Centre For Clinical Research And Biostatistics (CCRB)

Back

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00159

2 Trial Registration Date

2008-04-24

i Registration Status

Retrospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Ms. Jacqueline Shum

ii Address

iii Phone

jacqshum@cuhk.edu.hk

iv Email

2632-2878

v Affiliation

vi Country

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

i Name

Dr. Kelvin K.L.Chong

ii Address

iii Phone

chongkamlung@gmail.com

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Prospective randomized study of silicone stent intubation in endoscopic dacryocysto-rhinostomy for acquired nasolacrimal duct obstruction - SEND study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

SEND study

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-04-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Acquired nasolacrimal duct obstruction

15 Intervention

i Types of intervention

Other

Please specify

Device + procedure

ii Description/ name of Intervention/article

endoscopic dacryocysto-rhinostomy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Stenting: 8 weeks or no stent at all Follow-up: 26 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Endoscopic dacryocystorhinostomy with or without eight weeks bicanalicular silicone intubation

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 1. Adult patients (>18) with NLDO (on table finding) 2. Informed consent 3. Follow-up to 6 months 4. No previous lacrimal surgery 5. No concomitant canalicular disease 6. Agree for randomization Exclusion criteria 1. Previous dacryocystorhinostomy 2. Canalicular obstruction requiring membranectomy after sac exposure for free passage of Bowman probe 3. Requiring concomitant punctoplasty procedure

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

Uncontrolled

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

2006-04-05

21 Target Sample Size

160

22 Recruitment Status

Recruiting

23 Primary Outcome

% of success achieved in each group at postoperative six months % with formation of granulation tissue at rhinostomy site, time course, response to local debridement and nasal steroid spray

24 Secondary Outcome

Risk factors analyses for surgical failure or persistence of symptom (age, gender, duration of symptom preoperatively, postoperative tube prolapse, presence of granulation tissue around internal ostium, difficulty intraoperative hemostasis, surgeon¡¦s immediate impression, level of surgical experience, endoscopist¡¦s assessment postoperatively) Mean time to failure postoperatively (weeks) Complications rate: orbital fat prolapse, epistaxis, infection, tube prolapse, canalicular laceration, synechiae, additional surgery

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

n/a

Back

Trial History Detail on 2008-05-05