ColonoscopyNCT02188316
Comparison of Jumbo and Hot Biopsy Forceps
A study testing Jumbo forceps and Hot biopsy forceps in people with Colonoscopy and Polypectomy, run by Camlıca Erdem Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Polypectomy
- What is being tested?
- Jumbo forceps and Hot biopsy forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2014to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients found to have at least one diminutive polyp (measuring ≤ 5 mm).
Who cannot join
- Having abnormal coagulation parameters and thrombocytopenia
- Taking aspirin or other medications which could affect bleeding time
- History of inflammatory bowel disease
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Histological Quality and Adequacy of Diminutive Colorectal Polyps Resected Using Jumbo Versus Hot Biopsy Forceps
- 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.
Read the 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.
- Conditions
- Colonoscopy, Polypectomy
- Being tested
- Jumbo forceps, Hot biopsy forceps
- Keywords
- Cold forceps polypectomy, Diminutive colorectal polyp, Hot biopsy forceps electrocauterization, Jumbo forceps.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jumbo forcepsDevice
Also called Jumbo forceps (Conmed, USA)
comparison of different polypectomy devices
Hot biopsy forcepsDevice
Also called Hot biopsy forceps (Wilson-Cook Medical, USA)
comparison of different polypectomy devices
| Study group | Role | What they receive |
|---|---|---|
| Jumbo forceps polypectomy | Active comparator | 89 patients were randomized to jumbo forceps arm and 120 diminutive colorectal polyps were removed by jumbo forceps polypectomy. Receives: Device: Jumbo forceps |
| Hot biopsy electrocauterization | Active comparator | 90 patients were randomized to hot biopsy forceps arm and 117 diminutive colorectal polyps were removed by hot biopsy electrocauterization. Receives: Device: Hot biopsy forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete eradication of diminutive polyps.
Measured: 3 months
Secondary outcomes (1)
Adequate histopathological diagnosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camlıca Erdem Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Yasar, Camlıca Erdem Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188316
- Sponsor's protocol ID
- HNEAH-KAEK 2014/22
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Histological Quality and Adequacy of Diminutive Colorectal Polyps Resected Using Jumbo Versus Hot Biopsy Forceps
- ClinicalTrials.gov ID
- NCT02188316
- Acronym / sponsor ID
- HNEAH-KAEK 2014/22
- Conditions
- Colonoscopy, Polypectomy
- Keywords
- Cold forceps polypectomy, Diminutive colorectal polyp, Hot biopsy forceps electrocauterization, Jumbo forceps.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Camlıca Erdem HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jumbo forceps polypectomy | Active comparator | Device: Jumbo forceps89 patients were randomized to jumbo forceps arm and 120 diminutive colorectal polyps were removed by jumbo forceps polypectomy. |
| Hot biopsy electrocauterization | Active comparator | Device: Hot biopsy forceps90 patients were randomized to hot biopsy forceps arm and 117 diminutive colorectal polyps were removed by hot biopsy electrocauterization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients found to have at least one diminutive polyp (measuring ≤ 5 mm).
Key exclusion criteria (4 listed)
- Having abnormal coagulation parameters and thrombocytopenia
- Taking aspirin or other medications which could affect bleeding time
- History of inflammatory bowel disease
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jumbo forcepsAlso: Jumbo forceps (Conmed, USA)comparison of different polypectomy devices | Device | Jumbo forceps polypectomy |
| Hot biopsy forcepsAlso: Hot biopsy forceps (Wilson-Cook Medical, USA)comparison of different polypectomy devices | Device | Hot biopsy electrocauterization |
Primary outcome
Complete eradication of diminutive polyps.
Time frame: 3 months
1 secondary outcome
Adequate histopathological diagnosis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jumbo forceps and Hot biopsy forceps in people with Colonoscopy and Polypectomy, run by Camlıca Erdem Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete eradication of diminutive polyps. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.