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

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Zhejiang University

Status

Enrolling

Conditions

Colonic Polyp

Treatments

Dietary Supplement: Early diet opening

Study type

Interventional

Funder types

Other

Identifiers

NCT05466903
Yan2020-204

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

Control arm
No Intervention group
Description:
patients were given a liquid diet 6 hours after the operation
Experimental arm
Experimental group
Description:
patients were given a liquid diet 2 hours after the operation
Treatment:
Dietary Supplement: Early diet opening

Trial contacts and locations

1

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Central trial contact

Huihui Yan, PhD&MD

Data sourced from clinicaltrials.gov

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