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

NCT05683743 | Completed

• 1 other identifier: BAIBU-HEM-AAY-001
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation

Keywords

Critical care; Constipation; Intensive care; Nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• he duration of stay in the intensive care unit

  Through study completion, an average of five months

• the amount of gastric residual volume

  Through study completion, an avarage of five months

• developing vomiting

  Through study completion, an average of five months

• Level of white blood cells

  Through study completion, an average of five months

• body temperature

  Through study completion, an average of five months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The data were collected from the Anesthesia and Reanimation Intensive Care Unit in a state hospital of Bolu in 2019. To determine the number of observations in our study, a pilot study was conducted with 20 patients. These patients were also included in the main study. The constipation rate in the intensive care unit was determined as 67% in the pilot study. Considering this ratio, the sample size was calculated using the PASS 11 program. Accordingly, at least 86 patients had to be included in the study keeping a 95% probability and 10% deviation. The sample consisted of 116 patients who were reachable during the study, met the inclusion criteria, and volunteered to participate in the study.

You may qualify if:

• \>18 years
• Not abdominal surgery
• Not stoma
• Not constipation during admission
• Not intraperitoneal infection
• Not had a recent colonoscopy -\> 5 hospitalization days

You may not qualify if:

• Having prolonged constipation and complications (such as decreased bowel sounds, and excessive distension)
• Order for regular laxatives or enemas

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Izzet Baysal State Hospital, Anesthesia Intensive Care Unit

Bolu, Merkez, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arzu AKMAN YILMAZ, RN, PhD.

  Bolu Izzet Baysal University

  PRINCIPAL INVESTIGATOR

• Seyma OZDEMIR, RN,MSN.

  Pursaklar State Hospital

  PRINCIPAL INVESTIGATOR

• Esra OZDEMIR, MD.

  Bolu Izzet Baysal State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 13, 2023
• Study Start: December 1, 2018
• Primary Completion: May 5, 2019
• Study Completion: July 22, 2019
• Last Updated: January 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)