Should Colon or Non-colon Originated Lesions be Distinguished?

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Lower Gastrointestinal Dysfunction

Intervention / Treatment
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* Other: Colon originated: Neostigmin, Colonoscopy decompression, Surgery
* Other: Non-colon originated: Neostigmin, Colonoscopy decompression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in our ICU aged 18-75 years. Patients with a confirmed diagnosis of ALGID. Exclusion Criteria: mechanical intestinal obstruction (including tumor, stercoral obstruction etc.) gastrointestinal hemorrhage within 72 hours. history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or radiation enteritis. pregnancy. contraindications of neostigmine administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colon originated<br>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<br> <br> |
| Active Comparator: Non-colon originated<br>NCOG met one of the two following criteria: 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; 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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute lower gastrointestinal dysfunction, Colon-originated lesions, Critical patient, Colonoscopic decompression, Anticholinergic drugs