogue scale(VAS) to evaluate the intensity of pain

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026