Polyp ColorectalNCT03989791
The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial
A study testing absolute diet and normal diet in people with Polyp Colorectal, run by Nanfang Hospital, Southern Medical University.
Trial summary
There is no evidence to prove the impact of post-procedural diet on post-polypectomy bleeding (PPB) or delayed perforation. No relevant study has been conducted and it is yet to be determined if absolute diet is necessary for post-polypectomy patients, and the comparison between normal diet and absolute diet also… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Polyp Colorectal
- What is being tested?
- absolute diet and normal diet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2019to 20 Jul 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 patient with initial diagnosis of colorectal polyp by colonoscopy;
- The maximum size of polyp is more than 20mm;
- The patients underwent single ESD procedure for the polyp and agreed to participate this trial.
Who cannot join
- Uncontrollable hypertension or diabetes；
- Severe comorbidities such as cancer and organ failure etc；
- Patients who were pregnant;
- Patients had anticoagulants during perioperative period;
- Patients with poor compliance. -
About this study
There is no evidence to prove the impact of post-procedural diet on post-polypectomy bleeding (PPB) or delayed perforation. No relevant study has been conducted and it is yet to be determined if absolute diet is necessary for post-polypectomy patients, and the comparison between normal diet and absolute diet also remains unclear. Therefore, we carried out this randomized controlled study to evaluate and compare tthe clinical effect of different diets on post-polypectomy patients.
- Conditions
- Polyp Colorectal
- Being tested
- absolute diet, normal diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
absolute dietDietary supplement
Patients in absolute diet group were fasted from any food with intravenous infusion of 5% glucose and sodium chloride instead in the first 24 hours. Then, the patients will be given soup for the next 24 hours if there was no delayed complication or discomfort during the fasting. Finally, they will gradually transit from soup to normal diet such as porridge, noodles and rice in the third 24 hours.
normal dietDietary supplement
Patients in normal diet group were directly given normal diet such as porridge, noodles and rice as usual after polypectomy. Meanwhile, all the patients in two groups were given PPI for 3 days intravenously and restricted from vigorous exercise for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Absolute diet | Active comparator | Not described Receives: Dietary Supplement: absolute diet |
| Normal diet | Experimental | Not described Receives: Dietary Supplement: normal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative adverse event rate
Postoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation.
Measured: 14-day after polypectomy
Secondary outcomes (2)
length of stay
calculated by subtracting day of admission from day of discharge.
Measured: 14-day after polypectomy
hospitalization cost
represent the hospital's costs of patients at the hospital
Measured: 14-day after polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start15 Jun 2019 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion20 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp ColorectalStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989791
- Sponsor's protocol ID
- NFEC-2017-080
- Status last verified
- Jun 2019
- First submitted
- 9 Jun 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03989791
- Acronym / sponsor ID
- NFEC-2017-080
- Conditions
- Polyp Colorectal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 20 Jul 2021 (estimated)
- First posted
- 18 Jun 2019 (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.
There is no evidence to prove the impact of post-procedural diet on post-polypectomy bleeding (PPB) or delayed perforation. No relevant study has been conducted and it is yet to be determined if absolute diet is necessary for post-polypectomy patients, and the comparison between normal diet and absolute diet also remains unclear. Therefore, we carried out this randomized controlled study to evaluate and compare tthe clinical effect of different diets on post-polypectomy patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absolute diet | Active comparator | Dietary Supplement: absolute diet |
| Normal diet | Experimental | Dietary Supplement: normal diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 patient with initial diagnosis of colorectal polyp by colonoscopy;
- The maximum size of polyp is more than 20mm;
- The patients underwent single ESD procedure for the polyp and agreed to participate this trial.
Key exclusion criteria (5 listed)
- Uncontrollable hypertension or diabetes；
- Severe comorbidities such as cancer and organ failure etc；
- Patients who were pregnant;
- Patients had anticoagulants during perioperative period;
- Patients with poor compliance. -
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 |
|---|---|---|
| absolute dietPatients in absolute diet group were fasted from any food with intravenous infusion of 5% glucose and sodium chloride instead in the first 24 hours. Then, the patients will be given soup for the next 24 hours if there was no delayed complication or discomfort during the fasting. Finally, they will gradually transit from soup to normal diet such as porridge, noodles and rice in the third 24 hours. | Dietary supplement | Absolute diet |
| normal dietPatients in normal diet group were directly given normal diet such as porridge, noodles and rice as usual after polypectomy. Meanwhile, all the patients in two groups were given PPI for 3 days intravenously and restricted from vigorous exercise for 14 days. | Dietary supplement | Normal diet |
Primary outcome
postoperative adverse event rate
Time frame: 14-day after polypectomy
Postoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation.
2 secondary outcomes
length of stay
Time frame: 14-day after polypectomy
hospitalization cost
Time frame: 14-day after polypectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing absolute diet and normal diet in people with Polyp Colorectal, run by Nanfang Hospital, Southern Medical University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
postoperative adverse event rate (time frame: 14-day after polypectomy). 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 Jun 2019.