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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05466903

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp	Dietary Supplement: Early diet opening	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control arm patients were given a liquid diet 6 hours after the operation
Experimental: Experimental arm patients were given a liquid diet 2 hours after the operation	Dietary Supplement: Early diet opening Effects of early dietary recovery after colon polypectomy and colonoscopic mucosal resection on postoperative hemorrhage in patients

Arm

Intervention/Treatment

No Intervention: Control arm

patients were given a liquid diet 6 hours after the operation

Experimental: Experimental arm

patients were given a liquid diet 2 hours after the operation

Dietary Supplement: Early diet opening

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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