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OpenTrials
Completed

NCT Number: NCT03356626

Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

Completed

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

  • post operative 2nd day CRP level
  • post operative 4th day CRP level
  • post operative IL-6, 10 level in 2nd, 4th day

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • pathologically proven adenocarcinoma in stomach
  • patients who are expected for R0 resection with distal gastrectomy
  • pre-operative clinical stage should be stage I
  • patients who is able to be followed up with in postoperative 30 days
  • patients whose CRP is normal before surgery

Exclusion criteria

  • patients who had an abdominal surgery
  • patients who received chemotherapy, radiotherapy before surgery
  • patients who received ESD before surgery
  • Patients who had an ascites on pre-operative CT scan
  • liver cirrhosis
  • cardiovascular disease (Ejection Fraction<50%)
  • serum creatinine > 1.4 mg/dL or BUN>26mg/dL
  • PT INR >1.2 or aPTT>45sec
  • uncontrolled diabetes
  • Crohn's disease, ulcerative colitis
  • patients who receives anti-coagulants
  • patients who need pre-operative steroid booster because of steroid treatment
  • pregnancy
  • patients who have allergic reaction to iodine

Treatment and study plan

ULTRACISION Harmonic Scalpel

Device

to use ULTRACISION Harmonic Scalpel when performing gastrectomy

Ligasure Maryland

Device

to use Ligasure Maryland when performing gastrectomy

THUNDERBEAT

Device

to use Thunderbeat when performing gastrectomy

Primary outcomes

  1. Postoperative 2nd Day CRP

    Time frame: 2nd day

    To check the postoperative 2nd day CRP level in each group

Secondary outcomes

  1. Postoperative 4th Day CRP

    Time frame: 4th day

    To check the postoperative 4th day CRP level in each group

  2. Postoperative 2nd Day IL-6

    Time frame: 2nd day

    To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

  3. Postoperative 4th Day IL-6

    Time frame: 4th day

    To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

  4. Postoperative 2nd Day IL-10 Level

    Time frame: 2nd day

    To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

  5. Postoperative 4th Day IL-10 Level

    Time frame: 4th day

    To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Medtronic Spine LLC

Registry information

Official study title

Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 29, 2017
Registry last updated
Sep 23, 2024

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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