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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025829
Receipt No. R000029704
Scientific Title A challenge between surgical resident education and patient safety in laparoscopic colorectal surgery
Date of disclosure of the study information 2017/01/24
Last modified on 2018/07/27

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Basic information
Public title A challenge between surgical resident education and patient safety in laparoscopic colorectal surgery
Acronym A challenge between surgical resident education and patient safety in laparoscopic colorectal surgery
Scientific Title A challenge between surgical resident education and patient safety in laparoscopic colorectal surgery
Scientific Title:Acronym A challenge between surgical resident education and patient safety in laparoscopic colorectal surgery
Region
Japan

Condition
Condition Right side colon tumor
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the residents' educational program of laparoscopic sugery
Basic objectives2 Others
Basic objectives -Others Validity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. The required time for the task of tie and ligation
2. Perioperative factors (operation time, blood loss, complications, postoperative hospital stay)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent laparoscopic ileocecal resection or right-hemi coloectomy in the Department of Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine between January 2009 and July 2014.
Key exclusion criteria 1. reduced port surgery
2. other organ resection
3. inadequacy judged by principal invastigator
Target sample size 78

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinobu Taketomi
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological Surgery I
Zip code
Address Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5927
Email taketomi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigenori Homma
Organization Hokkaido University Hospital
Division name Gastroenterological Surgery I
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5927
Homepage URL
Email homma.s@nifty.com

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
When supervised and led by an expert laparoscopic surgeon, surgical residents are capable of performing laparoscopic surgery without negative effects on outcomes.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <Study design> A retrospective comparative study

Within a uniform learning curve for procedural training, we identified 6 different steps for each curriculum, from basic skills up to certification. Surgical residents are developing the basic technical skills of laparoscopic surgery early in their training pathway. This approach aims to enable the trainee to acquire competence in a stepwise fashion. Initially, surgical residents are required to perform basic laparoscopic procedures such as suture and knot tying technique in dry-box. Next, surgical residents are required to learn basic laparoscopic skills and safety measures in the skills laboratory, and also required to attend specific procedural animal training in skills laboratory. Moreover, surgical residents are required to learn patient positioning, equipment set-up, port placement, identification and division of vascular pedicles, identification of anatomical planes for full mobilization of the colon and flexures, visualization and preservation of all retroperitoneal structures, incision and specimen extraction and anastomosis. They are also encouraged to view a collection of video recordings of colorectal resections. Finally, surgical residents were uniformly required to use the standardized techniques to achieve mobilization of the colon and proximal ligation and division of the feeding artery, and transection and reconstruction of the colon.

Management information
Registered date
2017 Year 01 Month 24 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029704

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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