DeFect cLOsure After Colonic ESD With underwaTer Technique
FLOAT
1 other identifier
interventional
64
1 country
1
Brief Summary
This is a single centre randomised controlled study comparing underwater clip closure versus conventional gas insufflation clip closure of post-resection defect in patients undergoing colonic endoscopic resection. The investigators hypothesize that underwater clip closure would be faster than conventional closure under gas insufflation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 23, 2023
August 1, 2023
3 years
December 28, 2019
August 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time required to complete clip closure of mucosal defect
o Defined as the time from completion of prophylactic coagulation till the final clip application (min)
Within 1 hour
Secondary Outcomes (7)
Technical success of complete closure of defect (%)
Within 1 hour
Total time for endoscopic procedure (min)
Within 1 hour
Number of endoscopic clip used for closure
Within 1 hour
Rate of Haemorrhage
30 days
Rate of Perforation
30 days
- +2 more secondary outcomes
Study Arms (2)
Underwater clip closure
EXPERIMENTALThe post-resection defect is closed using endoscopic clips with underwater technique
Conventional clip closure
ACTIVE COMPARATORThe post-resection defect is closed using endoscopic clips with conventional gas insufflation (CO2)
Interventions
Closure of post-resection defect with endoscopic clips by underwater technique
Closure of post-resection defect with endoscopic clip by conventional technique
Eligibility Criteria
You may qualify if:
- Patients undergoing elective endoscopic resection
- Colorectal superficial neoplasm with a resultant mucosal defect of ≥20mm
- Age \>18 years old
You may not qualify if:
- Patients on anticoagulation (Warfarin or other direct oral anticoagulants)
- Muscular perforation during the endoscopic resection
- Incomplete endoscopic resection
- Lesions arising from surgical anastomotic site
- Marked electrolyte abnormalities
- Other cases deemed by the examining physician as unsuitable for safe treatment
- Patients who refused to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hon Chi Yip, MBChB
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Consultant
Study Record Dates
First Submitted
December 28, 2019
First Posted
January 2, 2020
Study Start
July 1, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share