UMIN-CTR Clinical Trial

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

Right side colon tumor

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hokkaido University

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2017

Year

01

Month

24

Day

Last modified on

2018

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029704