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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040653
Receipt No. 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

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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
Email 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
Email tomioka@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046402

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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