UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the extraction site location in laparoscopic colorectal surgery midline incision vs off midline incision Randomized controlled study
Acronym	Evaluation of the extraction site location in laparoscopic colorectal surgery RCT
Scientific Title	Evaluation of the extraction site location in laparoscopic colorectal surgery midline incision vs off midline incision Randomized controlled study
Scientific Title:Acronym	Evaluation of the extraction site location in laparoscopic colorectal surgery RCT
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will examine the location of small incision at laparoscopically assisted surgery by comparative test of random assignment for patients with colon cancer who can be expected to have curability by laparoscopic surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will evaluate the small incision in the first year after surgery using postoperative wound evaluation POSAS (patient and observer scar assessment scale).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	midline incision Extend the trocar hole in the umbilicus. Closure wound is suturing the white line and the peritoneum all together, suturing closure of the skin, compressing the cotton ball into the umbilicus.
Interventions/Control_2	off midline incision Extend the transrectus trocarshole. Closure wound closes the skin by suturing the peritoneum and the posterior sheath, suturing the rectus abdominis anterior sheath and suturing the skin.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	For anatomical colon cancer cases from ascending colon, descending colon, sigmoid colon and rectosigmoid colon cancer cases, 100 cases that satisfy the following conditions and were able to acquire consent in the document are targeted. Eligibility criteria 1 tumor is not more than 5 cm 2 There is no history of laparotomy 3 There is no ileus symptom
Key exclusion criteria	1 Psychosis or psychiatric symptoms are merged, and it is judged that participation in the examination is difficult. 2 Continuous systemic administration (ingestion or intravenous) of steroid drugs. 3 During treatment with insulin, or with poorly controlled diabetes mellitus. 4 Combined respiratory diseases requiring sustained oxygen administration. 5 There is no history of lower limb thrombosis. 6 Do not limit the concomitant medication. 7 When other medical doctor judges that participation in this examination is inappropriate.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katusnari Takifuji
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code
Address	811-1, Kimiidera, Wakayama, JAPAN
TEL	073-441-0613
Email	hiwa@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiromitsu Iwamoto
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code
Address	811-1, Kimiidera, Wakayama, JAPAN
TEL	073-441-0613
Homepage URL
Email	hiwa@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
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 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2014 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date	2014 Year 10 Month 16 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 31 Day
Date trial data considered complete	2019 Year 01 Month 31 Day
Date analysis concluded	2019 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 31 Day
Last modified on	2022 Year 07 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033097