Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

NCT ID: NCT03400020

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-28
• Study Completion Date: 2018-09-30

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.

Conditions

Postpolypectomy Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ascorbic acid

Intervention Type: OTHER

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.

Normal saline

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

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: OTHER

Normal saline IV two hours before the operation and thereafter for three days.

Interventions

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.

Intervention Type: OTHER

Normal Saline

Normal saline IV two hours before the operation and thereafter for three days.

Intervention Type: OTHER

Other Intervention Names

Vitamin C

Eligibility Criteria

Inclusion Criteria

• Colorectal polyps larger than 10 mm.

Exclusion Criteria

bleeding tendency poor preparation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ilam University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Vahdat Shariatpanahi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaahin Shahbazi, MD

Role: STUDY_CHAIR

Ilam University of Medical Sciences

Locations

Mostafa Khomaini Hospital

Īlām, , Iran

Countries

Iran

Other Identifiers

13961019

Identifier Type: -

Identifier Source: org_study_id

NCT03374410

Identifier Type: -

Identifier Source: nct_alias