Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00374

2 Trial Registration Date

2013-07-16

i Registration Status

Prospective

3 Secondary IDs

NTWC/CREC/1123/13

4 Source(s) of Funding

not applicable

5 Primary Sponsor

Hospital Authority

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Leung Siu Kee

ii Address

Deprtment of Surgey, Tuen Mun Hospital,Tuen Mun, Hong Kong

iii Phone

852-24685379

iv Email

drleungsk@hotmail.com

v Affiliation

Department of Surgery, Tuen Mun Hospital

vi Country

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

i Name

Leung Siu Kee

ii Address

Department of Surgery, Tuen Mun Hospital, Tuen Mun, Hong Kong

iii Phone

852-24685379

iv Email

drleungsk@hotmail.com

v Affiliation

Department of Surgery, Tuen Mun Hospital

vi Country

9 Official Scientific Title of the Study

Randomized trial on the use of nasogastric and nasojejunal tubes (Ryle's tubes) after gastrectomy for cancer

10 Public Title

Randomized trial on the use of nasogastric and nasojejunal tubes (Ryle's tubes) after gastrectomy for cancer

i Public Title in Chinese 研究名稱

胃癌切除術後放置胃引流管及小腸引流管之前瞻性隨機抽樣研究

11 Short Title (Optional)

RCT on nasogastric and nasojejunal tubes

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-06-24

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

gastric cancer

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

removal of nasogastric or nasojejunal tube in OT theatre after gastrectomy for cancer

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

from end of operation to resumption of oral feeding, usually around 3 days

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

keeping the nasogastric or nasojejunal tube after gastrectomy for cancer

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Patients undergoing elective operations for gastric cancer
2. Age of patients >=18 and <=80
3. Patients are mentally fit to sign consent and understand the context of the study

ii Exclusion Criteria

1. There is clinical and radiological evidence of gastric outlet obstruction
2. There is clinical and radiological evidence of intestinal obstruction
3. The patient will exit from study if tumor is non-resectable at operation
4. ASA >2

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-08-02

21 Target Sample Size

140

22 Recruitment Status

Recruiting

23 Primary Outcome

Pulmonary complications rate, degree of throat discomfort, need to insert NG or NJ tube in ward, postoperative length of stay
Pulmonary complication is defined as having radiological evidence of consolidation, collapse or effusion and evidence of infection
Throat discomfort is measured by grading (grade 0 = nil, grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 =intolerable). This score is measured on postoperative day 2 and on the day of starting fluid diet.
Length of stay is measured from the operation day to the discharge day (to home or convalescent bed).

24 Secondary Outcome

Anastomotic leakage rate, reoperation, mortality

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-20

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003340

28 Date of Registration in Primary Registry

2013-07-19

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

PI's email

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Trial History Detail on 2013-07-19