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

October 4, 2021 updated by: Fujian Cancer Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian cancer hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SILS+1-GC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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