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Gastric Cancer Patients Undergoing GastrectomyNCT04972149

Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy

An observational study of Gastric Cancer Patients Undergoing Gastrectomy, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 90 years
How many people
250 participants
Where
1 siteSouth Korea
Study dates
18 May 2021to 9 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Patients with gastric cancer scheduled for gastrectomy

Who cannot join

  • Vulnerable subject (illiterate, pregnant)

Trial locations and contacts

1 site in 1 country.

Hyoung-Il Kim contact

82-2-2228-2095

cairus@yuhs.ac

South Korea1 site, 1 recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul

    Hyoung-Il Kim

    Recruiting

Other trials in South Korea

About this study

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

Read the detailed description

Before the surgery, all the eligible patients will be explained regarding the study and informed consent will be given. During the surgery, the surgeon will wear heart rate monitoring device to monitor hear rate variability of the surgeon. The surgical procedure will be recorded. After the surgery, morbidity following surgery will be monitored and recorded. At 1 month after surgery, additional morbidity will be recorded.

Keywords
surgeon stress, instrument, outcome, complication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04972149
Study groupRoleWhat they receive
LClaparoscopic surgery using conventional laparoscopic instruments
LWUsing wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated grasper)
RCConventional robotic surgery
RSSUse of single site system for reduced port robotic surgery
RSPUse of da Vinci SP system for reduced port robotic surgery
RRIA new surgical robot Revo-i developed by Meerae company in Korea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complication

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

    Measured: 1 month after surgery

Secondary outcomes (8)

  1. operative time (min)

    Measured: 1 month after surgery

  2. bleeding(ml)

    Measured: 1 month after surgery

  3. gas passing(day)

    Measured: 1 month after surgery

  4. hospital stay(day)

    Measured: 1 month after surgery

  5. readmission rate(percent)

    Measured: 1 month after surgery

  6. Heart rate variability of surgeon

    Measured: during the operation

  7. Duration for each surgical instruments

    Measured: during the operation

  8. number of use for each surgical instruments

    Measured: during the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start18 May 2021
  3. Primary completion9 May 2022 (estimated)
  4. Study completion9 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04972149
Sponsor's protocol ID
4-2021-0409
Status last verified
Jul 2021
First submitted
4 Jul 2021
Last updated
26 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30734023

  • 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.

    PubMed 22076206

  • 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.

    PubMed 20160637

  • 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.

    PubMed 23207683

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

    PubMed 8180768

  • 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.

    PubMed 22318810

  • 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.

    PubMed 28205030

  • 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.

    PubMed 30809728

  • 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.

    PubMed 22941345

  • 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.

    PubMed 22508669

  • 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.

    PubMed 23468046

  • 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.

    PubMed 28357674

  • 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.

    PubMed 22664559

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer Patients Undergoing Gastrectomy, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyoung-Il Kim (82-2-2228-2095, cairus@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complication (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04972149, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.

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