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

July 18, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhe Jiang
      • Hangzhou, Zhe Jiang, China, 310000
        • Recruiting
        • Department of Gastroenterology, the 2nd Affiliated Hospital of Medical College, Zhejiang University
        • Contact:
          • Xinliang Lu, PhD&MD
          • Phone Number: +8613600515015
          • Email: lux@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative bloody stool
Time Frame: 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
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yan2020-204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe