UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001190 |
|---|---|
| Receipt number | R000001454 |
| Scientific Title | Health-related quality of life and well being of post-operative colon cancer patients with laparoscopic and laparotomic surgery |
| Date of disclosure of the study information | 2008/06/20 |
| Last modified on | 2008/06/15 16:30:00 |
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Basic information
Public title
Health-related quality of life and well being of post-operative colon cancer patients with laparoscopic and laparotomic surgery
Acronym
QLLC-J
Scientific Title
Health-related quality of life and well being of post-operative colon cancer patients with laparoscopic and laparotomic surgery
Scientific Title:Acronym
QLLC-J
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparing health-related quality of life and well being of the patients with Stage 2 or 3 colon cerncers who underwent laparoscopic and laparotomic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related quality of life
Key secondary outcomes
duration period from surgery to recovery to usual activity of daily living
general well being
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosed as colon cancer with pathologic evaluation
Tumors were located on cecum (C), assending colon (A), sigmoid colon (S), or sigmoid rectum (Rs).
There is no multiple lesions (Carcinoma in situ or intramucus lesions were not indicated as multiple lesions).
Clinically diagnosed as stage 2 or 3 colon cancer by preoperative evaluations
Diameter of target tumor is below 8cm.
Patients have no ileus symptom.
Ther is no past history of chemotherapy and radiation therapy.
Patients cover all preoperative laboratory findings.
-WBC>3000
-Plt>100,000
-GOT<100
-GPT<100
-T-Bil<2.0
-Cr<1.5
Informed consent is obtained.
Key exclusion criteria
Active double cancer.
Patients with possible pregnancy.
Patients have depression or other psychiatric disorders.
Patients have emphysema or pulmonary fibrosis.
Patients take steroid medications for 4 weeks or over.
Target sample size
375
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Matsumoto |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Surgery
Zip code
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-3411-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Bito |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division of Cilical Epidemiology
Zip code
Address
TEL
Homepage URL
bitoseiji@kankakuki.go.jp
Sponsor or person
Institute
Japanese Society for Endoscopic Surgery
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Endoscopic Surgery
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 06 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
eligible patients who underwent laparoscopic or laparotomic surgery are followed up with questionnaire survey. The questionnaire include SF-36 and other several questions asking patients' general life well being. Some other information such as patient surgery report and adverse events are recorded from medical records.
Management information
Registered date
| 2008 | Year | 06 | Month | 15 | Day |
Last modified on
| 2008 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
