NCT04972149

Brief Summary

A new surgical instrument is supposed to allow surgeon to do surgery with better performance. However, the learning period before getting used to the new instruments is necessary. The surgeon's stress to overcome the learning effect and the surgical outcome was rarely assessed. The comparative analysis of surgical outcome, surgeon's stress, and utilization of instruments for gastrectomy will be performed in prospective cohort study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

May 18, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2022

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

July 4, 2021

Last Update Submit

July 23, 2021

Conditions

Gastric Cancer Patients Undergoing Gastrectomy

Keywords

surgeon stressinstrumentoutcomecomplication

Outcome Measures

Primary Outcomes (1)

  • complication

    One of the most important surgical outcome, complication will be measured at 1 month after surgery

    1 month after surgery

Secondary Outcomes (8)

  • operative time (min)

    1 month after surgery

  • bleeding(ml)

    1 month after surgery

  • gas passing(day)

    1 month after surgery

  • hospital stay(day)

    1 month after surgery

  • readmission rate(percent)

    1 month after surgery

  • +3 more secondary outcomes

Study Arms (6)

LC

laparoscopic surgery using conventional laparoscopic instruments

LW

Using wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated grasper)

RC

Conventional robotic surgery

RSS

Use of single site system for reduced port robotic surgery

RSP

Use of da Vinci SP system for reduced port robotic surgery

RRI

A new surgical robot Revo-i developed by Meerae company in Korea

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with gastric cancer scheduled to undergo gastrectomy in high volume center

You may qualify if:

  • Patients with gastric cancer scheduled for gastrectomy

You may not qualify if:

  • Vulnerable subject (illiterate, pregnant)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Related Publications (13)

  • Grantcharov PD, Boillat T, Elkabany S, Wac K, Rivas H. Acute mental stress and surgical performance. BJS Open. 2018 Sep 27;3(1):119-125. doi: 10.1002/bjs5.104. eCollection 2019 Feb.

    PMID: 30734023BACKGROUND

  • Jeong O, Park YK. Clinicopathological features and surgical treatment of gastric cancer in South Korea: the results of 2009 nationwide survey on surgically treated gastric cancer patients. J Gastric Cancer. 2011 Jun;11(2):69-77. doi: 10.5230/jgc.2011.11.2.69. Epub 2011 Jun 30.

    PMID: 22076206BACKGROUND

  • 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 YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.

    PMID: 23207683BACKGROUND

  • Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.

    PMID: 8180768BACKGROUND

  • Lee JH, Kim KM, Cheong JH, Noh SH. Current management and future strategies of gastric cancer. Yonsei Med J. 2012 Mar;53(2):248-57. doi: 10.3349/ymj.2012.53.2.248.

    PMID: 22318810BACKGROUND

  • Lee S, Kim JK, Kim YN, Jang DS, Kim YM, Son T, Hyung WJ, Kim HI. Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial. Surg Endosc. 2017 Oct;31(10):4002-4009. doi: 10.1007/s00464-017-5435-y. Epub 2017 Feb 15.

    PMID: 28205030BACKGROUND

  • Liu ZY, Chen QY, Zhong Q, Xie JW, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Zheng CH, Huang CM, Li P. Is three-dimensional laparoscopic spleen preserving splenic hilar lymphadenectomy for gastric cancer better than that of two-dimensional? Analysis of a prospective clinical research study. Surg Endosc. 2019 Oct;33(10):3425-3435. doi: 10.1007/s00464-018-06640-7. Epub 2019 Feb 26.

    PMID: 30809728BACKGROUND

  • Niitsu H, Hirabayashi N, Yoshimitsu M, Mimura T, Taomoto J, Sugiyama Y, Murakami S, Saeki S, Mukaida H, Takiyama W. Using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale to evaluate the skills of surgical trainees in the operating room. Surg Today. 2013 Mar;43(3):271-5. doi: 10.1007/s00595-012-0313-7. Epub 2012 Sep 1.

    PMID: 22941345BACKGROUND

  • Pietrabissa A, Sbrana F, Morelli L, Badessi F, Pugliese L, Vinci A, Klersy C, Spinoglio G. Overcoming the challenges of single-incision cholecystectomy with robotic single-site technology. Arch Surg. 2012 Aug;147(8):709-14. doi: 10.1001/archsurg.2012.508.

    PMID: 22508669BACKGROUND

  • Vizza E, Corrado G, Mancini E, Baiocco E, Patrizi L, Fabrizi L, Colantonio L, Cimino M, Sindico S, Forastiere E. Robotic single-site hysterectomy in low risk endometrial cancer: a pilot study. Ann Surg Oncol. 2013 Aug;20(8):2759-64. doi: 10.1245/s10434-013-2922-9. Epub 2013 Mar 7.

    PMID: 23468046BACKGROUND

  • Yang SY, Roh KH, Kim YN, Cho M, Lim SH, Son T, Hyung WJ, Kim HI. Surgical Outcomes After Open, Laparoscopic, and Robotic Gastrectomy for Gastric Cancer. Ann Surg Oncol. 2017 Jul;24(7):1770-1777. doi: 10.1245/s10434-017-5851-1. Epub 2017 Mar 29.

    PMID: 28357674BACKGROUND

  • Zeng YK, Yang ZL, Peng JS, Lin HS, Cai L. Laparoscopy-assisted versus open distal gastrectomy for early gastric cancer: evidence from randomized and nonrandomized clinical trials. Ann Surg. 2012 Jul;256(1):39-52. doi: 10.1097/SLA.0b013e3182583e2e.

    PMID: 22664559BACKGROUND

Study Officials

  • Hyoung-Il Kim

    Yonsei University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung-Il Kim

CONTACT

82-2-2228-2095cairus@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 22, 2021

Study Start

May 18, 2021

Primary Completion

May 9, 2022

Study Completion

July 9, 2022

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)