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

NCT ID: NCT05466903

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-12-30

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.

Conditions

Colonic Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control arm

patients were given a liquid diet 6 hours after the operation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental arm

patients were given a liquid diet 2 hours after the operation

Group Type: EXPERIMENTAL

Early diet opening

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Early diet opening

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Gastroenterology, the 2nd Affiliated Hospital of Medical College, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huihui Yan, PhD&MD

Role: CONTACT

yandoublehui@zju.edu.cn

+8613575770997

Facility Contacts

Xinliang Lu, PhD&MD

Role: primary

lux@zju.edu.cn

+8613600515015

Other Identifiers

Yan2020-204

Identifier Type: -

Identifier Source: org_study_id