NCT02188316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

July 7, 2014

Last Update Submit

July 10, 2014

Conditions

ColonoscopyPolypectomy

Keywords

Cold forceps polypectomyDiminutive colorectal polypHot biopsy forceps electrocauterizationJumbo forceps.

Outcome Measures

Primary Outcomes (1)

  • Complete eradication of diminutive polyps.

    3 months

Secondary Outcomes (1)

  • Adequate histopathological diagnosis

    3 months

Study Arms (2)

Jumbo forceps polypectomy

ACTIVE COMPARATOR

89 patients were randomized to jumbo forceps arm and 120 diminutive colorectal polyps were removed by jumbo forceps polypectomy.

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.

Device: Hot biopsy forceps

Interventions

Jumbo forcepsDEVICE

comparison of different polypectomy devices

Also known as: Jumbo forceps (Conmed, USA)
Jumbo forceps polypectomy
Hot biopsy forcepsDEVICE

comparison of different polypectomy devices

Also known as: Hot biopsy forceps (Wilson-Cook Medical, USA)
Hot biopsy electrocauterization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camlıca Erdem Hospital

Istanbul, 34660, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 11, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

TU(1)