search
Back to results

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

Primary Purpose

Surgery

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
single-incision plus one-port laparoscopic surgery
conventional laparoscopic surgery
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fujian Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

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

conventional laparoscopic surgery(CLS)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of complications
It means the rate of intraoperative and postoperative complications

Secondary Outcome Measures

Rate of death
It means the rate of death after operation
pain intensity
The investigators use Visual analogue scale(VAS) to evaluate the intensity of pain

Full Information

First Posted
August 26, 2021
Last Updated
October 4, 2021
Sponsor
Fujian Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05035446
Brief Title
Short-term Outcomes of SILS+1 Versus CLS for Distal Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

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

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-incision plus one-port laparoscopic surgery(SILS + 1)
Arm Type
Experimental
Arm Description
It requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy
Arm Title
conventional laparoscopic surgery(CLS)
Arm Type
Other
Arm Description
It requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy
Intervention Type
Procedure
Intervention Name(s)
single-incision plus one-port laparoscopic surgery
Intervention Description
The investigators use the technique of adding one operation hole on the basis of single-port laparoscopy in some patients.
Intervention Type
Procedure
Intervention Name(s)
conventional laparoscopic surgery
Intervention Description
It usually requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy.
Primary Outcome Measure Information:
Title
Rate of complications
Description
It means the rate of intraoperative and postoperative complications
Time Frame
It is within 30 days after surgery
Secondary Outcome Measure Information:
Title
Rate of death
Description
It means the rate of death after operation
Time Frame
It is within 30 days after surgery
Title
pain intensity
Description
The investigators use Visual analogue scale(VAS) to evaluate the intensity of pain
Time Frame
1-3 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhao Teng
Phone
13600815361
Email
fjtengwh@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30178393
Citation
Kunisaki C, Miyamoto H, Sato S, Tanaka Y, Sato K, Izumisawa Y, Yukawa N, Kosaka T, Akiyama H, Saigusa Y, Sakamaki K, Yamanaka T, Endo I. Surgical Outcomes of Reduced-Port Laparoscopic Gastrectomy Versus Conventional Laparoscopic Gastrectomy for Gastric Cancer: A Propensity-Matched Retrospective Cohort Study. Ann Surg Oncol. 2018 Nov;25(12):3604-3612. doi: 10.1245/s10434-018-6733-x. Epub 2018 Sep 3.
Results Reference
background
PubMed Identifier
25159658
Citation
Kashiwagi H, Kumagai K, Monma E, Nozue M. Dual-port distal gastrectomy for the early gastric cancer. Surg Endosc. 2015 Jun;29(6):1321-6. doi: 10.1007/s00464-014-3827-9. Epub 2014 Aug 27.
Results Reference
background
PubMed Identifier
32884224
Citation
Zhou W, Dong CZ, Zang YF, Xue Y, Zhou XG, Wang Y, Ding YL. Initial experience of single-incision plus one port left-side approach totally laparoscopic distal gastrectomy with uncut Roux-en-Y reconstruction. World J Gastroenterol. 2020 Aug 21;26(31):4669-4679. doi: 10.3748/wjg.v26.i31.4669.
Results Reference
background
PubMed Identifier
25398519
Citation
Kunisaki C, Makino H, Kimura J, Takagawa R, Ota M, Kosaka T, Akiyama H, Endo I. Application of reduced-port laparoscopic total gastrectomy in gastric cancer preserving the pancreas and spleen. Gastric Cancer. 2015 Oct;18(4):868-75. doi: 10.1007/s10120-014-0441-4. Epub 2014 Nov 15.
Results Reference
background
PubMed Identifier
25564174
Citation
Kim SM, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S, Lee JH. Comparison of Reduced Port Totally Laparoscopic Distal Gastrectomy (Duet TLDG) and Conventional Laparoscopic-Assisted Distal Gastrectomy. Ann Surg Oncol. 2015 Aug;22(8):2567-72. doi: 10.1245/s10434-014-4333-y. Epub 2015 Jan 7.
Results Reference
background
PubMed Identifier
33545969
Citation
Yang X, Bu Z, He M, Lin Y, Jiang Y, Chen D, Liu K, Zhou J. Effectiveness and safety of reduced-port laparoscopic surgery vs conventional multi-port laparoscopic surgery in the treatment of gastric diseases: A meta-analysis. Medicine (Baltimore). 2021 Jan 22;100(3):e23941. doi: 10.1097/MD.0000000000023941.
Results Reference
background
PubMed Identifier
26694180
Citation
Kim SM, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S, Lee JH. Comparison of single-port and reduced-port totally laparoscopic distal gastrectomy for patients with early gastric cancer. Surg Endosc. 2016 Sep;30(9):3950-7. doi: 10.1007/s00464-015-4706-8. Epub 2015 Dec 22.
Results Reference
background
PubMed Identifier
29984067
Citation
Kim HG, Kim DY, Jeong O. Transition from Conventional to Reduced-Port Laparoscopic Gastrectomy to Treat Gastric Carcinoma: a Single Surgeon's Experience from a Small-Volume Center. J Gastric Cancer. 2018 Jun;18(2):172-181. doi: 10.5230/jgc.2018.18.e18. Epub 2018 Jun 27.
Results Reference
background
PubMed Identifier
31338689
Citation
Lu YM, Lin T, Hu YF, Liu H, Mou TY, Zhu Y, Yu J, Li GX. Initial Experience of Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer: A Single-Arm Study. Adv Ther. 2019 Sep;36(9):2342-2350. doi: 10.1007/s12325-019-01029-x. Epub 2019 Jul 23.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs