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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

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.

Condition or disease Intervention/treatment Phase
Acute Lower Gastrointestinal Dysfunction Other: Colon originated: Neostigmin, Colonoscopy decompression, Surgery Other: Non-colon originated: Neostigmin, Colonoscopy decompression Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Lower Gastrointestinal Dysfunction in Critical Care Patients: Should Colon or Non-colon Originated Lesions be Distinguished?
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

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



Primary Outcome Measures :
  1. 28-day mortality after admission [ Time Frame: 1-28 day after admission ]
  2. ICU mortality, n (%) [ Time Frame: 1-28 day after ICU admission ]

Secondary Outcome Measures :
  1. ICU stage, (day) [ Time Frame: 1-60 day after ICU admission ]
  2. Hospitalization, (day) [ Time Frame: 1-60 day after admission ]
  3. intra-abdominal pressure [ Time Frame: 1-28 day after admission ]
  4. Abdominal compartment syndrome [ Time Frame: 1-28 day after admission ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939508


Contacts
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Contact: Chenyan Zhao, M.D emmazcy@163.com

Locations
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China, Jiangsu
Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Chenyan Zhao, M.D       emmazcy@163.com   
Sponsors and Collaborators
Chinese Medical Association

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Responsible Party: Juanhong Shen, Director, PhD, Principal Investigator, Resident Physician, Chinese Medical Association
ClinicalTrials.gov Identifier: NCT02939508     History of Changes
Other Study ID Numbers: Jinling37ICUZCY
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Juanhong Shen, Chinese Medical Association:
Acute lower gastrointestinal dysfunction
Colon-originated lesions
Critical patient
Colonoscopic decompression
Anticholinergic drugs