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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025815
Receipt No. 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 2018/07/27

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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
Middle name
Last name Akinobu Taketomi
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological Surgery I
Zip code
Address Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5927
Email taketomi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigenori Homma
Organization Hokkaido University Hospital
Division name Gastroenterological Surgery I
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5927
Homepage URL
Email homma.s@nifty.com

Sponsor
Institute Hokkaido University Graduate School of Medicine, Gastroenterologial Surgery I
Institute
Department

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
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 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 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
2017 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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
2017 Year 01 Month 23 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029683

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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