UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005297 |
|---|---|
| Receipt number | R000006295 |
| Scientific Title | The study of assessment for gastrointestinal motility function using radiopaque marker |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2018/04/04 09:57:38 |
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Basic information
Public title
The study of assessment for gastrointestinal motility function using radiopaque marker
Acronym
The study of assessment for gastrointestinal motility function using radiopaque marker
Scientific Title
The study of assessment for gastrointestinal motility function using radiopaque marker
Scientific Title:Acronym
The study of assessment for gastrointestinal motility function using radiopaque marker
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the recovery of postoperative gastrointestinal motility function by using radiopaque marker.
Basic objectives2
Others
Basic objectives -Others
It has been suggested that mechanical bowel preparation (MBP) is of no benefit in terms of anastomotic healing, infection rate, or improvement in postoperative course in patients undergoing elective colorectal surgery, indicating that MBP should be abandoned. However, the effect of MBP on postoperative gastrointestinal motility has been assessed subjectively. In this randomized trial, we assessed objectively the effect of MBP on postoperative gastrointestinal motility and mobility in elective colonic resection.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Transition and excretion rate of the radiopaque marker
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoprative mechanical bowel preparation
Interventions/Control_2
No preoperative mechanical preparation
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
This study included patients who underwent an elective open or laparoscope-assisted colonic resection (LAC) in our institute. All patients were invited to participate in this trial, which compared outcomes after surgery with or without preoperative MBP. General inclusion criteria were patients with (1) a primary tumor located from the cecum to the sigmoid colon and (2) an American Society of Anesthesiologists grade of I or II.
Key exclusion criteria
Exclusion criteria were a stoma, a complete intestinal obstruction that needed decompression, and a past history of another colonic resection.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Uchida |
Organization
Nippon Medical School
Division name
Department of surgery
Zip code
Address
Sendagi 1-1-5 Bunkyo-ku, Tokyo
TEL
03-3822-2131
uchida@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamada |
Organization
Nippon Medical School
Division name
Department of surgery
Zip code
Address
Sendagi 1-1-5 Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
y-tak@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Department of surgery
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2011 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
Management information
Registered date
| 2011 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006295
