An interventional study of hot snare polypectomy and hot snare polypectomy after saline injection in Polyp of Large Intestine, sponsored by Bo-In Lee. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by Bo-In Lee · Not applicable, Interventional, and Treatment
The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.
385 studies on the registry are indexed under Polyps; 59 are open to participants now.
This study's enrollment of 362 is above the median of 160 across 250 interventional studies indexed under Polyps.
Browse Polyps studies →Bo-In Lee is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique
Procedure: hot snare polypectomy
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique
Procedure: hot snare polypectomy after saline injection
hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
Complete Resection Rate
Complete resection was defined as the absence of residual polyp in the resection margin
Time frame: 2 weeks after
Lateral Margin
Observation of maring on a recsected specimen
Time frame: 2 weeks after
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.
| Milestone | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) |
|---|---|---|
| Started | 190 | 172 |
| Completed | 167 | 155 |
| Not completed | 23 | 17 |
| Withdrew: Non-neoplastic polyp | 23 | 17 |
Complete resection was defined as the absence of residual polyp in the resection margin
| Participants | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) |
|---|---|---|
| Complete resection | 161 | 148 |
| Incomplete resection | 6 | 7 |
Observation of maring on a recsected specimen
| Participants | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) |
|---|---|---|
| Negative | 83 | 116 |
| Positive | 3 | 2 |
| Inconclusive | 91 | 37 |
Collected over 2 weeks after polypectomy. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hot Snare Polypectomy | 0/167 (0%) | 0/167 (0%) | 17/167 (10.2%) |
| Hot Snare Polypectomy(Saline Injection) | 0/155 (0%) | 0/155 (0%) | 13/155 (8.4%) |
| Event | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) |
|---|---|---|
| PerforationGastrointestinal disorders | 0/167 | 0/155 |
| Event | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) |
|---|---|---|
| Immediate bleedingGastrointestinal disorders | 17/167 | 12/155 |
| Delayed bleedingGastrointestinal disorders | 0/167 | 1/155 |
| Post-polypectomy syndromeGastrointestinal disorders | 0/167 | 0/155 |
| Age, Continuous(years) | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) | Total |
|---|---|---|---|
| Mean | 62.8 ± 10.7 | 63.0 ± 10.8 | 62.9 ± 10.7 |
| Sex/Gender, Customized(participants) | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) | Total |
|---|---|---|---|
| Male | 114 | 98 | 212 |
| Female | 53 | 57 | 110 |
| Ethnicity (NIH/OMB)(Participants) | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 167 | 155 | 322 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Hot Snare Polypectomy | Hot Snare Polypectomy(Saline Injection) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 167 | 155 | 322 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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