UMIN-CTR Clinical Trial

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
Email	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
Email	yyoko@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023985