UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053024 |
|---|---|
| Receipt number | R000060487 |
| Scientific Title | A Randomized Controlled Trial of Postoperative Abdominal Drain Placement in Minimally Invasive Liver Surgery |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2023/12/06 22:16:03 |
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Basic information
Public title
A Randomized Controlled Trial of Postoperative Abdominal Drain Placement in Minimally Invasive Liver Surgery
Acronym
MIS-Do Trial
Scientific Title
A Randomized Controlled Trial of Postoperative Abdominal Drain Placement in Minimally Invasive Liver Surgery
Scientific Title:Acronym
MIS-Do Trial
Region
| Japan |
Condition
Condition
Primary or metastatic liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness and safety of non-implantation of a postoperative intraperitoneal drain in minimally invasive liver surgery (laparoscopic or robot-assisted laparoscopic hepatectomy).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Clavien-Dindo grade II or higher complications resulting from hepatectomy
Key secondary outcomes
Postoperative days in hospital, bile leakage rate, postoperative bleeding, right chest fluid retention, invasive infection rate, postoperative total comorbidity rate, and mortality rate related to the surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Postoperative intraperitoneal drain not placed
Interventions/Control_2
Postoperative intraperitoneal drain placed
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing laparoscopic or robotic partial hepatectomy(S2/S3/S4/S5/S6), segmentectomy (S3/S5/S6) or LLS
Key exclusion criteria
(1) Patients who will undergo a complicated resection of other organs
(2) Patients with serious comorbidities, etc.
(3) Persons who did not agree to participate in the study after receiving a full explanation of the study
(4) Other persons who are deemed inappropriate by the investigator.
Target sample size
182
Research contact person
Name of lead principal investigator
| 1st name | Tomoharu |
| Middle name | |
| Last name | Yoshizumi |
Organization
Kyushu University Hospital
Division name
Department of Surgery and Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashiku, Fukuoka, Japan
TEL
0926425466
yoshizumi.tomoharu.717@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Yoshiya |
Organization
Kyushu University Hospital
Division name
Department of Surgery and Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashiku, Fukuoka, Japan
TEL
0926425466
Homepage URL
https://surg2.kyushu-u.ac.jp
yoshiya.shohei.064@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards / Ethics Committees of Kyushu University Hospital and Medical Institutions
Address
3-1-1, Maidashi, Higashiku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060487
