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

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01938326
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2017
• Anticipated Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

   EORTC and GIQLI questionnaire

5. Numerical rating scale (NRS) for cosmetic result [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 [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 [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 [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 [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 [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 [5 days after surgery (plus and minus 6 hours)]

    Pain assessment VAS (O: no pain, 10: worst pain, imaginable)

12. Postoperative complications [within the first 30 days after surgery]

    Postoperative complications assessed by Clavien-Dindo Classification

Secondary Outcome Measures

1. Acute inflammatory Response - Preoperative [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 [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 [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 [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sang-Hoon Ahn, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT01938326
• Other Study ID Numbers: SNUBH-SIDG-GS-PII
• First Posted: Sep 10, 2013
• Last Update Posted: Oct 9, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sang-Hoon Ahn, Professor, Seoul National University Bundang Hospital: Stomach neoplasm; TLDG; SIDG; single-port; inflammatory response
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Oct 9, 2019