Should Colon or Non-colon Originated Lesions be Distinguished?

NCT ID: NCT02939508

Last Updated: 2016-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-08-31

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.

Detailed Description

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Conditions

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Acute Lower Gastrointestinal Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Colon originated: Neostigmin, Colonoscopy decompression, Surgery

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Non-colon originated: Neostigmin, Colonoscopy decompression

Intervention Type OTHER

Interventions

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Colon originated: Neostigmin, Colonoscopy decompression, Surgery

Intervention Type OTHER

Non-colon originated: Neostigmin, Colonoscopy decompression

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role lead

Responsible Party

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Juanhong Shen

Director, PhD, Principal Investigator, Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jinling Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chenyan Zhao, M.D

Role: CONTACT

Facility Contacts

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Chenyan Zhao, M.D

Role: primary

Other Identifiers

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Jinling37ICUZCY

Identifier Type: -

Identifier Source: org_study_id

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