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

Not Applicable

• Conditions: Polyp Colorectal
• Interventions: Dietary Supplement: normal diet; Dietary Supplement: absolute diet

• Registration Number: NCT03989791
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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 remains unclear. Therefore, we carried out this randomized controlled study to evaluate and compare tthe clinical effect of different diets on post-polypectomy patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-09
• Study Start: 2019-06-15
• Study First Submitted QC: 2019-06-16
• Last Update Submitted: 2019-06-16
• Study First Posted: 2019-06-18
• Last Update Posted: 2019-06-18
• Primary Completion: 2021-06-15
• Study Completion: 2021-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 406

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal diet	normal diet	-
Absolute diet	absolute diet	-

Primary Outcome Measures

Name	Time	Method
postoperative adverse event rate	14-day after polypectomy	Postoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation.

Secondary Outcome Measures

Name	Time	Method
length of stay	14-day after polypectomy	calculated by subtracting day of admission from day of discharge.
hospitalization cost	14-day after polypectomy	represent the hospital's costs of patients at the hospital