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

NCT ID: NCT04972149

Last Updated: 2021-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-18

Study Completion Date

2022-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer Patients Undergoing Gastrectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LC

laparoscopic surgery using conventional laparoscopic instruments

No interventions assigned to this group

LW

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

No interventions assigned to this group

RC

Conventional robotic surgery

No interventions assigned to this group

RSS

Use of single site system for reduced port robotic surgery

No interventions assigned to this group

RSP

Use of da Vinci SP system for reduced port robotic surgery

No interventions assigned to this group

RRI

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients with gastric cancer scheduled for gastrectomy

Exclusion Criteria

Vulnerable subject (illiterate, pregnant)
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyoung-Il Kim

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hyoung-Il Kim

Role: CONTACT

82-2-2228-2095

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hyoung-Il Kim

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30734023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22076206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20160637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23207683 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8180768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22318810 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28205030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30809728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22941345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22508669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23468046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28357674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22664559 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2021-0409

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Compliance to ERAS After Gastric Surgery
NCT01653496 COMPLETED PHASE2