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

Primary Purpose

Colonic Polyp

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early diet opening
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colonic Polyp focused on measuring Colonic Polyp, Gastrointestinal Hemorrhage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Experimental arm

Arm Description

patients were given a liquid diet 6 hours after the operation

patients were given a liquid diet 2 hours after the operation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 11, 2022
Last Updated
July 18, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05466903
Brief Title
Prospective, Randomized, Parallel Clinical Controlled Study of Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps
Official Title
Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
Keywords
Colonic Polyp, Gastrointestinal Hemorrhage

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
patients were given a liquid diet 6 hours after the operation
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
patients were given a liquid diet 2 hours after the operation
Intervention Type
Dietary Supplement
Intervention Name(s)
Early diet opening
Intervention Description
Effects of early dietary recovery after colon polypectomy and colonoscopic mucosal resection on postoperative hemorrhage in patients
Primary Outcome Measure Information:
Title
Postoperative bloody stool
Description
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
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huihui Yan, PhD&MD
Phone
+8613575770997
Email
yandoublehui@zju.edu.cn
Facility Information:
Facility Name
Department of Gastroenterology, the 2nd Affiliated Hospital of Medical College, Zhejiang University
City
Hangzhou
State/Province
Zhe Jiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinliang Lu, PhD&MD
Phone
+8613600515015
Email
lux@zju.edu.cn

12. IPD Sharing Statement

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

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