UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025815 |
|---|---|
| Receipt number | R000029683 |
| Scientific Title | Trial of mechanical bowel preparation in laparoscopic colorectal surgery with Moviprep |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2021/07/28 14:26:08 |
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Basic information
Public title
Trial of mechanical bowel preparation in laparoscopic colorectal surgery with Moviprep
Acronym
TLUMP
Scientific Title
Trial of mechanical bowel preparation in laparoscopic colorectal surgery with Moviprep
Scientific Title:Acronym
TLUMP
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of bowel preparation using Asc-PEG compared to PEG-ELS in laparoscopic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The availability of bowel irrigation effect confirmed by laparoscope
Key secondary outcomes
a. Dilatation of small and large bowel
b. Duration of bowel preparation
c. Duration between the begin of taking Asc-PEG/PEG-ELS and the first evacuation
d. Dose of Asc-PEG/PEG-ELS
e. Patients' acceptability
f. Recover of bowel movement
g. Recover of patients' activity
h. Conversion rate to open surgery
i. Safety
j. Postoperative inflammation response
k. Differential analysis (tumor location, clinical classification, PS, age, gender,condition of evacuation, condition of taking Asc-PEG/PEG-ELS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To take 1L of Asc-PEG + 0.5L of water the day before surgery
Interventions/Control_2
To take 2L of PEG-ELS the day before surgery
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patiens with colorectal cancer who are going to undergo laparoscopic surgery
2. Adenocarcinoma
3. Resectable primary lesion
4. Operative general condition
5. Age between 20 and 85
6. ECOG Performance Status between 0 and 2
7. Adequate informed consent
Key exclusion criteria
1. Obstruction of gastrointestinal tract
2. Perforation of gastrointestinal tract
3. Discharge deficiency of stomach
4. Toxic megacolon
5. Deficiency of G-6-PD
6. Renal failure
7. Severe inflammatory bowel disease
8. Bowel stenosis
9. Disorder of vomiting reflux
10. Dehydration
11. Severe heart or liver disease
12. Anemia owing to tumor bleeding
13. Double cancer
14. Total parenteral nutrition
15. Preoeprative treatment (chemotherapy, radiotherapy, immunothrapy)
16. Uncontrollable diabetes mellitus
17. Severe lung disease
18. Drug allergy
19. Pregnancy
20. Unfitness judged by doctors
Target sample size
188
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
0608638
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Homma |
Organization
Hokkaido University Hospital
Division name
Gastroenterological Surgery I
Zip code
0608648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
Homepage URL
homma.s@nifty.com
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine, Gastroenterologial Surgery I
Institute
Department
Personal name
Funding Source
Organization
EA Pharma, Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Clinical Research Review Board
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7934
recjimu@huhp.hokudai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs011180005
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）、JA北海道厚生連札幌厚生病院（北海道）、岩見沢市立総合病院（北海道）、KKR札幌医療センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
188
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
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 23 | Day |
Last modified on
| 2021 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029683
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