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

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 Overview

• Status: Unknown
• Conditions: Polyp Colorectal
• Intervention / Treatment: Dietary supplement: absolute diet; Dietary supplement: normal diet

• Study Type: Interventional
• Enrollment (Anticipated): 406
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-75 patient with initial diagnosis of colorectal polyp by colonoscopy;
2. The maximum size of polyp is more than 20mm;
3. The patients underwent single ESD procedure for the polyp and agreed to participate this trial.

Exclusion Criteria:

1. Uncontrollable hypertension or diabetes；
2. Severe comorbidities such as cancer and organ failure etc；
3. Patients who were pregnant;
4. Patients had anticoagulants during perioperative period;
5. Patients with poor compliance. -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Absolute diet	Dietary supplement: absolute diet; 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.
Experimental: Normal diet	Dietary supplement: normal diet; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2019
• Primary Completion (Anticipated): June 15, 2021
• Study Completion (Anticipated): July 20, 2021

Study Registration Dates

• First Submitted: June 9, 2019
• First Submitted That Met QC Criteria: June 16, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 16, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2017-080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No