UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032635 |
|---|---|
| Receipt number | R000037216 |
| Scientific Title | The impact of Synbiotic and Prehabilitation Therapy on the postoperative outcome in patients undergoing highly invasive surgery. A randomized controlled study. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/05/20 10:01:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The impact of Synbiotic and Prehabilitation Therapy on the postoperative outcome in patients undergoing highly invasive surgery. A randomized controlled study.
Acronym
The impact of Synbiotic and Prehabilitation Therapy on the postoperative outcome in patients undergoing highly invasive surgery.
Scientific Title
The impact of Synbiotic and Prehabilitation Therapy on the postoperative outcome in patients undergoing highly invasive surgery. A randomized controlled study.
Scientific Title:Acronym
The impact of Synbiotic and Prehabilitation Therapy on the postoperative outcome in patients undergoing highly invasive surgery.
Region
| Japan |
Condition
Condition
Patients who are going to undergo a highly invasive abdominal surgery.
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To invastigate an impact of synbiotics/prehabilitation therapy in patients undergoing a highly invasive abdominal surgery, with special interest for the intestinal microenvironment, muscle mass, functional exercise capacity, and short and long term outcomes after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.To compare the nutritional status, host immune function, intestinal microbitota, fecal organic acids concentrations, muscle mass, fat mass, and exercise capacity between Synbiotics group and Synbio-Prehabilitation group.
2.To Compare the incidence of postoperative complications and the length of postoperative hospital stay.
3.To investigate the correlation between the preoperative conditions including nutritional status, host immune function, intestinal microbiota, fecal organic acids concentrations, muscle mass, fat mass, and functional exercise capacity and the incidence of postoperative complications and the length of postoperative hospital stay.
Key secondary outcomes
4.To compare the long term outcome after surgery between Synbiotics and Synbio-Prehabilitation groups.
5.To investigate the impact of preoperative nutritional status, host immune function, intestinal microbiota, fecal organic acids, muscle mass, fat mass, and functional exercise capacity on the long term outcome after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Synbiotics therapy
Interventions/Control_2
Synbio-Prehabilitation therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are going to undergo a highly invasive surgery in Nagoya University Hospital Surgery I and II.
Highly invasive surgery includes;
1. Major hepatectomy
2. Hepatopancreatoduodenectomy
3. Pancreatoduodenectomy
4. Destal pancreatectomy with celiac axis resection
5. Other highly invasive surgeries with similar invasion as above procedures
Key exclusion criteria
Patients who rejected to participate this study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yokoyama |
| Middle name | |
| Last name | Yukihiro |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology/Division of Gastrointestinal Surgery, Department of Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442222
yyoko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yokoyama |
| Middle name | |
| Last name | Yukihiro |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology/Division of Gastrointestinal Surgery, Department of Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Division of Surgical Oncology/Division of Gastrointestinal Surgery, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine, Division of Surgical Oncology/Division of Gastrointestinal Surgery, Department of Surgery
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
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
0527442218
ethics@med.nagoya-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
| 2018 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 18 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037216
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
