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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038791
Receipt No. R000044226
Scientific Title The impact of Goal-Directed Prehabilitation Therapy on the functional capacity in patients undergoing highly invasive surgery.
Date of disclosure of the study information 2019/12/04
Last modified on 2019/12/04

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Basic information
Public title The impact of Goal-Directed Prehabilitation Therapy on the functional capacity in patients undergoing highly invasive surgery. A randomized controlled study
Acronym The impact of Goal-Directed Prehabilitation Therapy on the functional capacity in patients undergoing highly invasive surgery.
Scientific Title The impact of Goal-Directed Prehabilitation Therapy on the functional capacity in patients undergoing highly invasive surgery.
Scientific Title:Acronym The impact of Goal-Directed Prehabilitation Therapy on the functional capacity in patients undergoing highly invasive surgery.
Region
Japan

Condition
Condition Patients who are going to undergo a highly invasive abdominal surgery.
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To invastigate an impact of conventional prehabilitation therapy/goal-directed 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 To compare the nutritional status, host immune function, intestinal microbitota, fecal organic acids concentrations, muscle mass, fat mass, and exercise capacity between conventional prehabilitation group and goal-directed prehabilitation group.
Key secondary outcomes 1. To Compare the incidence of postoperative complications and the length of postoperative hospital stay.
2.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.
3.To compare the long term outcome after surgery between Synbiotics and Synbio-Prehabilitation groups.
4.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 Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Goal-directed prehabilitation therapy
Interventions/Control_2 Conventional 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.
who can not do exercise.
who has a congenital metabolic disorder for the branched chain amino acids.
who undergo emergent surgery.
who are with severe complications.
who are with mental disorder.
who are with cognitive disorder.
who have a risk of fall.
who are not eligible for the study determined by the investigators.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Yukihiro
Middle name
Last name Yokoyama
Organization Nagoya University Graduate School of Medicine
Division name Division of Gastrointestinal Surgery, Department of Surgery
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan 4668550
TEL 0527442222
Email yyoko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Yokoyama
Organization Nagoya Unviersity Graduate School of Medicine
Division name Division of Gastrointestinal Surgery, Department of Surgery
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

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

Funding Source
Organization Nagoya University Graduate School of Medicine, Division of Gastrointestinal Surgery, Department of Surgery
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 Nagoya University Ethics Committee
Address 65 Tsurumai-cho, Showa-ku, Aichi, Japan
Tel 052-744-2479
Email 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
2019 Year 12 Month 04 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 10 Month 01 Day
Anticipated trial start date
2019 Year 12 Month 04 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 12 Month 04 Day
Last modified on
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044226

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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