Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

NCT03400020 | Completed

• 1 other identifier: 13961019
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpolypectomy Bleeding

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Ascorbic acid

EXPERIMENTAL

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

Normal saline

PLACEBO COMPARATOR

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

Other: Normal Saline

Interventions

Ascorbic acid 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.

Also known as: Vitamin C

Ascorbic acid

Normal Saline OTHER

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

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colorectal polyps larger than 10 mm.

You may not qualify if:

• bleeding tendency poor preparation

Sponsors & Collaborators

• Ilam University of Medical Sciences: lead

Study Sites (1)

Mostafa Khomaini Hospital

Īlām, Iran

Location

MeSH Terms

Interventions

Ascorbic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shaahin Shahbazi, MD

  Ilam University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: January 28, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)