UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A challenge between surgical resident education and patient safety in laparoscopic colorectal surgery
Title of the study (Brief title)	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	Akinobu Taketomi
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological Surgery I
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	Shigenori Homma
Organization	Hokkaido University Hospital
Division name	Gastroenterological Surgery I
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	When supervised and led by an expert laparoscopic surgeon, surgical residents are capable of performing laparoscopic surgery without negative effects on outcomes.
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/icdr_e/ctr_view.cgi?recptno=R000029704