Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

October 17, 2018 updated by: Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Colorectal polyps larger than 10 mm.

Exclusion Criteria:

bleeding tendency poor preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ascorbic acid
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.
Other: Ascorbic acid
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.
Other Names:
  • Vitamin C
Placebo Comparator: Normal saline
Normal saline IV infusion 2 hours before the operation and for three days after operation.
Other: Normal Saline
Normal saline IV two hours before the operation and thereafter for three days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postpolypectomy bleeding
Time Frame: up to 24 hours
bleeding occurring either during an endoscopic procedure or immediately after as hematochezia within 24 hours following the polypectomy procedure.
up to 24 hours
Late postpolypectomy bleeding
Time Frame: between day 2 and day 30
bleeding occurring between day 2 and day 30 following the polypectomy procedure.
between day 2 and day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilam University of Medical Sciences

Investigators

  • Study Chair: Shaahin Shahbazi, MD, Ilam University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 9, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13961019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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