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Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

Primary Purpose

Postpolypectomy Bleeding

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ascorbic acid
Normal Saline
Sponsored by
Ilam University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpolypectomy Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Colorectal polyps larger than 10 mm.

Exclusion Criteria:

bleeding tendency poor preparation

Sites / Locations

  • Mostafa Khomaini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ascorbic acid

Normal saline

Arm Description

Ascorbic acid 1000 mg in normal saline IV 2 hours before the operation and thereafter 500 mg in normal saline IV daily for three days.

Normal saline IV infusion 2 hours before the operation and for three days after operation.

Outcomes

Primary Outcome Measures

Early postpolypectomy bleeding
bleeding occurring either during an endoscopic procedure or immediately after as hematochezia within 24 hours following the polypectomy procedure.
Late postpolypectomy bleeding
bleeding occurring between day 2 and day 30 following the polypectomy procedure.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2018
Last Updated
October 17, 2018
Sponsor
Ilam University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03400020
Brief Title
Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding
Official Title
Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ilam University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Postpolypectomy bleeding is the most common major complication following a colonoscopic polypectomy procedure. The incidence rate ranging from 0.3 to 6.1%. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. It has been demonstrated that administration of ascorbic acid (vitamin C) in abdominal surgeries could reduce the blood loss during the procedure, operation time and days of hospitalization. So the investigators designed a prospective, randomized study to compares the efficacy of vitamin C administration with application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps.
Detailed Description
In this prospective, randomized clinical trial, patients diagnosed with colon polyps with a diameter > 10 mm will randomized to receive either a 500 mg vitamin C in normal saline injection or a normal saline injection 2 hours before polypectomy. This administration will continued for 3 days after polypectomoy. Postpolypectomy bleeding is defined either as (1) early: occurring either during an endoscopic procedure or immediately after as hematochezia within 24 h or (2) delayed: any bleeding event that occurring between day 2 and day 30 following the polypectomy procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpolypectomy Bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ascorbic acid
Arm Type
Experimental
Arm Description
Ascorbic acid 1000 mg in normal saline IV 2 hours before the operation and thereafter 500 mg in normal saline IV daily for three days.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline IV infusion 2 hours before the operation and for three days after operation.
Intervention Type
Other
Intervention Name(s)
Ascorbic acid
Other Intervention Name(s)
Vitamin C
Intervention Description
Ascorbic acid 500 Mg in normal saline IV two hours before the operation and thereafter 500 mg in normal saline IV daily for three days.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Normal saline IV two hours before the operation and thereafter for three days.
Primary Outcome Measure Information:
Title
Early postpolypectomy bleeding
Description
bleeding occurring either during an endoscopic procedure or immediately after as hematochezia within 24 hours following the polypectomy procedure.
Time Frame
up to 24 hours
Title
Late postpolypectomy bleeding
Description
bleeding occurring between day 2 and day 30 following the polypectomy procedure.
Time Frame
between day 2 and day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colorectal polyps larger than 10 mm. Exclusion Criteria: bleeding tendency poor preparation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaahin Shahbazi, MD
Organizational Affiliation
Ilam University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Mostafa Khomaini Hospital
City
Ilam
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

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