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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03989791
Enrollment
406
Registered
2019-06-18
Start date
2019-06-15
Completion date
2021-07-20
Last updated
2019-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyp Colorectal

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.

Interventions

DIETARY_SUPPLEMENTabsolute 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.

DIETARY_SUPPLEMENTnormal 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.

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
postoperative adverse event rate14-day after polypectomyPostoperative AE includes PPB, post polypectomy electrocoagulation syndrome(PPES) and delayed perforation.

Secondary

MeasureTime frameDescription
length of stay14-day after polypectomycalculated by subtracting day of admission from day of discharge.
hospitalization cost14-day after polypectomyrepresent the hospital's costs of patients at the hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026