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Status unknownNCT05466903Updated Jul 20, 2022

Prospective, Randomized, Parallel Clinical Controlled Study of Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps

An interventional study of Early diet opening in Colonic Polyp, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jul 2020, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Currently, hemorrhage remains the most common postoperative complication in patients with colon polyps, with an incidence of approximately 1.5%. The main reasons for postoperative hemorrhage are: the patient's own condition, the nature of the polyp and the operation. The number of patients treated for colon polyps has increased, postoperative care is confusing, medical resources are wasted, and the time span for postoperative diet recovery is large. However, studies on the effect of postoperative dietary recovery timing on postoperative polyp bleeding are rare.

02

Conditions studied

  • Colonic Polyp

Keywords

  • Colonic Polyp
  • Gastrointestinal Hemorrhage
03

In context

Colonic Polyps

326 studies on the registry are indexed under Colonic Polyps; 53 are open to participants now.

This study's planned enrollment of 200 is below the median of 264 across 221 interventional studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-75, no gender restrictions,
  • Patients with colonic polyps identified by colonoscopy and requiring endoscopic treatment,
  • Polyp size 0.5cm-2cm,
  • Patients agreed to enroll and signed a written informed consent,
  • Adherence is good and agrees to be treated and evaluated as required by the study protocol.

Exclusion criteria

Exclusion Criteria:

  • Patients with contraindications to endoscopic treatment of colonic polyps, including platelets ≤50×109/L, prothrombin time prolonged by 4 seconds or more, and INR≥2.0,
  • Patients with severe heart, brain, lung, blood system diseases, uremia, connective tissue disease,
  • Patients requiring treatment with NSAIDs, aspirin, glucocorticoids, or clopidogrel within the first 7 days of the study,
  • During the course of the study, due to other concomitant/complications, patients who need to use drugs that affect the efficacy of the trial, including various anticoagulants, antiplatelet drugs and hemostatic drugs,
  • Alcoholics, drug addicts or those with uncontrollable neuropsychiatric diseases and others who are not suitable for participating in the trial,
  • Pregnant, breastfeeding women, or women in childbearing age who wish to become pregnant,
  • Patients with malignant tumor of digestive system,
  • Other circumstances in which the investigator believes that the patient should not participate in this trial
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • No intervention
    Control arm

    patients were given a liquid diet 6 hours after the operation

  • Experimental
    Experimental arm

    patients were given a liquid diet 2 hours after the operation

    Dietary Supplement: Early diet opening

Interventions

  • Dietary supplementEarly diet opening

    Effects of early dietary recovery after colon polypectomy and colonoscopic mucosal resection on postoperative hemorrhage in patients

06

What researchers measure

Primary outcomes

  1. Postoperative bloody stool

    Postoperative massive hemorrhage: if the amount of blood in stool exceeds 400ml within 1 hour to 14 days after operation, or the hemoglobin decreases \>2g/dl Ordinary hemorrhage: the amount of blood in stool does not meet the above standards

    Time frame: up to 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Gastroenterology, the 2nd Affiliated Hospital of Medical College, Zhejiang University
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05466903
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Responsible party
Sponsor
First posted
Jul 20, 2022
Start date
Jul 1, 2020
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Jul 20, 2022

Study contacts

Huihui Yan, PhD&MD
Contact
yandoublehui@zju.edu.cn
+8613575770997

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Second Affiliated Hospital, Zhejiang University, School of Medicine

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