Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

Conditions
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Postpolypectomy Bleeding

Intervention / Treatment
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* Other: Ascorbic acid
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colorectal polyps larger than 10 mm. Exclusion Criteria: bleeding tendency poor preparation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascorbic acid<br>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<br>* 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.<br>* Other names: Vitamin C;|
| Placebo Comparator: Normal saline<br>Normal saline IV infusion 2 hours before the operation and for three days after operation. | Other: Normal Saline<br>* Normal saline IV two hours before the operation and thereafter for three days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early postpolypectomy bleeding | 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 | bleeding occurring between day 2 and day 30 following the polypectomy procedure. | between day 2 and day 30 |