Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000842460
Ethics application status
Approved
Date submitted
16/06/2016
Date registered
28/06/2016
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the efficiency of 2 cold snare polypectomy techniques during colonoscopy
Scientific title
Efficiency of Snare-WithIn-The-scope-Channel (SWITCH) Technique During Cold Snare Polypectomy in Patients Undergoing Elective Colonoscopy: A randomised controlled trial (SWITCH Trial)
Secondary ID [1] 289470 0
Nil known
Universal Trial Number (UTN)
U1111-1184-3278
Trial acronym
SWITCH Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 299151 0
Condition category
Condition code
Cancer 299167 299167 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 299265 299265 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional Procedure (Arm 1): Snare-WithIn-The-scope-CHannel (SWITCH) Cold Snare Polypectomy

In this arm, all polyps encountered during colonoscopy will be removed by SWITCH cold polypectomy technique. This involved advancement of the snare which is already in the scope channel, transecting the polyp (i.e. polypectomy), then partially withdrawing the snare into the channel (without removing the snare from the scope channel) prior to suctioning the polyp for retrieval. All further polyps encountered in the same patient will be removed by the same technique.

All procedures will be performed by 2 consultant gastroenterologists with expertise in therapeutic colonoscopy. The procedure duration is similar to any standard colonoscopy and is allocated half an hour slot in the weekday elective endoscopy list. Duration can vary depending on number of polyps encountered.
Intervention code [1] 295052 0
Treatment: Devices
Intervention code [2] 295138 0
Treatment: Surgery
Comparator / control treatment
Comparator/Control Procedure (Arm 2): Conventional Cold Snare Polypectomy

In this arm, all polyps encountered during colonoscopy will be removed by conventional cold snare polypectomy. This involves insertion of snare into the scope channel, transecting the polyp (i.e. polypectomy), then removing the snare out of the scope channel prior to suctioning the polyp for retrieval. All further polyps encountered in the same patient will be removed by the same technique.

All procedures will be performed by 2 consultant gastroenterologists with expertise in therapeutic colonoscopy. The procedure duration is similar to any standard colonoscopy and is allocated half an hour slot in the weekday elective endoscopy list. Duration can vary depending on number of polyps encountered.
Control group
Active

Outcomes
Primary outcome [1] 298652 0
- Mean total polypectomy time per patient

The total polypectomy time is defined as the total time from a polyp has been detected detected by the endoscopist until the polyp has been transected, then has been suctioned and has reached the trap (i.e. from polyp detection until polyp reaching the trap) , as measured by the research assistant with a stop watch.
Timepoint [1] 298652 0
Assessed from polyp detection until polyp retrieval into the trap.
Secondary outcome [1] 325129 0
- Mean total procedure time per patient.

Total procedure time is defined by the time from when the procedure starts (i.e. scope tip inserted into the anus of the patient) until the procedure has finished (i.e. scope tip has been withdrawn from anus of the patient).
Timepoint [1] 325129 0
From scope insertion into the anus of the patient (i.e. start of the procedure) until scope withdrawn out of the anus of the patient (i.e. end of the procedure).

Eligibility
Key inclusion criteria
- All patients undergoing elective colonoscopy (screening, surveillance and diagnostic).
- Eligible participants need to have at least one polyp measuring 9mm or more.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients under 18 years.
- Complex cases for advanced therapeutic colonoscopy (endoscopic mucosal resection, endoscopic submucosal dissection, colonic stenting, colonic dilatation, colonic strictures).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
- Sequentially numbered, opaque, sealed envelopes (SNOSE).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
- Simple randomisation using a randomisation table created by computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming a 30% difference (reduced mean of total polypectomy times for snare-within-the-scope-channel (SWITCH) technique over conventional technique, we will need 352 patients (176 each arm) with 5% drop rate (18 patients). So the total number of patients in the study is 370 patients.
alpha=0.05, power=80%, delta 30%, sd=1, estimated sample size: N=352 (N per group = 176), 5% drop rate=18.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
Date of last participant enrolment
Anticipated
31/07/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5988 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 13410 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 293834 0
Hospital
Name [1] 293834 0
Queen Elizabeth II Jubilee Hospital
Country [1] 293834 0
Australia
Primary sponsor type
Hospital
Name
Queen Elizabeth II Jubilee Hospital
Address
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD 4108, Australia
Country
Australia
Secondary sponsor category [1] 292666 0
None
Name [1] 292666 0
Address [1] 292666 0
Country [1] 292666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295262 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 295262 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Queensland 4102
Ethics committee country [1] 295262 0
Australia
Date submitted for ethics approval [1] 295262 0
18/05/2016
Approval date [1] 295262 0
31/05/2016
Ethics approval number [1] 295262 0
HREC/16/QPAH/395

Summary
Brief summary
This study aims to compare the efficiency of two common procedures for the removal of colorectal polyps.

Who is it for?
You may be eligible to join this study if:
- You are aged 18 years or above,
- Are undergoing elective colonoscopy,
- And have at least one colorectal polyp of size 9mm or less.

Study details:
Participants in this study will be randomly allocated (by chance) to one of two groups.

Participants in one group will undergo conventional cold snare polypectomy. This involves inserting the polyp removal device (i.e. the snare) into the colonoscope channel for removing your polyp. Then removing the snare out of the colonoscope channel prior to retrieving your polyp.

Participants in the other group will undergo snare-within-the-scope-channel (SWITCH) cold snare polypectomy. This involves leaving the polyp removal device (i.e. the snare) in the scope channel prior to and after removing your polyp, and during retrieval of your polyp.

Participants will not know which group they are in until after the study is completed. Procedure time will be measured in all participants and compared across groups. This will enable us to determine which of the two procedures is more efficient.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 931 931 0 0
/AnzctrAttachments/370913-Ethics approval.pdf
Attachments [2] 932 932 0 0
/AnzctrAttachments/370913-NEAF SWITCH study.pdf
Attachments [3] 935 935 0 0
/AnzctrAttachments/370913-Form SWITCH study.docx
Attachments [4] 940 940 0 0
/AnzctrAttachments/370913-SWITCH Study Protocol Endoscopist and Nurse.docx
Attachments [5] 941 941 0 0
/AnzctrAttachments/370913-SWITCH Study Protocol Research Assistant.docx

Contacts
Principal investigator
Name 66710 0
Dr Ammar Kheir
Address 66710 0
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD 4108, Australia
Country 66710 0
Australia
Phone 66710 0
+61 424266194
Fax 66710 0
Email 66710 0
[email protected]
Contact person for public queries
Name 66711 0
Dr Ammar Kheir
Address 66711 0
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD 4108, Australia
Country 66711 0
Australia
Phone 66711 0
+61 424266194
Fax 66711 0
Email 66711 0
[email protected]
Contact person for scientific queries
Name 66712 0
Dr Ammar Kheir
Address 66712 0
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD 4108, Australia
Country 66712 0
Australia
Phone 66712 0
+61 424266194
Fax 66712 0
Email 66712 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.