UMIN-CTR Clinical Trial

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
Email	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
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	Hokkaido University Clinical Research Review Board
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
Tel	011-706-7934
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029683