Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

Not Applicable

Completed

• Conditions: Postpolypectomy Bleeding
• Interventions: Other: Normal Saline; Other: Ascorbic acid

• Registration Number: NCT03400020
• Lead Sponsor: Ilam University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Study Start: 2018-01-28
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Colorectal polyps larger than 10 mm.

Exclusion Criteria

bleeding tendency poor preparation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal Saline	Normal saline IV infusion 2 hours before the operation and for three days after operation.
Ascorbic acid	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mostafa Khomaini Hospital; 🇮🇷 Ilam, Iran, Islamic Republic of