UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042658 |
|---|---|
| Receipt number | R000048675 |
| Scientific Title | The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study |
| Date of disclosure of the study information | 2021/01/04 |
| Last modified on | 2020/12/04 22:32:39 |
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Basic information
Public title
The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study
Acronym
The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study
Scientific Title
The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study
Scientific Title:Acronym
The efficacy of prophylactic Sulbactam/Ampicillin in the treatment of perineal wound infection after abdominoperineal resection. Multicenter randomized controlled study
Region
| Japan |
Condition
Condition
Rectal cancer, Anal canal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to validate "the superiority of the study treatment Sulbactam/Ampicillin for 4 days postoperatively over the standard treatment Cefmetazole for up to 24 hours postoperatively for the prevention of perineal wound infection after abdominoperineal resection" by randomized comparison.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of perineal wound infection within 30 days after surgery
Key secondary outcomes
1 Incidence of all SSI(surgical site infection)
2 Percentage of all complications, excluding SSI, within 30 days of surgery.
3 Methicillin-resistant Staphylococcus Aureus (MRSA) detection rate
4 Post-operative hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Sulbactam/Ampicillin (SBT/AMPC)
Interventions/Control_2
Cefmetazole (CMZ)
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
Patients for whom abdominoperineal resection (APR) is the planned procedure for rectal cancer and anal canal cancer
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-2
Patients who are between 20 and 85 years of age at the time of obtaining consent
Patients who have been fully informed and understandably given their voluntary written consent to participate in this study
major organ functions are preserved on clinical examination within 30 days of enrollment
Key exclusion criteria
Patients who meet any of the following conditions are not eligible
(1) Patients with previous hypersensitivity to SBT/ABPC or CMZ
(2) Emergency surgery
(3) Patients with poorly controlled diabetes (HbA1c over 8.0), chronic renal failure requiring dialysis, and patients requiring immunosuppressive drugs
(4) Patients with a systemic active infection or fever (>38 degrees Celsius) and suspected infection
(5) Patients who are either pregnant, likely to be pregnant, within 28 days after delivery, or breastfeeding
(6) Serious organ failure
(7) As a result of preoperative explanations, cases of disagreement
(8) Any other patient whom the principal investigator or the researcher determines to be unsuitable for the safe conduct of the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kinugasa |
Organization
Tokyo Medical and Dental University
Division name
Gastrointestinal Surgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyoku, Tokyoto
TEL
03-5803-6111
kinugasa.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akitoshi |
| Middle name | |
| Last name | Nankaku |
Organization
Tokyo Medical and Dental University
Division name
Gastrointestinal Surgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyoku, Tokyoto
TEL
03-5803-6111
Homepage URL
nanksrg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Gastrointestinal 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
Tokyo Medical and Dental University Ethics Review Committee
Address
1-5-45, Yushima, Bunkyoku, Tokyoto
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
静岡県立静岡がんセンター(静岡県)、武蔵野赤十字病院（東京都）、静岡県立総合病院（静岡県）、国立がん研究センター中央病院（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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048675
| Research Plan | |
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| Registered date | File name |
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