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Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)

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ClinicalTrials.gov Identifier: NCT01938326
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Sang-Hoon Ahn, Seoul National University Bundang Hospital

Brief Summary:
  1. Compare the immune response and postoperative complications between pure SIDG (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal gastrectomy) for early gastric cancer (EGC)
  2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)

Condition or disease Intervention/treatment Phase
Early Gastric Cancer Procedure: Approach Method Not Applicable

Detailed Description:

There are some trends of reducing the numbers and lengths of wounds in the fields of laparoscopic surgery.

Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been popular procedure in the treatment of gastric cancer. Furthermore, the report on early experience of SIDG, which has no incision except umbilicus port, is going to be published.

However, there've been no objective reports and data on real minimal invasiveness and benefits between 2 procedures. In this study, I would like to find out the benefits of the reducing port and wound size by comparing the above 2 procedures' immune response and postoperative complications.

This study is planned as a phase II study.

There are no references on this subject, so the investigators set the numbers of each groups into 30, which is minimal requirement for the parametric comparisons.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Study of Acute Inflammatory Reaction and Morbidity After Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Early Gastric Cancer.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: TLDG
No mini-laparotomy in the epigastrium Reconstruction by the uncut Roux-en Y gastrojejunostomy
Procedure: Approach Method
SIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery)

Active Comparator: SIDG
SIDG : pure single incision laparoscopic distal gastrectomy Reconstruction by the uncut Roux-en Y gastrojejunostomy
Procedure: Approach Method
SIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery)




Primary Outcome Measures :
  1. Quality of life - European organization for research and treatment of cancer (EORTC) & Gastrointestinal quality of life index (GIQLI) preoperative [ Time Frame: within 14 days before surgery ]
    EORTC and GIQLI questionnaire

  2. Quality of life - European organization for research and treatment of cancer (EORTC) & Gastrointestinal quality of life index (GIQLI) - postoperative 5 days [ Time Frame: 5 days after surgery (plus and minus 12 hours) ]
    EORTC and GIQLI questionnaire

  3. Quality of life - European organization for research and treatment of cancer (EORTC) & Gastrointestinal quality of life index (GIQLI) - postoperative 1 month [ Time Frame: 1 month after surgery (plus and minus 1 week) ]
    EORTC and GIQLI questionnaire

  4. Quality of life - European organization for research and treatment of cancer (EORTC) & Gastrointestinal quality of life index (GIQLI) - postoperative 3 months [ Time Frame: 3 months after surgery (plus and minus 1 week) ]
    EORTC and GIQLI questionnaire

  5. Numerical rating scale (NRS) for cosmetic result [ Time Frame: 1 month after surgery (plus and minus 1 week) ]
    Cosmetic result assessed by NRS (0~10, 0: worst - 10 : best, no scar)

  6. Numerical rating scale (NRS) for cosmetic result [ Time Frame: 3 month after surgery (plus and minus 1 week) ]
    Cosmetic result assessed by NRS (0~10, 0: worst - 10 : best, no scar)

  7. Visual analogue scale (VAS) for pain assessment - Postoperative 2hrs [ Time Frame: within 2 hours after surgery ]
    Pain assessment VAS (O: no pain, 10: worst pain, imaginable)

  8. Visual analogue scale (VAS) for pain assessment - Postoperative 1 day [ Time Frame: 1 day after surgery (plus and minus 6 hours) ]
    Pain assessment VAS (O: no pain, 10: worst pain, imaginable)

  9. Visual analogue scale (VAS) for pain assessment - Postoperative 2 days [ Time Frame: 2 days after surgery (plus and minus 6 hours) ]
    Pain assessment VAS (O: no pain, 10: worst pain, imaginable)

  10. Visual analogue scale (VAS) for pain assessment - Postoperative 3 days [ Time Frame: 3 days after surgery (plus and minus 6 hours) ]
    Pain assessment VAS (O: no pain, 10: worst pain, imaginable)

  11. Visual analogue scale (VAS) for pain assessment - Postoperative 5 days [ Time Frame: 5 days after surgery (plus and minus 6 hours) ]
    Pain assessment VAS (O: no pain, 10: worst pain, imaginable)

  12. Postoperative complications [ Time Frame: within the first 30 days after surgery ]
    Postoperative complications assessed by Clavien-Dindo Classification


Secondary Outcome Measures :
  1. Acute inflammatory Response - Preoperative [ Time Frame: within 1 weeks before surgery ]
    Check white blood cell (WBC) count, c-reactive protein (CRP), tumor necrosis factor (TNF)-a, interleukin (IL-6)

  2. Acute inflammatory Response - Postoperative 2 hours [ Time Frame: 2 hours after surgery (plus and minus 1 hours) ]
    Check white blood cell (WBC) count, c-reactive protein (CRP), tumor necrosis factor (TNF)-a, interleukin (IL-6)

  3. Acute inflammatory Response - Postoperative 2 days [ Time Frame: 2 days after surgery (plus and minus 6 hours) ]
    Check white blood cell (WBC) count, c-reactive protein (CRP), tumor necrosis factor (TNF)-a, interleukin (IL-6)

  4. Acute inflammatory Response - Postoperative 5 days [ Time Frame: 5 day after surgery (plus and minus 6 hours) ]
    Check white blood cell (WBC) count, c-reactive protein (CRP), tumor necrosis factor (TNF)-a, interleukin (IL-6)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically early gastric cancer, potentially possible to perform distal gastrectomy
  • 20< Age < 80
  • No severe comorbidity
  • No other malignancy
  • No Other cancer treatments
  • BMI < 23 in man, BMI < 25 in woman

Exclusion Criteria:

  • Other reconstruction method except Billroth I

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938326


Contacts
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Contact: Hyung-Ho Kim, M.D., Ph.D. +82-31-787-7097 hhkim@snubh.org
Contact: Sang-Hoon Ahn, M.D. +82-31-787-7106 viscaria@snubh.org

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of
Contact: Hyung-Ho Kim, M.D, Ph.D.    +82-31-787-7097    hhkim@snubh.org   
Contact: Sang-Hoon Ahn, M.D.    +82-31-787-7099    viscaria@snubh.org   
Principal Investigator: Hyung-Ho Kim, M.D., Ph.D.         
Sponsors and Collaborators
Seoul National University Bundang Hospital

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Responsible Party: Sang-Hoon Ahn, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01938326     History of Changes
Other Study ID Numbers: SNUBH-SIDG-GS-PII
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sang-Hoon Ahn, Seoul National University Bundang Hospital:
Stomach neoplasm
TLDG
SIDG
single-port
inflammatory response

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases