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Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

I

Ilam University of Medical Sciences

Status

Completed

Conditions

Postpolypectomy Bleeding

Treatments

Other: Normal Saline
Other: Ascorbic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT03400020
13961019

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Colorectal polyps larger than 10 mm.

Exclusion criteria

bleeding tendency poor preparation

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

156 participants in 2 patient groups, including a placebo group

Ascorbic acid
Experimental group
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.
Treatment:
Other: Ascorbic acid
Normal saline
Placebo Comparator group
Description:
Normal saline IV infusion 2 hours before the operation and for three days after operation.
Treatment:
Other: Normal Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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