UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040653 |
|---|---|
| Receipt number | R000046402 |
| Scientific Title | Evaluation of usefulness of transumbilical incision for laparoscopic surgery |
| Date of disclosure of the study information | 2020/06/05 |
| Last modified on | 2020/06/04 17:08:16 |
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Basic information
Public title
Evaluation of usefulness of transumbilical incision for laparoscopic surgery
Acronym
Evaluation of usefulness of transumbilical incision
Scientific Title
Evaluation of usefulness of transumbilical incision for laparoscopic surgery
Scientific Title:Acronym
Evaluation of usefulness of transumbilical incision
Region
| Japan |
Condition
Condition
Cases of laparoscopic surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the advantages, complications, and risk factors of transumbilical incisions for organ removal in laparoscopic abdominal hepatobiliary-pancreatic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated SSI and wound disruption as short-term complications, and umbilical port site hernia as a long-term complication. SSIs were monitored by the infection control team in our hospital, and umbilical port site hernias were routinely assessed by follow-up computed tomography (CT). We also evaluated the risk factors for short- and long-term complications.
Key secondary outcomes
Base
Study type
Observational
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
| 25 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients who underwent hepatobiliary-pancreatic laparoscopic surgery at Showa university hospital.
Key exclusion criteria
The patients with follow-up in other hospitals from the early postoperative period, those without organ removal from the transumbilical wound, those converted to laparotomy, and those undergoing multiple simultaneous procedures.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kodai |
| Middle name | |
| Last name | Tomioka |
Organization
Showa University hospital
Division name
Gastroenterological and general surgery
Zip code
142-8666
Address
1-5-8 Hatanodai Shinagawa Tokyo
TEL
03-3784-8541
tomioka@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | |
| Last name | Tomioka |
Organization
Showa University hospital
Division name
Gastroenterological and general surgery
Zip code
142-8666
Address
1-5-8 Hatanodai Shinagawa Tokyo
TEL
03-3784-8541
Homepage URL
tomioka@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University
Address
1-5-8 Hatanodai Shinagawa Tokyo
Tel
03-3784-8541
tomioka@med.showa-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
| 2020 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study.
Patients between January 2013 and December 2019.
Management information
Registered date
| 2020 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046402
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
