NCT06596421

Brief Summary

Background and Aim: Although the incidence of gastrointestinal complications after cardiovascular surgery is reported to be rare, it has been reported that patients experience problems with constipation within the week after discharge. The presence of abdominal distension due to constipation after cardiac surgery may lead to prolonged wound healing, paralytic ileus and gastric dilatation. This study aimed to evaluate the effect of abdominal massage on constipation after cardiac surgery. Methods: A prospective, randomised controlled quasi-experimental study was conducted in the cardiovascular surgery clinic of a public hospital between September 2022 and July 2023. A power analysis was performed to determine the sample size. A total of 130 patients were randomly assigned to the experimental or control group using a simple randomisation method. Data were collected using a 21-item form from the first day after surgery. Burping and defecation times of the patients were evaluated and recorded. Results: The mean age of the experimental group was 55.2±13.3 years, while the mean age of the control group was 60.4±10.6 years (p=0.015). There was no statistically significant difference between the groups in terms of sociodemographic characteristics, bowel preparation and preoperative fasting times. It was observed that bowel sounds started earlier in the experimental group (70.8% on the first postoperative day) compared to the control group (46.2% on the first postoperative day) (X2=16.629; p=0.005). The first burping time measurements in the control group (x̄=46.415 hours) were higher than those in the experimental group (x̄=31.262 hours). Postoperative defecation time was longer in the control group (x̄=99.51 hours) than in the experimental group (x̄=61.611 hours).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

August 30, 2024

Last Update Submit

September 11, 2024

Conditions

Keywords

Cardiac surgeryabdominal massageconstipation

Outcome Measures

Primary Outcomes (1)

  • patient sociodemographic characteristics and physical measurements form

    It was noted how many hours after the operation he had intestinal gas.

    2 days to 1 week

Study Arms (2)

experiment

EXPERIMENTAL

abdominal massage

Other: abdominal massage

control

NO INTERVENTION

no intervention

Interventions

abdominal massage

experiment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Being older than 18 years
  • Agreeing to participate in the study
  • Undergoing a cardiac surgery
  • Not having a barrier for communication
  • Not having a mental or cognitive disability
  • Not using constipation treatment (like laxatives or enemas)
  • Having no history of constipation disorders or gastrointestinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir Universty

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Researcher

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 19, 2024

Study Start

October 20, 2022

Primary Completion

May 5, 2024

Study Completion

May 6, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations