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

NCT05466903 | Unknown

• 1 other identifier: Yan2020-204
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Colonic Polyp; Gastrointestinal Hemorrhage

Outcome Measures

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

  up to 2 weeks

Study Arms (2)

Control arm

NO INTERVENTION

patients were given a liquid diet 6 hours after the operation

Experimental arm

EXPERIMENTAL

patients were given a liquid diet 2 hours after the operation

Dietary Supplement: Early diet opening

Interventions

Early diet opening DIETARY_SUPPLEMENT

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

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes

Central Study Contacts

Huihui Yan, PhD&MD

CONTACT

+8613575770997; yandoublehui@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 20, 2022
• Study Start: July 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

CN (1)