UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029604 |
|---|---|
| Receipt number | R000033824 |
| Scientific Title | Standardization of surgical procedures for laparoscopic Spiegel lobe resection: a single institutional experience |
| Date of disclosure of the study information | 2017/10/18 |
| Last modified on | 2017/10/18 00:21:05 |
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Basic information
Public title
Standardization of surgical procedures for laparoscopic Spiegel lobe resection: a single institutional experience
Acronym
Standardization for laparoscopic Spiegel lobectomy
Scientific Title
Standardization of surgical procedures for laparoscopic Spiegel lobe resection: a single institutional experience
Scientific Title:Acronym
Standardization for laparoscopic Spiegel lobectomy
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma (HCC)
Colorectal liver metastasis (CRLM)
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We applied our surgical procedures to laparoscopic Spiegel lobectomy and retrospectively compared the perioperative outcomes between laparoscopic and open procedures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative blood loss
Key secondary outcomes
Age/Sex/height/weight/BMI(body mass index)/Diagnosis(HCC or CRLM)/Child-Pugh score/Greater diameter of the tumor/Number of tumors/Past history of abdominal surgery/Operation time/RBC transfusion/Surgical margin
(positive/negative)/Length of hospital stay/Postoperative complications
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent Spiegel lobe resection between 2007 and 2017 at Wakayama Medical University Hospital
Key exclusion criteria
1)Patients who refused the entry to this study
2)others
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Ueno |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama-city, Japan
TEL
073-441-0613
ma@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Hayami |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama-city, Japan
TEL
073-441-0613
Homepage URL
shin-8@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical 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
Address
Tel
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
| 2017 | Year | 10 | Month | 18 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2017 | Year | 10 | Month | 18 | Day |
Last modified on
| 2017 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033824
