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Should Colon or Non-colon Originated Lesions be Distinguished?

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ClinicalTrials.gov Identifier: NCT02939508
Recruitment Status : Unknown
Verified October 2016 by Juanhong Shen, Chinese Medical Association.
Recruitment status was:  Recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Juanhong Shen, Chinese Medical Association

Tracking Information
First Submitted Date  ICMJE October 7, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date October 20, 2016
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • 28-day mortality after admission [ Time Frame: 1-28 day after admission ]
  • ICU mortality, n (%) [ Time Frame: 1-28 day after ICU admission ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • ICU stage, (day) [ Time Frame: 1-60 day after ICU admission ]
  • Hospitalization, (day) [ Time Frame: 1-60 day after admission ]
  • intra-abdominal pressure [ Time Frame: 1-28 day after admission ]
  • Abdominal compartment syndrome [ Time Frame: 1-28 day after admission ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Should Colon or Non-colon Originated Lesions be Distinguished?
Official Title  ICMJE Acute Lower Gastrointestinal Dysfunction in Critical Care Patients: Should Colon or Non-colon Originated Lesions be Distinguished?
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lower Gastrointestinal Dysfunction
Intervention  ICMJE
  • Other: Colon originated: Neostigmin, Colonoscopy decompression, Surgery
  • Other: Non-colon originated: Neostigmin, Colonoscopy decompression
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: Non-colon originated: Neostigmin, Colonoscopy decompression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
158
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939508
Other Study ID Numbers  ICMJE Jinling37ICUZCY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Juanhong Shen, Chinese Medical Association
Study Sponsor  ICMJE Chinese Medical Association
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese Medical Association
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP