UMIN-CTR Clinical Trial

Basic information
Public title	Prerehabilitation for elderly patients undergoing gastrointestinal surgery
Acronym	Prerehabilitation for elderly patients undergoing gastrointestinal surgery
Scientific Title	Prerehabilitation for elderly patients undergoing gastrointestinal surgery
Scientific Title:Acronym	Prerehabilitation for elderly patients undergoing gastrointestinal surgery
Region	Japan

Condition
Condition	gastrointestinal cancer
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In recent years, the number of gastrointestinal cancer surgeries performed on the elderly over the age of 75 has been on the rise due to the aging of the population. Many elderly patients have co-morbidities, physical function is impaired, and a high percentage of them are frail. Perioperative management for the elderly should aim for early postoperative recovery and early return to society as much as possible. However, the elderly have physical functional decline even before surgery, which is further impaired by the invasive nature of surgery, so postoperative rehabilitation alone is not sufficient. Therefore, preoperative rehabilitation intervention is desirable. The effects of preoperative rehabilitation intervention on gastrointestinal cancer patients have been reported to improve physical function before and after surgery and to promote early recovery after surgery Therefore, the purpose of this study was to examine the effects of preoperative rehabilitation on prevention of postoperative complications and early postoperative recovery in elderly patients undergoing gastrointestinal cancer surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SPPB score
Key secondary outcomes	Postoperative complications, postoperative days in the hospital, postoperative independence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Preoperative rehabilitation
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	75 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Adult patients who are 75 years of age or older (age at admission) at the time of obtaining consent 2) Patients indicated for surgery under general anesthesia for gastrointestinal cancer (iii) Gender: Any gender (4) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria	(1) Patients with psychiatric complications that would make it difficult for them to participate in the study. 2) Bone and joint diseases that may affect upper and lower limb muscle strength. (iii) Complicated cerebrovascular disease (those with obvious neurological abnormalities: sensory disturbance or motor paralysis) (iv) Other patients deemed inappropriate as subjects by the principal investigator.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Matsumoto
Organization	Nagasaki University Hospital
Division name	Departmnet of Surgery
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki City
TEL	0958197316
Email	r-matsumoto@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Matsumoto
Organization	Nagasaki University Hospital
Division name	Departmnet of Surgery
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki City
TEL	0958197316
Homepage URL
Email	r-matsumoto@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
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	Nagasaki University Hospital
Address	1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel	095-819-7229
Email	gaibushikin@ml.nagasaki-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	2022 Year 12 Month 25 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	2022 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date	2023 Year 01 Month 01 Day
Last follow-up date	2027 Year 12 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	2022 Year 11 Month 27 Day
Last modified on	2022 Year 11 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056487