UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043162 |
|---|---|
| Receipt number | R000049265 |
| Scientific Title | Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study |
| Date of disclosure of the study information | 2021/01/28 |
| Last modified on | 2023/08/02 21:00:02 |
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Basic information
Public title
Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study
Acronym
Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study
Scientific Title
Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study
Scientific Title:Acronym
Preoperative less painful mechanical bowel preparation in elective resection colorectal cancer surgery: a multicenter randomized non-Inferiority study
Region
| Japan |
Condition
Condition
left colon cancer, rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For all patients undergoing intestinal anastomosis in left-sided colon and rectal cancer surgery, the purpose of this study is to show that a less painful preoperative oral antibiotics and mechanical bowel preparation (mOAMBP (1 day method: 75.0 mg of sodium picosulfate hydrate the day before surgery, or 2 days method: 37.5 mg two days before surgery and 37.5 mg the day before surgery)) is non-inferior to the conventional preoperative oral antibiotics and mechanical bowel preparation (OAMBP (1 day method: 1 pack of PEG based solution the day before surgery, or 2 days method: 1 pack of PEG based solution two days before surgery)) in the incidence of postoperative complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of SSI
Key secondary outcomes
Incidence of postoperative complications excluded SSI, operation time, extent of bleeding, postoperative hospital stay, intraoperative adverse events, degree of patient burden, degree of intraoperative intestinal dilation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mOAMBP group(sodium picosulfate hydrate + Kanamycin, Metronidazole)
(combined drug)
Kanamycin 250mg 12C x3(after lunch, dinner, and before bedtime) and Metronidazole 250mg 6C x3(after lunch, dinner, and before bedtime) per oral the day before surgery
(research drug)
(1 day method) sodium picosulfate hydrate 75.0mg(after hospitalization) per oral
or
(2 days method) sodium picosulfate hydrate 37.5 mg two days before surgery(after hospitalization) and 37.5 mg the day before surgery(morning) per oral
Interventions/Control_2
OAMBP group(PEG/PEG based solution + Kanamycin, Metronidazole)
(combined drug)
Kanamycin 250mg 12C x3(after lunch, dinner, and before bedtime) and Metronidazole 250mg 6C x3(after lunch, dinner, and before bedtime) per oral the day before surgery
(control drug)
(1 day method) 1 pack of PEG/ PEG based solution the day before surgery(after hospitalization) per oral
(2 days method) 1 pack of PEG/ PEG based solution two days before surgery(after hospitalization) per oral
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) Patients undergoing resection for rectal cancer or left-sided colon cancer, with or without diverting ileostomy
2) Patients undergoing DST or transanal bowel anastomosis
3) Patients between 20 and 85 years old
4) Patients with a performance status (ECOG) of 0 or 1
5) Patients who meet the following criteria for laboratory tests within 30 days of enrollment
1. White blood cell: WBC = 3000, or 3000<WBC<10000/ul
2. Neutrophils: Neu = 1500, Neu > 1500/ul
3. Hemoglobin: Hb = 9.0 or > 9.0g/dl
4. Platelet: Plt = 70000 or > 70000/ul
5. Total Bilirubin: T.Bil = 1.5 or < 1.5mg/dl
6. AST: AST = 100 or < 100IU/l
7. ALT: ALT = 100 or < 100IU/l
8. Albumin: Alb = 2.5 or > 2.5g/dl
6) Patients who have given informed consent
Key exclusion criteria
1) Patients who need emergency surgery
2) Patients with preoperative intestinal obstruction
3) Patients with suspected active bacterial infection (abscess formation, colon cancer perforation, etc.)
4) Patients who are pregnant or have the potential to become pregnant
5) Diabetic patients with poor control (HbA1c 8.0 or < 8.0)
6) Patients who are allergic to drugs used in the study (macrogol, sodium picosulfate hydrate, kanamycin, metronidazole)
7) Patients undergoing neoadjuvant radiotherapy or neoadjuvant chemotherapy
8) Patients with colostomy or ileostomy
9) Patients who have not given informed consent
10) Patients who are judged by the principal investigator or the investigator to be ineligible for the safe conduct of this study
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Tokyo Medical and Dental University Graduate School of Medicine
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5254
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Sodai |
| Middle name | |
| Last name | Arai |
Organization
Tokyo Medical and Dental University Graduate School of Medicine
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-5803-5254
Homepage URL
sarai.srg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Graduate School of Medicine
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
Tokyo Medical and Dental University Ethics Review Committee
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-6111
syomu1.adm@tmd.ac.jp
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
東京医科歯科大学医学部付属病院（東京都）、江戸川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 28 | 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
119
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
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049265
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/10/17 | 研究計画書 4版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
