UMIN-ICDS Clinical Trial

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

gastrointestinal cancer

Classification by specialty

Surgery in general

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

SPPB score

Key secondary outcomes

Postoperative complications, postoperative days in the hospital, postoperative independence

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagasaki University

Institute

Department

Personal name

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2022

Year

11

Month

27

Day

Last modified on

2022

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056487