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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Polyp Colorectal

Treatments: Dietary Supplement: normal diet; Dietary Supplement: absolute diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03989791

NFEC-2017-080

Details and patient eligibility

About

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.

Enrollment: 406 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

Absolute diet

Active Comparator group

Treatment:

Dietary Supplement: absolute diet

Normal diet

Experimental group

Treatment:

Dietary Supplement: normal diet