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

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05035446
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: single-incision plus one-port laparoscopic surgery
  • Procedure: conventional laparoscopic surgery
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: single-incision plus one-port laparoscopic surgery(SILS + 1)

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

Procedure: single-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.
Other: conventional laparoscopic surgery(CLS)

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

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

Outcome Measures

Primary Outcome Measures

  1. Rate of complications [It is within 30 days after surgery]

    It means the rate of intraoperative and postoperative complications

Secondary Outcome Measures

  1. Rate of death [It is within 30 days after surgery]

    It means the rate of death after operation

  2. pain intensity [1-3 days after operation]

    The investigators use Visual analogue scale(VAS) to evaluate the intensity of pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Cancer Hospital Fuzhou Fujian China 350014

Sponsors and Collaborators

  • Fujian Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fujian Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05035446
Other Study ID Numbers:
  • SILS+1-GC-001
First Posted:
Sep 5, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Oct 11, 2021