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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05683743
Other study ID # BAIBU-HEM-AAY-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date July 22, 2019

Study information

Verified date December 2022
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aimed to investigate the early, late, and total constipation frequency, related factors, and their effects on the hospitalization day, gastric residual volume, vomiting, distension, and diarrhea, the feeding type, white blood cells, and C-Reactive Protein levels, and body temperature.


Description:

Constipation is one of the most encountered nursing problems in intensive care unit patients. Constipation is an important issue, especially in intensive care patients, requiring careful discussion since it has negative effects as well as high incidence and excessive risk factors. Furthermore, untreated constipation in these patients delays enteral feeding prolonging the time of weaning from the mechanical ventilator, which consequently increases the duration of stay in the intensive care unit. Additionally, it involves complications such as distention, nausea-vomiting, an increase in bacterial infection rate, high morbidity, and mortality. Therefore, the definitions, risks, and effects of constipation, especially early and late constipation, in critically ill patients should be determined for evidence-based interventions. However, studies on the subject are limited.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date July 22, 2019
Est. primary completion date May 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 years - Not abdominal surgery - Not stoma - Not constipation during admission - Not intraperitoneal infection - Not had a recent colonoscopy -> 5 hospitalization days Exclusion Criteria: - Having prolonged constipation and complications (such as decreased bowel sounds, and excessive distension) - Order for regular laxatives or enemas - Not meet inclusion criteria during follow-up

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Bolu Izzet Baysal State Hospital, Anesthesia Intensive Care Unit Bolu Merkez

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The frequency of total constipation, early-type constipation and late-type constipation During the study, patients in the intensive care unit with no bowel movements for four days were accepted as constipated. The ones without defecation for five days were evaluated in the early type constipation group, while the patients without defecation for six days or more were evaluated in the late-type constipation group. Through study completion, an average of five months
Secondary he duration of stay in the intensive care unit the duration of stay in the intensive care unit as days (how many days?) Through study completion, an average of five months
Secondary the amount of gastric residual volume the amount of gastric residual volume in ml/cc Through study completion, an avarage of five months
Secondary developing vomiting developing vomiting as numbers (how many times?) Through study completion, an average of five months
Secondary Level of white blood cells level of white blood cells (WBC) in mcL Through study completion, an average of five months
Secondary body temperature body temperature in celsius Through study completion, an average of five months
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