Should Colon or Non-colon Originated Lesions be Distinguished?

Sponsor

Chinese Medical Association (Other)

Overall Status

Unknown status

CT.gov ID

NCT02939508

Collaborator

(none)

158

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

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: 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

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: 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

Outcome Measures

Primary Outcome Measures

28-day mortality after admission [1-28 day after admission]
ICU mortality, n (%) [1-28 day after ICU admission]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinling Hospital	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

Chinese Medical Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Juanhong Shen, Director, PhD, Principal Investigator, Resident Physician, Chinese Medical Association

ClinicalTrials.gov Identifier:

NCT02939508

Other Study ID Numbers:

Jinling37ICUZCY

First Posted:

Oct 20, 2016

Last Update Posted:

Oct 20, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Juanhong Shen, Director, PhD, Principal Investigator, Resident Physician, Chinese Medical Association

Acute lower gastrointestinal dysfunction

Colon-originated lesions

Critical patient

Colonoscopic decompression

Anticholinergic drugs

Study Results

No Results Posted as of Oct 20, 2016