Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00077

2 Trial Registration Date

2005-09-13

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Not supported by any grant

5 Primary Sponsor

Department of Surgery, PWH, the Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Leung Ka Lau

ii Address

iii Phone

SMO, Department of Surgery, PWH.

iv Email

leungkl@msn.com

v Affiliation

vi Country

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

i Name

Leung Ka Lau

ii Address

iii Phone

SMO, Department of Surgery, PWH.

iv Email

leungkl@msn.com

v Affiliation

vi Country

9 Official Scientific Title of the Study

Prospective randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colorectal Carcinoma

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

1998-05-15

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Cancers and other Neoplasms

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Laparoscopic assisted colorectal resection

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Operative time

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Conventional open colorectal resection

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

Inclusion criteria: Colorectal cancer. Exclision criteria: 1) Patients with tumour larger than 6cm or with tumour infiltrating to the adjacent organs on sonography and/or computerized tomography. 2) Patients with previous major abdominal operations near to the field of the colorectal operation. 3) Patients who do not consent to the randomization. 4) Patients who present with intestinal obstruction or perforation. 5) Patients who are considered unsuitable by the principle investigators.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

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

1998-05-15

21 Target Sample Size

800

22 Recruitment Status

Recruiting

23 Primary Outcome

Overall Survival, disease free interval

24 Secondary Outcome

Post-operative morbidity, mortality, and recovery

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-09-13