Postpolypectomy BleedingNCT03400020
Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding
A study testing Ascorbic acid and Normal Saline in people with Postpolypectomy Bleeding, run by Ilam University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpolypectomy Bleeding
- What is being tested?
- Ascorbic acid and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteIran
- Study dates
- 28 Jan 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal polyps larger than 10 mm.
Who cannot join
- bleeding tendency poor preparation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Ascorbic acid, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidOther
Also called Vitamin C
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 SalineOther
Normal saline IV two hours before the operation and thereafter for three days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ascorbic acid |
| Normal saline | Placebo comparator | Normal saline IV infusion 2 hours before the operation and for three days after operation. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postpolypectomy bleeding
bleeding occurring either during an endoscopic procedure or immediately after as hematochezia within 24 hours following the polypectomy procedure.
Measured: up to 24 hours
Late postpolypectomy bleeding
bleeding occurring between day 2 and day 30 following the polypectomy procedure.
Measured: between day 2 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start28 Jan 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpolypectomy BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilam University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences
- Investigators
- Shaahin Shahbazi, MD, Study chair, Ilam University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400020
- Sponsor's protocol ID
- 13961019
- Status last verified
- Oct 2018
- First submitted
- 9 Jan 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin C Administration for the Prevention of Postpolypectomy Bleeding
- ClinicalTrials.gov ID
- NCT03400020
- Acronym / sponsor ID
- 13961019
- Conditions
- Postpolypectomy Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ilam University of Medical SciencesUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid | Experimental | Other: Ascorbic acidAscorbic acid 1000 mg in normal saline IV 2 hours before the operation and thereafter 500 mg in normal saline IV daily for three days. |
| Normal saline | Placebo comparator | Other: Normal SalineNormal saline IV infusion 2 hours before the operation and for three days after operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal polyps larger than 10 mm.
Key exclusion criteria (1 listed)
- bleeding tendency poor preparation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic acidAlso: Vitamin CAscorbic acid 500 Mg in normal saline IV two hours before the operation and thereafter 500 mg in normal saline IV daily for three days. | Other | Ascorbic acid |
| Normal SalineNormal saline IV two hours before the operation and thereafter for three days. | Other | Normal saline |
Primary outcome
Early postpolypectomy bleeding
Time frame: 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
Time frame: between day 2 and day 30
bleeding occurring between day 2 and day 30 following the polypectomy procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaahin Shahbazi, MD study chair
Ilam University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic acid and Normal Saline in people with Postpolypectomy Bleeding, run by Ilam University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postpolypectomy bleeding (time frame: up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.