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Comparison of Jumbo and Hot Biopsy Forceps

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ClinicalTrials.gov Identifier: NCT02188316
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Bulent Yasar, Camlıca Erdem Hospital

Brief Summary:
  • Cold forceps polypectomy and hot biopsy forceps electrocauterization (HBF) are still widely used methods for endoscopic resection of diminutive colorectal polyps (DCPs)(polyps 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Polypectomy Device: Jumbo forceps Device: Hot biopsy forceps Not Applicable

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 Student's t-test for continuous variables. Categorical variables were compared using the χ2 test (2X2, 3X2 and 4X2 tables) and Fisher's 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 0.05 were considered to be statistically significant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Histological Quality and Adequacy of Diminutive Colorectal Polyps Resected Using Jumbo Versus Hot Biopsy Forceps
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Jumbo forceps polypectomy
89 patients were randomized to jumbo forceps arm and 120 diminutive colorectal polyps were removed by jumbo forceps polypectomy.
Device: Jumbo forceps
comparison of different polypectomy devices
Other Name: Jumbo forceps (Conmed, USA)

Active Comparator: Hot biopsy electrocauterization
90 patients were randomized to hot biopsy forceps arm and 117 diminutive colorectal polyps were removed by hot biopsy electrocauterization.
Device: Hot biopsy forceps
comparison of different polypectomy devices
Other Name: Hot biopsy forceps (Wilson-Cook Medical, USA)




Primary Outcome Measures :
  1. Complete eradication of diminutive polyps. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Adequate histopathological diagnosis [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients found to have at least one diminutive polyp (measuring ≤ 5 mm).

Exclusion Criteria:

  • Having abnormal coagulation parameters and thrombocytopenia
  • Taking aspirin or other medications which could affect bleeding time
  • History of inflammatory bowel disease
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188316


Locations
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Turkey
Camlıca Erdem Hospital
Istanbul, Turkey, 34660
Sponsors and Collaborators
Camlıca Erdem Hospital
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Responsible Party: Bulent Yasar, MD, Camlıca Erdem Hospital
ClinicalTrials.gov Identifier: NCT02188316    
Other Study ID Numbers: HNEAH-KAEK 2014/22
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Keywords provided by Bulent Yasar, Camlıca Erdem Hospital:
Cold forceps polypectomy
Diminutive colorectal polyp
Hot biopsy forceps electrocauterization
Jumbo forceps.