UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002547 |
|---|---|
| Receipt number | R000003113 |
| Scientific Title | Laparoscopy-assisted distal gastrectomy versus open distal gastrectomy. A prospective randomized single-blind study |
| Date of disclosure of the study information | 2009/09/25 |
| Last modified on | 2009/09/25 16:54:35 |
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Basic information
Public title
Laparoscopy-assisted distal gastrectomy versus open distal gastrectomy. A prospective randomized single-blind study
Acronym
LADG vs. Open distal gastrectomy- randomized single-blind trial
Scientific Title
Laparoscopy-assisted distal gastrectomy versus open distal gastrectomy. A prospective randomized single-blind study
Scientific Title:Acronym
LADG vs. Open distal gastrectomy- randomized single-blind trial
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate differences in postoperative physical activity between laparoscopy assisted distal gastrectomy (LADG) and open distal gastrectomy (ODG).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of the study was comparison of physical activity between the LADG and ODG groups using Active tracer.
Key secondary outcomes
The secondary endpoints were various postoperative surgical parameters, duration of pain control, times of pain rescue and visual analog pain scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
open distal gastrectomy (ODG)
Interventions/Control_2
laparoscopy assisted distal gastrectomy (LADG)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were age between 20 and 80 years, performance status of ECOG 0-1, signed informed consent, location of the primary tumor in the antrum, angle and lower body, histologically confirmed adenocarcinoma of the stomach with preoperative staging of stage IA or IB
Key exclusion criteria
The exclusion criteria were metastatic disease, previous history of malignancy in any organ, any co-morbidity obviating major surgery, contraindication to laparoscopy such as severe cardiac disease, abdominal wall hernias, portal hypertension, pregnancy, previous upper abdominal major surgery excluding appendectomy and laparoscopic cholecystectomy, complicated cases requiring emergency surgery, and an accompanying surgical condition requiring surgery at the same time.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Takiguchi |
Organization
Graduate School of Medicine, Osaka University
Division name
Division of Gastroenterological Surgery
Zip code
Address
2-2 E2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Osaka University
Division name
Division of Gastroenterological Surgery
Zip code
Address
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Division of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2009 | Year | 09 | Month | 25 | 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
| 2002 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 25 | Day |
Last modified on
| 2009 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003113
| Research Plan | |
|---|---|
| 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 |
