Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

Postpolypectomy Bleeding Clinical Trial

Official title:

Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400020
• Other study ID #: 13961019
• Status: Completed
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: Ilam University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03374410

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Colorectal polyps larger than 10 mm.

Exclusion Criteria:

bleeding tendency poor preparation

Related Conditions & MeSH terms

• Hemorrhage
• Postpolypectomy Bleeding

Intervention

Other:
• 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.
• Normal Saline
Normal saline IV two hours before the operation and thereafter for three days.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mostafa Khomaini Hospital	Ilam

Sponsors (1)

Lead Sponsor	Collaborator
Ilam University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Late postpolypectomy bleeding	bleeding occurring between day 2 and day 30 following the polypectomy procedure.	between day 2 and day 30