NCT01309256

Brief Summary

Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison with laparoscopic gastrectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

March 4, 2011

Last Update Submit

June 1, 2013

Conditions

Gastric Cancer

Keywords

distal gastrectomyRobotic gastrectomyregistrylearning curvecost-effectivenessquality of lifeacute inflammatory reactionRobotic and laparoscopic surgery

Outcome Measures

Primary Outcomes (5)

  • Registration of all robotic gastrectomies performed in South Korea

    at the end of the study

  • Learning curve (operation time and surgical outcome) of robotic gastrectomy

    from the start of the operation to discharge of the patient (usually two weeks after the operation)

  • Cost-effectiveness comparison between robotic and laparoscopic gastrectomy

    from admission to discharge of the patient (usually from two days before the operation until two weeks after the operation)

  • Quality of life after robotic and laparoscopic gastrectomy

    One day before operation, first OPD visit after the operation (two weeks after the operation), 3M, 12M, 36M, and 60M after the operation

  • Acute-inflammatory response after undergoing robotic and laparoscopic gastrectomy

    preop, 2hr, 24hr, 4days and 30 days after the operation

Study Arms (3)

R-robot group

retrospective robot group

P-robot group

prospective robot group

P-laparoscopic group

prospective laparoscopic group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gastric cancer patients

You may qualify if:

  • Patients must have documented diagnosis of gastric cancer
  • Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by preoperative CT-scan, upper endoscopy, and endoscopic ultrasound.
  • Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study
  • \- Any patients who underwent robotic gastrectomy in Korea

You may not qualify if:

  • Patients without mental competence
  • Patients who are illiterate
  • Patients who are pregnant
  • Patients \< 20 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (9)

  • Song J, Oh SJ, Kang WH, Hyung WJ, Choi SH, Noh SH. Robot-assisted gastrectomy with lymph node dissection for gastric cancer: lessons learned from an initial 100 consecutive procedures. Ann Surg. 2009 Jun;249(6):927-32. doi: 10.1097/01.sla.0000351688.64999.73.

    PMID: 19474671BACKGROUND

  • Song J, Kang WH, Oh SJ, Hyung WJ, Choi SH, Noh SH. Role of robotic gastrectomy using da Vinci system compared with laparoscopic gastrectomy: initial experience of 20 consecutive cases. Surg Endosc. 2009 Jun;23(6):1204-11. doi: 10.1007/s00464-009-0351-4. Epub 2009 Mar 5.

    PMID: 19263147BACKGROUND

  • Kim MC, Heo GU, Jung GJ. Robotic gastrectomy for gastric cancer: surgical techniques and clinical merits. Surg Endosc. 2010 Mar;24(3):610-5. doi: 10.1007/s00464-009-0618-9. Epub 2009 Aug 18.

    PMID: 19688399BACKGROUND

  • Song J, Lee HJ, Cho GS, Han SU, Kim MC, Ryu SW, Kim W, Song KY, Kim HH, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Recurrence following laparoscopy-assisted gastrectomy for gastric cancer: a multicenter retrospective analysis of 1,417 patients. Ann Surg Oncol. 2010 Jul;17(7):1777-86. doi: 10.1245/s10434-010-0932-4. Epub 2010 Feb 12.

    PMID: 20151217BACKGROUND

  • Lee HJ, Kim HH, Kim MC, Ryu SY, Kim W, Song KY, Cho GS, Han SU, Hyung WJ, Ryu SW; Korean Laparoscopic Gastrointestinal Surgery Study Group. The impact of a high body mass index on laparoscopy assisted gastrectomy for gastric cancer. Surg Endosc. 2009 Nov;23(11):2473-9. doi: 10.1007/s00464-009-0419-1. Epub 2009 Apr 3.

    PMID: 19343439BACKGROUND

  • Kim MC, Kim W, Kim HH, Ryu SW, Ryu SY, Song KY, Lee HJ, Cho GS, Han SU, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Risk factors associated with complication following laparoscopy-assisted gastrectomy for gastric cancer: a large-scale korean multicenter study. Ann Surg Oncol. 2008 Oct;15(10):2692-700. doi: 10.1245/s10434-008-0075-z. Epub 2008 Jul 29.

    PMID: 18663532BACKGROUND

  • Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.

    PMID: 20160637BACKGROUND

  • Kim MS, Kim WJ, Hyung WJ, Kim HI, Han SU, Kim YW, Ryu KW, Park S. Comprehensive Learning Curve of Robotic Surgery: Discovery From a Multicenter Prospective Trial of Robotic Gastrectomy. Ann Surg. 2021 May 1;273(5):949-956. doi: 10.1097/SLA.0000000000003583.

    PMID: 31503017DERIVED

  • Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.

    PMID: 26020107DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2011

First Posted

March 7, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

KR(1)