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Completed

NCT Number: NCT05683743

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolu Izzet Baysal State Hospital, Anesthesia Intensive Care Unit

Bolu, Merkez, 14030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The frequency of total constipation, early-type constipation and late-type constipation

    Time frame: Through study completion, an average of five months

    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.

Secondary outcomes

  1. he duration of stay in the intensive care unit

    Time frame: Through study completion, an average of five months

    the duration of stay in the intensive care unit as days (how many days?)

  2. the amount of gastric residual volume

    Time frame: Through study completion, an avarage of five months

    the amount of gastric residual volume in ml/cc

  3. developing vomiting

    Time frame: Through study completion, an average of five months

    developing vomiting as numbers (how many times?)

  4. Level of white blood cells

    Time frame: Through study completion, an average of five months

    level of white blood cells (WBC) in mcL

  5. body temperature

    Time frame: Through study completion, an average of five months

    body temperature in celsius

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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