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

Polyp Colorectal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03989791
• Other study ID #: NFEC-2017-080
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: July 20, 2021

Study information

• Verified date: June 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 406
• Est. completion date: July 20, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Polyp Colorectal

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative adverse event rate	Postoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation.	14-day after polypectomy
Secondary	length of stay	calculated by subtracting day of admission from day of discharge.	14-day after polypectomy
Secondary	hospitalization cost	represent the hospital's costs of patients at the hospital	14-day after polypectomy