The Incidence, Risk Factors, and Effects of Constipation in Critical Patients

Constipation Clinical Trial

Official title:

The Incidence, Risk Factors, and Effects of Constipation in Critical Patients: An Observational Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05683743
• Other study ID #: BAIBU-HEM-AAY-001
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Constipation

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