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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042658
Receipt No. 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

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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
Email 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
Email nanksrg1@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Department of Gastrointestinal Surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048675

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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