UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006644 |
|---|---|
| Receipt number | 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 15:23:19 |
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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
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
onsuzuki@tkeijinkai.gr.jp
Sponsor or person
Institute
Teine-Keijinkai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007858
