Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02188316
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2014-07-07
Brief Title:
Comparison of Jumbo and Hot Biopsy Forceps
Sponsor:
Camlıca Erdem Hospital
Organization:
Camlıca Erdem Hospital
Study Overview
Official Title:
The Histological Quality and Adequacy of Diminutive Colorectal Polyps Resected Using Jumbo Versus Hot Biopsy Forceps
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cold forceps polypectomy and hot biopsy forceps electrocauterization HBF are still widely used methods for endoscopic resection of diminutive colorectal polyps DCPspolyps smaller than 5 mm Jumbo forceps may be more effective in the removal of DCPs because of their larger size
This was a prospective study of consecutive patients undergoing colonoscopy and found to have at least one diminutive polyp One experienced endoscopist removed DCPs using either jumbo or hot biopsy forceps
Aim was to evaluate the histological quality and adequacy of the DCPs resected using jumbo forceps in comparison with HBF
This was a prospective study of consecutive patients undergoing colonoscopy and found to have at least one diminutive polyp One experienced endoscopist removed DCPs using either jumbo or hot biopsy forceps
Aim was to evaluate the histological quality and adequacy of the DCPs resected using jumbo forceps in comparison with HBF
Detailed Description:
Exclusion criteria were i having abnormal coagulation parameters and thrombocytopenia taking aspirin or other medications which could affect bleeding time ii history of inflammatory bowel disease iii pregnancy
One experienced endoscopist carried out all the procedures using the same techniques
If a diminutive polyp was detected during colonoscopy and it was estimated that the polyp was eligible for the study the patient was randomly assigned by the physician to one of the two forceps groups hot biopsy versus jumbo forceps using a flipping coin method Polypectomy was then performed with the intention to remove all polypoid tissue with one forceps bite After the initial bite was obtained the polypectomy site was observed with visual inspection If residual polypoid tissue was observed after the first bite additional biopsies were taken until visual eradication was attained
The size of the polyp was estimated during colonoscopy by visual comparison with the open biopsy forceps Open-biopsy forceps technique Polypectomies were performed using jumbo forceps Conmed USA and hot biopsy forceps Wilson-Cook Medical USA For HBF the technique was based on the procedure first described in 1973 as follows slight pulling force was applied to the polyp and then the electrocautery current was applied until the white coagulum was seen at the polyp base The technique for jumbo forceps was as follows after initial grasping slight force was applied until the polyp was separated from the stalk The electrocautery current waveform and intensity settings were the same for each patient Each biopsy specimen was placed in a separate formalin solution
An experienced blinded pathologist evaluated the tissue samples for depth of specimen amount of cautery damage for hot biopsy forceps or crush artifacts for jumbo forceps architecture fragmentation overall diagnostic quality evaluation and positivity of surgical margins
All statistical analyses were performed using SPSS for Windows v 15 SPSS Inc Chicago IL USA Demographic biochemical and histopathological features were classified as continuous or categorical variables Kolmogorov-Smirnov analysis was used to test for Gaussian distribution The data were expressed as arithmetic mean standard deviation SD since the evaluated variables were Gaussian-distributed Comparisons between two groups were performed using the Students t-test for continuous variables Categorical variables were compared using the χ2 test 2X2 3X2 and 4X2 tables and Fishers exact test When the chi-square test was used Yates correction for continuity was used All reported p-values were two-tailed and those less than 005 were considered to be statistically significant
One experienced endoscopist carried out all the procedures using the same techniques
If a diminutive polyp was detected during colonoscopy and it was estimated that the polyp was eligible for the study the patient was randomly assigned by the physician to one of the two forceps groups hot biopsy versus jumbo forceps using a flipping coin method Polypectomy was then performed with the intention to remove all polypoid tissue with one forceps bite After the initial bite was obtained the polypectomy site was observed with visual inspection If residual polypoid tissue was observed after the first bite additional biopsies were taken until visual eradication was attained
The size of the polyp was estimated during colonoscopy by visual comparison with the open biopsy forceps Open-biopsy forceps technique Polypectomies were performed using jumbo forceps Conmed USA and hot biopsy forceps Wilson-Cook Medical USA For HBF the technique was based on the procedure first described in 1973 as follows slight pulling force was applied to the polyp and then the electrocautery current was applied until the white coagulum was seen at the polyp base The technique for jumbo forceps was as follows after initial grasping slight force was applied until the polyp was separated from the stalk The electrocautery current waveform and intensity settings were the same for each patient Each biopsy specimen was placed in a separate formalin solution
An experienced blinded pathologist evaluated the tissue samples for depth of specimen amount of cautery damage for hot biopsy forceps or crush artifacts for jumbo forceps architecture fragmentation overall diagnostic quality evaluation and positivity of surgical margins
All statistical analyses were performed using SPSS for Windows v 15 SPSS Inc Chicago IL USA Demographic biochemical and histopathological features were classified as continuous or categorical variables Kolmogorov-Smirnov analysis was used to test for Gaussian distribution The data were expressed as arithmetic mean standard deviation SD since the evaluated variables were Gaussian-distributed Comparisons between two groups were performed using the Students t-test for continuous variables Categorical variables were compared using the χ2 test 2X2 3X2 and 4X2 tables and Fishers exact test When the chi-square test was used Yates correction for continuity was used All reported p-values were two-tailed and those less than 005 were considered to be statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None