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Completed

NCT Number: NCT01938326

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

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)

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinically early gastric cancer, potentially possible to perform distal gastrectomy (cancer in the distal 2/3rds)
  • 20< Age < 80

Exclusion criteria

  • history of other malignancy
  • received preoperative chemotherapy

Treatment and study plan

Approach Method

Procedure

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 outcomes

  1. Maximum pain score using VAS at postoperative day#1

    Time frame: Postoperative day 1

    Maximum postoperative pain using the visual analogue scale

Secondary outcomes

  1. Operation time

    Time frame: Time during operation

    Time spent during operation

  2. Estimated blood loss

    Time frame: During operation

    Amount of blood loss during operation

  3. Early postoperative complication

    Time frame: within 30 days from the operation

    Postoperative complications within 30 days from the operation

  4. Hospital stay

    Time frame: Days until discharge

    Days until discharge

  5. Time to first flatus

    Time frame: Days until first flatus

    Days until first flatus

  6. Time to first soft fluid diet

    Time frame: Days until first soft fluid diet

    Days until first soft fluid diet

  7. Maximum pain scores using VAS

    Time frame: From postoperative day 0 to 5

    Maximum pain scores using the visual analogue scale

  8. EORTC-C30 and STO22

    Time frame: Preoperative, 2 weeks after surgery, 1 month after surgery, 6 months after surgery, 12 months after surgery

    Quality of life questionnaires

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Postoperative Pain and Quality of Life After Single-incision Distal Gastrectomy Versus Totally Laparoscopic Distal Gastrectomy for Early Gastric Cancer - a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2013
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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