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

NCT03989791 | Unknown

• 1 other identifier: NFEC-2017-080
• Study Type: interventional
• Target: 406
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polyp Colorectal

Outcome Measures

Primary Outcomes (1)

• postoperative adverse event rate

  Postoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation.

  14-day after polypectomy

Secondary Outcomes (2)

• length of stay

  14-day after polypectomy

• hospitalization cost

  14-day after polypectomy

Study Arms (2)

Absolute diet

ACTIVE COMPARATOR

Dietary Supplement: absolute diet

Normal diet

EXPERIMENTAL

Dietary Supplement: normal diet

Interventions

absolute diet DIETARY_SUPPLEMENT

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.

Absolute diet

normal diet DIETARY_SUPPLEMENT

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.

Normal diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: June 18, 2019
• Study Start: June 15, 2019
• Primary Completion: June 15, 2021
• Study Completion: July 20, 2021
• Last Updated: June 18, 2019

Record last verified: 2019-06