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

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466903
• Other study ID #: Yan2020-204
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Huihui Yan, PhD&MD
• Phone: +8613575770997
• Email: yandoublehui[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Gastrointestinal Hemorrhage
• Hemorrhage
• Polyps

Intervention

Dietary Supplement:
• Early diet opening
Effects of early dietary recovery after colon polypectomy and colonoscopic mucosal resection on postoperative hemorrhage in patients

Locations

Country	Name	City	State
China	Department of Gastroenterology, the 2nd Affiliated Hospital of Medical College, Zhejiang University	Hangzhou	Zhe Jiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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