Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00566

2 Trial Registration Date

2017-09-07

i Registration Status

Prospective

3 Secondary IDs

2017.318

4 Source(s) of Funding

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

Department of Surgery, The Chinese University of Hong Kong

Function

Not Applicable

Please specify

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

i Name

Mr Freddie Chiu

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

iii Phone

35052735

iv Email

freddie@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Cindy Tsui

ii Address

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

iii Phone

35052735

iv Email

cindytsui@gmail.com

v Affiliation

Department of Anaesthesia and Intensive Care, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Feasibility and Safety of Early Recovery After Surgery (ERAS) Protocol in Patient Undergoing Laparoscopic Bariatric Surgeries

10 Public Title

Feasibility and Safety of Early Recovery After Surgery (ERAS) Protocol in Patient Undergoing Laparoscopic Bariatric Surgeries

i Public Title in Chinese 研究名稱

術後早期恢復方案在腹腔鏡肥胖症手術患者中的可行性和安全性

11 Short Title (Optional)

Early recovery after surgery for obesity

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-07-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.318

14 Medical Condition Being Studied

early recovery

bariatric surgery

obesity

15 Intervention

i Types of intervention

Other

Please specify

Not Applicable

ii Description/ name of Intervention/article

Not Applicable

iii Dosage form of the intervention

Not Applicable

iv Dosage of the intervention

Not Applicable

v Duration of the intervention

Not Applicable

vi Frequency of the intervention

Not Applicable

16 Comparative Treatments

i Description/ name of comparative treatments

Not Applicable

ii Dosage form of the comparative treatments

Not Applicable

iii Dosage of the comparative treatments

Not Applicable

iv Duration of the comparative treatments

Not Applicable

v Frequency of the comparative treatments

Not Applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adults undergoing laparoscopic bariatric surgery including sleeve gastrectomy, gastric banding, gastric plication and gastric bypass (Roux-en Y gastric bypass (RYGB) or duodeno-jejunal bypass (DJB)).

ii Exclusion Criteria

less than 18 years of age

history of drug abuse, opioid dependence or chronic pain

iii Age Minimum

18

iv Age Maximum

100

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

Not Applicable

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-09-14

21 Target Sample Size

60

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

The primary outcome to assess feasibility of bariatric ERAS program will be measuring the compliance rate.

ii The metric or method of measurement used

The overall compliance rate and compliance rate for each ERAS element will be recorded.

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

Secondary outcomes include length of hospital stay and time to discharge from post anaesthesia care unit. We will also measure the postoperative hypoxic event, emetic event and pain control.

ii The metric or method of measurement used

For parameters concerning patient's recovery, time to tolerate first food and water, time for mobilization will be measured from patient’s medical records.

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-09-20

27 Primary Registry and Trial Identifying Number

ChiCTR-IIC-17012635

28 Date of Registration in Primary Registry

2017-09-07

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Trial History Detail on 2018-09-19