UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020780 |
|---|---|
| Receipt number | R000023985 |
| Scientific Title | The investigation for the impact of preoperative physical and nutritional support on the muscle strength and muscle mass, and the incidence of postoperative complications following highly invasive surgeries. |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2021/08/02 11:16:39 |
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Basic information
Public title
The investigation for the impact of preoperative physical and nutritional support on the muscle strength and muscle mass, and the incidence of postoperative complications following highly invasive surgeries.
Acronym
The impact of preoperative physical and nutritional support
Scientific Title
The investigation for the impact of preoperative physical and nutritional support on the muscle strength and muscle mass, and the incidence of postoperative complications following highly invasive surgeries.
Scientific Title:Acronym
The impact of preoperative physical and nutritional support
Region
| Japan |
Condition
Condition
Patients who are going to undergo major hepatectomy, pancreatoduodenectomy, subtotal esophagectomy, or total pelvic exenteration for cancer.
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Operative medicine |
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether preoperative physical and nutritional support increase the muscle mass and muscle strength in patients who are going to undergo highly invasive surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The impact of preoperative physical and nutritional therapy on the alternation of muscle mass, muscle strength, and functional capacity. Compare the data before and after (immediately before surgery, approximately 1.5 months after initiating therapy ) the induction of preoperative physical and nutritional therapy.
2. Difference in the incidence of postoperative complications (occurred within 1 month after surgery) between patients with preoperative physical and nutritional therapy and those without (case control study).
Key secondary outcomes
1. The correlation between the preoperative muscle mass and muscle strength and the incidence of postoperative complications (occurred within 1 month after surgery).
2. The correlation between the muscle mass or muscle strength loss during the acute phase after surgery and the incidence of postoperative complications(occurred within 1 month after surgery).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Preoperative physical therapy
Warming up, walking (30 min), resistance training (20 min), and cool down. Three to 7 times in a week.
Nutritional therapy
Oral intake of essential amino acids supplement with high content of leucine (Amino L 40). Two bottles per day.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age equal to and over 20 years-old. Both gender.
2. Patients who are going to undergo either major hepatectomy, pancreatoduodenectomy, subtotal esophagectomy, or total pelvic exenteration for cancer.
3. Patients who agreed to participate in this study.
Key exclusion criteria
1.Patients who are unable to do physical training.
2. Patients with metabolic dysfunction for amino acids.
3. Patients who are allergic to apple (because Amino L40 contains apple flavor).
4. A patient who by him-/herself or his/her family rejected to participate in this study.
5. A case of emergent surgery.
6. Patients with severe complications (heart disease, pulmonary disease, renal disease, hepatic disease, etc.).
7. Patients with severe mental dysfunction.
8. Patients with severe cognitive disorder.
9. Patients who were determined inappropriate to participate in this study by attending physician.
Target sample size
80
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, Department of Surgery,
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442218
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yokoyama |
| Middle name | |
| Last name | Yukihiro |
Organization
Nagoya University Hospital
Division name
Surgery 1
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine
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
052-744-2479
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
| 2016 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
156
Results
After the introduction of prehabilitation program, muscle mass has increased, exercise capacity has improved, and postoperative hospital stay was shortened.
Results date posted
| 2021 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who are going to undergo major hepato-pancreato-biliary surgery for malignancy.
Participant flow
After informed consent, patients were guided to do prehabilitation.
Adverse events
None
Outcome measures
Changes of muscle mass, body fat, and exercise capacity, after the introduction of prehabilitation. Compare the postoperative complications and postoperative hospital stay with historical control using propensity score matching.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 02 | 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
| 2016 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023985
