Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00564

2 Trial Registration Date

2017-09-07

i Registration Status

Prospective

3 Secondary IDs

2017.363-T

4 Source(s) of Funding

none

5 Primary Sponsor

LIU Yunhong

6 Secondary Sponsor

Carmen W.H. Chan

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

LIU Yunhong

ii Address

Rm601, Esther Lee Building, CUHK, Shatin, N.T., Hong Kong

iii Phone

+852 39433517

iv Email

liuyunhong@link.cuhk.edu.hk

v Affiliation

the Chinese University of Hong Kong

vi Country

P.R. China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Yunhong Liu

ii Address

Rm601, Esther Lee Building, CUHK, Shatin, N.T., Hong Kong

iii Phone

+852 39433517

iv Email

liuyunhong@link.cuhk.edu.hk

v Affiliation

the Nethersole School of Nursng, the Chinese University of Hong Kong

vi Country

the People's Republic of China

9 Official Scientific Title of the Study

Evaluation the effectiveness of acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer: a mixed-method study

10 Public Title

Evaluation the effectiveness of acupressure on postoperative gastrointestinal function in patients undergoing surgery for colorectal cancer: a mixed-method study

i Public Title in Chinese 研究名稱

按摩对结直肠手术后肠功能恢复的研究; 按摩的过程评价─质性研究

11 Short Title (Optional)

12 Countries of Recruitment

P.R.China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-08-05

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.363-T

14 Medical Condition Being Studied

colorectal cancer

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

acupressure

iii Dosage form of the intervention

acupressure by acupen

iv Dosage of the intervention

The acupressure process will be repeated by pressing ten seconds (one pressing per second) then resting two seconds for a total of 12 seconds per sequence.

v Duration of the intervention

The duration of acupressure will be until the fifth day after surgery since five days are reckoned a

vi Frequency of the intervention

The whole process will repeat 50 times lasting for ten minutes, with 25 times lasting for five minut

16 Comparative Treatments

i Description/ name of comparative treatments

sham acupressure

ii Dosage form of the comparative treatments

acupressure by acupen

iii Dosage of the comparative treatments

The acupressure process will be repeated by pressing ten seconds (one pressing per second) then resting two seconds for a total of 12 seconds per sequence.

iv Duration of the comparative treatments

The duration of acupressure will be until the fifth day after surgery since five days are reckoned a

v Frequency of the comparative treatments

The whole process will repeat 50 times lasting for ten minutes, with 25 times lasting for five minut

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult patients (≥ 18 years) who are scheduled to receive colorectal cancer surgery will be eligible for this study. Consecutive participants with their written consents will be included.

ii Exclusion Criteria

i. patients are unable to communicate due to language barrier or severe cognitive impairment;

ii. patients with skin infections or defects in lower limbs which will hinder the accuracy of locating ST36 or get infection worse;

iii. patients are scheduled to have more than one surgery during this hospitalization;

iv. patients with coagulation disorders or peripheral vascular disease or having signs of compromised circulation in lower limbs.

iii Age Minimum

18

iv Age Maximum

100

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized controlled trial

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

This is not a drug study.

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-10-09

21 Target Sample Size

78

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

the first passage of flatus and defecation

ii The metric or method of measurement used

observation

iii The timepoint(s) of primary interest

within five days after surgery

24 Secondary Outcome

i The Name of the outcome

the time to oral food intake, the incidence of postoperative nausea and vomiting (PONV), the need for antiemetic drugs, the degree of abdominal distention and pain and the length of hospital stay; Explore patients’ acceptability, perceived benefits and limitations of acupressure

ii The metric or method of measurement used

observation, clinical assessment by stethoscope and individual interviews

iii The timepoint(s) of primary interest

within five days after surgery and during hospitalization

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-09-18

27 Primary Registry and Trial Identifying Number

ChiCTR-IIC-17012633

28 Date of Registration in Primary Registry

2017-09-07

Back History

Trial Detail