Trial Outcomes & Findings for Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps (NCT NCT02239536)
NCT ID: NCT02239536
Last Updated: 2020-04-14
Results Overview
Complete resection was defined as the absence of residual polyp in the resection margin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
362 participants
Primary outcome timeframe
2 weeks after
Results posted on
2020-04-14
Participant Flow
Patients were excluded if they have (1) a bleeding tendency or ever taken antiplatelet or anticoagulation therapy within 1 week before undergoing the procedure, (2) An inflammatory bowel disease, (3) a polyposis syndrome, or (4) an inability to provide informed consent.
Participant milestones
| Measure |
Hot Snare Polypectomy
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
|
Hot Snare Polypectomy(Saline Injection)
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
|
|---|---|---|
|
Overall Study
STARTED
|
190
|
172
|
|
Overall Study
COMPLETED
|
167
|
155
|
|
Overall Study
NOT COMPLETED
|
23
|
17
|
Reasons for withdrawal
| Measure |
Hot Snare Polypectomy
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
|
Hot Snare Polypectomy(Saline Injection)
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
|
|---|---|---|
|
Overall Study
Non-neoplastic polyp
|
23
|
17
|
Baseline Characteristics
Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps
Baseline characteristics by cohort
| Measure |
Hot Snare Polypectomy
n=167 Participants
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
|
Hot Snare Polypectomy(Saline Injection)
n=155 Participants
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
63.0 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
62.9 years
STANDARD_DEVIATION 10.7 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
114 participants
n=99 Participants
|
98 participants
n=107 Participants
|
212 participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
53 participants
n=99 Participants
|
57 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
167 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
322 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
167 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
322 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeks afterComplete resection was defined as the absence of residual polyp in the resection margin
Outcome measures
| Measure |
Hot Snare Polypectomy
n=167 Participants
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
|
Hot Snare Polypectomy(Saline Injection)
n=155 Participants
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
|
|---|---|---|
|
Complete Resection Rate
Complete resection
|
161 Participants
|
148 Participants
|
|
Complete Resection Rate
Incomplete resection
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 weeks afterObservation of maring on a recsected specimen
Outcome measures
| Measure |
Hot Snare Polypectomy
n=167 Participants
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
|
Hot Snare Polypectomy(Saline Injection)
n=155 Participants
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
|
|---|---|---|
|
Lateral Margin
Negative
|
83 Participants
|
116 Participants
|
|
Lateral Margin
Positive
|
3 Participants
|
2 Participants
|
|
Lateral Margin
Inconclusive
|
91 Participants
|
37 Participants
|
Adverse Events
Hot Snare Polypectomy
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Hot Snare Polypectomy(Saline Injection)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hot Snare Polypectomy
n=167 participants at risk
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
|
Hot Snare Polypectomy(Saline Injection)
n=155 participants at risk
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
|
|---|---|---|
|
Gastrointestinal disorders
Perforation
|
0.00%
0/167 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
0.00%
0/155 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
Other adverse events
| Measure |
Hot Snare Polypectomy
n=167 participants at risk
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
|
Hot Snare Polypectomy(Saline Injection)
n=155 participants at risk
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
|
|---|---|---|
|
Gastrointestinal disorders
Immediate bleeding
|
10.2%
17/167 • Number of events 17 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
7.7%
12/155 • Number of events 12 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
|
Gastrointestinal disorders
Delayed bleeding
|
0.00%
0/167 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
0.65%
1/155 • Number of events 1 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
|
Gastrointestinal disorders
Post-polypectomy syndrome
|
0.00%
0/167 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
0.00%
0/155 • 2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place