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

Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05466903
Enrollment
200
Registered
2022-07-20
Start date
2020-07-01
Completion date
2022-12-30
Last updated
2022-07-20

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

Conditions

Colonic Polyp

Keywords

Colonic Polyp, Gastrointestinal Hemorrhage

Brief 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.

Interventions

DIETARY_SUPPLEMENTEarly diet opening

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative bloody stoolup to 2 weeksPostoperative 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

Countries

China

Contacts

Primary ContactHuihui Yan, PhD&MD
yandoublehui@zju.edu.cn+8613575770997

Outcome results

None listed

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