Should Colon or Non-colon Originated Lesions be Distinguished?

October 18, 2016 updated by: Juanhong Shen, Chinese Medical Association

Acute Lower Gastrointestinal Dysfunction in Critical Care Patients: Should Colon or Non-colon Originated Lesions be Distinguished?

This prospective study was designed to compare the difference of effects of conventional treatment, medicine intervention, endoscopic therapy, and surgery between colon originated and non-colon originated ALGID in critical patients, in order to alert doctors to differ the treatment of the two ALGID and provide basis for treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 2
  • Phase 1

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jinling Hospital
        • Contact:

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:

  1. Patients in our ICU aged 18-75 years.
  2. Patients with a confirmed diagnosis of ALGID.

Exclusion Criteria:

  1. mechanical intestinal obstruction (including tumor, stercoral obstruction etc.)
  2. gastrointestinal hemorrhage within 72 hours.
  3. history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or radiation enteritis.
  4. pregnancy.
  5. contraindications of neostigmine administration.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colon originated
A history of colon (-innervating) nerve damage, moderate or more severe edema; and without a history of colon (-innervating) nerve damage, with mild or severe edema of colonic wall on CT.
Other: Colon originated: Neostigmin, Colonoscopy decompression, Surgery
Active Comparator: Non-colon originated

NCOG met one of the two following criteria:

  1. History of nerve damage that could affect colon movement (colon [-innervating] nerve damage), such as pelvic or retroperitoneal operation, spine injury, or cerebral lesion; and non-existing or mild edema of colonic wall on abdominal CT;
  2. Absence of history of colon(-innervating) nerve damage, with no obvious change in the colonic wall visible on the CT scan.
Other: Non-colon originated: Neostigmin, Colonoscopy decompression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28-day mortality after admission
Time Frame: 1-28 day after admission
1-28 day after admission
ICU mortality, n (%)
Time Frame: 1-28 day after ICU admission
1-28 day after ICU admission

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU stage, (day)
Time Frame: 1-60 day after ICU admission
1-60 day after ICU admission
Hospitalization, (day)
Time Frame: 1-60 day after admission
1-60 day after admission
intra-abdominal pressure
Time Frame: 1-28 day after admission
1-28 day after admission
Abdominal compartment syndrome
Time Frame: 1-28 day after admission
1-28 day after admission

Collaborators and Investigators

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

Sponsor

Chinese Medical Association

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

July 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Jinling37ICUZCY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Acute Lower Gastrointestinal Dysfunction

Clinical Trials on Colon originated: Neostigmin, Colonoscopy decompression, Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe