The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial

Conditions
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Polyp Colorectal

Intervention / Treatment
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* Dietary Supplement: absolute diet
* Dietary Supplement: normal diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Absolute diet<br> | Dietary Supplement: absolute diet<br>* 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.<br>|
| Experimental: Normal diet<br> | Dietary Supplement: normal diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative adverse event rate | Postoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation. | 14-day after polypectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay | calculated by subtracting day of admission from day of discharge. | 14-day after polypectomy | 
| hospitalization cost | represent the hospital's costs of patients at the hospital | 14-day after polypectomy |