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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006644
Receipt No. R000007858
Scientific Title A case-matched comparison of single-incision versus multiport laparoscopic right colectomy for colon cancer
Date of disclosure of the study information 2011/11/01
Last modified on 2011/11/01

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Basic information
Public title A case-matched comparison of single-incision versus multiport laparoscopic right colectomy for colon cancer
Acronym A case-matched comparison of single-incision versus multiport laparoscopic colectomy
Scientific Title A case-matched comparison of single-incision versus multiport laparoscopic right colectomy for colon cancer
Scientific Title:Acronym A case-matched comparison of single-incision versus multiport laparoscopic colectomy
Region
Japan

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

Objectives
Narrative objectives1 To compare short-term clinicopathological and financial outcomes between single-incision laparoscopic right colectomy (SILC) and multiport laparoscopic right colectomy (LAC) for right colon cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The clinicopathological findings and financial outcomes were then analyzed between the two groups.
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Right colon cancer
Key exclusion criteria Colonic obstruction, perforation, remote metastasis, bulky mesenteric lymph nodes near the tumor, and involvement of the abdominal wall
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name On Suzuki
Organization Teine-Keijinkai Hospital
Division name Department of Surgery
Zip code
Address 1-jo, 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido
TEL +81-11-681-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Teine-Keijinkai Hospital
Division name Department of Surgery
Zip code
Address
TEL
Homepage URL
Email onsuzuki@tkeijinkai.gr.jp

Sponsor
Institute Teine-Keijinkai Hospital
Institute
Department

Funding Source
Organization None
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
2011 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2011 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Operative time was not significantly different in SILC compared with LAC. SILC patients, however, had a significantly earlier return of bowel movement, decreased scores for maximal pain assessed by a visual analogue scale on post-operative day 1, fewer usages of postoperative systemic narcotics, and shorter length of stay. Postoperative morbidity and blood test results were similar between the groups. Neither mortality nor 30-day readmission occurred in either group. Oncologic findings did not reach a significant difference between them. Although no significant difference in the costs of disposable instruments existed between the two groups, the total costs were significantly less in the SILC group.

Management information
Registered date
2011 Year 11 Month 01 Day
Last modified on
2011 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007858

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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