UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057585 |
|---|---|
| Receipt number | R000065785 |
| Scientific Title | Research on the effectiveness of wound protection in robot-assisted surgery |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2026/03/09 23:40:54 |
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Basic information
Public title
Research on the effectiveness of wound protection in robot-assisted surgery
Acronym
Research on the effectiveness of wound protection in robot-assisted surgery
Scientific Title
Research on the effectiveness of wound protection in robot-assisted surgery
Scientific Title:Acronym
Research on the effectiveness of wound protection in robot-assisted surgery
Region
| Japan |
Condition
Condition
Robot-assisted lobectomy or equivalent surgery
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the usefulness of using a lap protector (Mini Mini) during robot-assisted surgery to prevent lens contamination and reduce the number of times the lens needs to be cleaned.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of reducing the number of lens cleaning procedures during surgery
Key secondary outcomes
Improvement in surgery time, improvement in wound crush, improvement in pain, stress reduction effect for staff involved during surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
This is a study to evaluate whether the use of additional lap protectors MiniMIni, which are used in ordinary endoscopic surgery, enables surgeons to perform surgery smoothly and safely. In other words, this is an appropriate use of medical devices, and the main purpose is not to evaluate the efficacy and safety of new medical devices.
Interventions/Control_2
The control group will be the group that does not use the wrap protector (Mini Mini).
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
Preoperative
1. The patient is scheduled to undergo robot-assisted lobectomy or a similar procedure.
2. The patient is between 20 and 85 years old on the day of surgery.
3. ASA 1-2
4. Plt >=100,000, Cr<=2.0mg/dl
5. The patient has given written consent.
During surgery
The patient has undergone lobectomy (with lymph node dissection) or a similar procedure.
Key exclusion criteria
1. Patients who have had a previous thoracotomy on the same side as the planned surgery due to a thoracic disease. 1. Patients with a history of tuberculosis or other conditions that may result in thoracic adhesions. 2. Patients with severe interstitial pneumonia, pulmonary fibrosis, or emphysema. 3. Patients with cirrhosis or renal failure. 4. Patients with a history of radiation therapy to the chest wall or thoracic cavity. 5. Patients with a history of allergy to local anesthetics or narcotics. 6. Pregnant or possibly pregnant. 7. Patients with psychosis or psychiatric symptoms that make it difficult to participate in the study. 8. Patients with active infection, serious cardiac complications, or poorly controlled diabetes.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Rei |
| Middle name | |
| Last name | Kobayashi |
Organization
Itabashi Chuo Medical Center
Division name
Department of Thoracic Surgery
Zip code
174-0051
Address
2-12-7, Azusawa, Itabashi-ku, Tokyo 174-0051, Japan
TEL
03-3967-1181
chinosenar@gmail.com
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Kobayashi |
Organization
Itabashi Chuo Medical Center
Division name
Department of Thoracic Surgery
Zip code
174-0051
Address
2-12-7, Azusawa, Itabashi-ku, Tokyo 174-0051, Japan
TEL
03-3967-1181
Homepage URL
chinosenar@gmail.com
Sponsor or person
Institute
Itabashi Chuo Medical Center
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
Clinical Research Ethics Committee
Address
2-12-7, Azusawa, Itabashi-ku, Tokyo 174-0051, Japan
Tel
03-3967-1181
komayasu@gunma-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
| 2025 | Year | 04 | Month | 11 | 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
| 2025 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 04 | 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
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065785
