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

Not Applicable

• Conditions: Colonic Polyp
• Interventions: Dietary Supplement: Early diet opening

• Registration Number: NCT05466903
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Early diet opening	patients were given a liquid diet 2 hours after the operation

Primary Outcome Measures

Name	Time	Method
Postoperative bloody stool	up to 2 weeks	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

Trial Locations

Locations (1)

Department of Gastroenterology, the 2nd Affiliated Hospital of Medical College, Zhejiang University; 🇨🇳 Hangzhou, Zhe Jiang, China