Should Colon or Non-colon Originated Lesions be Distinguished?

Chinese Medical Association

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Lower Gastrointestinal Dysfunction

Treatments: Other: Colon originated: Neostigmin, Colonoscopy decompression, Surgery; Other: Non-colon originated: Neostigmin, Colonoscopy decompression

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02939508

Jinling37ICUZCY

Details and patient eligibility

About

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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Colon originated

Experimental group

Description:

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.

Treatment:

Other: Colon originated: Neostigmin, Colonoscopy decompression, Surgery

Non-colon originated

Active Comparator group

Description:

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.

Treatment:

Other: Non-colon originated: Neostigmin, Colonoscopy decompression