UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058605 |
|---|---|
| Receipt number | R000067011 |
| Scientific Title | Assessing the Clinical Usefulness of Laparoscopic Surgery Trials: A Systematic Review |
| Date of disclosure of the study information | 2025/07/26 |
| Last modified on | 2025/07/26 08:46:29 |
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Basic information
Public title
Bridging Evidence in Practice: A Systematic Review of Usefulness in Randomized Controlled Trials of Laparoscopic Techniques in General Surgery (2020-2024)
Acronym
Bridging Evidence in Practice: A Systematic Review of Usefulness in Randomized Controlled Trials of Laparoscopic Techniques in General Surgery (2020-2024)
Scientific Title
Assessing the Clinical Usefulness of Laparoscopic Surgery Trials: A Systematic Review
Scientific Title:Acronym
Assessing the Clinical Usefulness of Laparoscopic Surgery Trials: A Systematic Review
Region
| North America |
Condition
Condition
Laparoscopic Techniques within the Scope of General Surgery
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness and transparency of general surgery RCTs on laparoscopic procedures published 2020-2024 using the van 't Hooft framework.
Basic objectives2
Others
Basic objectives -Others
Systematic review of trial design quality and applicability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of clinical utility and transparency scores of included RCTs, as measured by a 13-item framework.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
RCTs focused on laparoscopic procedures in general surgery, published 2020-2024, in English, with human participants aged 18 years or older.
Key exclusion criteria
Non-RCTs, single-group studies, pharmacologic-only trials, non-general surgery, pediatric, gynecologic, or urologic procedures, studies without English full text.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Lauren |
| Middle name | Elizabeth |
| Last name | Kocour |
Organization
Oklahoma State University Center for Health Sciences
Division name
Office of Medical Student Research
Zip code
74107
Address
1111 W 17th St., Tulsa, OK 74107, USA
TEL
918-582-1972
lkocour.osu@gmail.com
Public contact
Name of contact person
| 1st name | Lauren |
| Middle name | Elizabeth |
| Last name | Kocour |
Organization
Oklahoma State University Center for Health Sciences
Division name
Office of Medical Student Research
Zip code
74107
Address
1111 W 17th St., Tulsa, OK 74107, USA
TEL
918-582-1972
Homepage URL
lkocour.osu@gmail.com
Sponsor or person
Institute
None.
Institute
Department
Personal name
Funding Source
Organization
Self-funded (no external funding)
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
Oklahoma State University Center for Health Sciences
Address
1111 W 17th St., Tulsa, OK 74107, USA
Tel
19185821972
chsirb@okstate.edu
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 | 07 | Month | 26 | 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
160
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
| 2025 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study employed a systematic review of randomized controlled trials evaluating laparoscopic interventions in general surgery, published between 2020 and 2024. Clinical usefulness was assessed using a modified van 't Hooft framework, which evaluates elements such as generalizability, clinical relevance, and implementation potential. Two reviewers independently screened studies and extracted data in duplicate, with discrepancies resolved through consensus. Descriptive statistics and summary metrics were used to evaluate the usefulness domains across included trials.
Management information
Registered date
| 2025 | Year | 07 | Month | 26 | Day |
Last modified on
| 2025 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067011
