UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032635
Receipt No. 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 2018/05/18

* 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
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Surgical Oncology/Division of Gastrointestinal Surgery, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 0527442222
Email yyoko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Surgical Oncology/Division of Gastrointestinal Surgery, Department of Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 0527442222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Division of Surgical Oncology/Division of Gastrointestinal Surgery, Department of Surgery
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
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
2018 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.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


Contact us.