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The Effect of Early Mobilization and Fluid Consumption on Bowel Movements After Cholecystectomy

Primary Purpose

Cholelithiases, Nursing Caries, Perioperative Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Early mobilization and tea consumption
Early mobilization and coffee consumption
Early mobilization and warm water consumption
Ongoing treatment
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholelithiases focused on measuring Laparoscopic cholecystectomy, Early mobilization, Tea, Coffee, Water consumption, Intestines, Nursing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: To agree to participate in the study To be the age is between 18 and 65 years old To undergone laparoscopic cholecystectomy surgery To have American Society of Anesthesiologists (ASA) classification I or II Exclusion Criteria: To have a history of cesarean section, hysterectomy, extensive intra-abdominal surgery To have metastatic disease, inflammatory bowel disease To use drugs that may affect intestinal functions due to systemic diseases To known allergy or sensitivity to coffee/caffeine To having difficulty swallowing To have mental disability or perception problems To have a barrier to communication

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Tea Group

Coffee Group

Warm Water Group

Control Group

Arm Description

At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of tea within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.

At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of coffee within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.

At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of warm water within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.

The first mobilization and oral intake of the patients in the control group started at the 8th hour. Control group didn't receive any intervention. Participants received usual care from health professionals.

Outcomes

Primary Outcome Measures

First flatus time
The patient's first flatus output time was questioned. The hour reported by the patient was evaluated as the time of first flatus.

Secondary Outcome Measures

Mobilization time
The duration of mobilization for the first 24 hours after surgery were evaluated with Patient Mobilization Follow-up Form.
First defecation time
The patient's first defecation time was questioned. The hour reported by the patient was evaluated as the time of first defecation.
Bowel movements
Bowel movements were listened to with the same stethoscope, by dividing the abdomen into four quadrants and evaluating each quadrant. The number of the intestinal sounds in one minute were counted and recorded.
Length of stay in hospital
the length of hospital stay (throughout their hospital stay, average of 2 days)

Full Information

First Posted
March 12, 2023
Last Updated
March 23, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05800886
Brief Title
The Effect of Early Mobilization and Fluid Consumption on Bowel Movements After Cholecystectomy
Official Title
The Effect of Early Mobilization With Tea, Coffee and Warm Water Consumption on Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Objective: The aim of this study was to determine the effect of early mobilization with consumption of tea, coffee, and warm water on bowel movements in patients who had laparoscopic cholecystectomy surgery. Design: The study was a single-center, parallel, randomized, controlled trial. Setting: This study was carried out in the general surgery clinic of a university hospital in Türkiye. Metod: The participants were randomized into four equal groups: tea, coffee, arm water and control. At the 4th hour postoperatively, the patients in the intervention group were first mobilized after drinking 200 ml of tea, coffee or warm water within 15 minutes. The first mobilization and oral intake of the patients in the control group started at the 8th hour. Bowel movements, mobilization time, first flatulence, first stool removal and hospital stay of the patients were followed up. Data were collected with "Patient Information Form", "Glasgow Coma Scale", "Patient Mobilization Follow-up Form" and "Patient Undergone Laparoscopic Cholecystectomy Surgery Follow-Up Form". Hypothesis: H0-a: Early mobilization and tea consumption have no effect on the first flatulence time in patients who have undergone laparoscopic cholecystectomy surgery. H0-b: Early mobilization and coffee consumption have no effect on the first flatulence time in patients who have undergone laparoscopic cholecystectomy. H0-c: Early mobilization and consumption of warm water have no effect on the initial flatulence time in patients who have undergone laparoscopic cholecystectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiases, Nursing Caries, Perioperative Complication, Bowel Ileus
Keywords
Laparoscopic cholecystectomy, Early mobilization, Tea, Coffee, Water consumption, Intestines, Nursing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tea Group
Arm Type
Experimental
Arm Description
At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of tea within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.
Arm Title
Coffee Group
Arm Type
Experimental
Arm Description
At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of coffee within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.
Arm Title
Warm Water Group
Arm Type
Experimental
Arm Description
At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of warm water within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The first mobilization and oral intake of the patients in the control group started at the 8th hour. Control group didn't receive any intervention. Participants received usual care from health professionals.
Intervention Type
Other
Intervention Name(s)
Early mobilization and tea consumption
Intervention Description
At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of tea (black tea 2 g, caffeine amount: 45-55 mg/150 ml) within 15 minutes. A thermos cup is used to prevent the heat loss of the beverage. Patients were supported by the investigator for early mobilization from the 4th hour after surgery. After the surgery, the first mobilization of the patients is in the form of walking in the patient room of 10 meters (5 meters going and 5 meters returning). According to Enhanced Recovery After Surgery protocols, it is aimed for the patient to walk for at least 2 hours after surgery.
Intervention Type
Other
Intervention Name(s)
Early mobilization and coffee consumption
Intervention Description
At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of coffee (ınstant coffee 2 g, caffeine amount: 60/80 mg/150 ml) within 15 minutes. A thermos cup is used to prevent the heat loss of the beverage. Patients were supported by the investigator for early mobilization from the 4th hour after surgery. After the surgery, the first mobilization of the patients is in the form of walking in the patient room of 10 meters (5 meters going and 5 meters returning). According to Enhanced Recovery After Surgery protocols, it is aimed for the patient to walk for at least 2 hours after surgery.
Intervention Type
Other
Intervention Name(s)
Early mobilization and warm water consumption
Intervention Description
At the 4th hour postoperatively, the patients in the tea group were first mobilized after drinking 200 ml of warm water (37 centigrade) within 15 minutes. A thermos cup is used to prevent the heat loss of the beverage. Patients were supported by the investigator for early mobilization from the 4th hour after surgery. After the surgery, the first mobilization of the patients is in the form of walking in the patient room of 10 meters (5 meters going and 5 meters returning). According to Enhanced Recovery After Surgery protocols, it is aimed for the patient to walk for at least 2 hours after surgery.
Intervention Type
Other
Intervention Name(s)
Ongoing treatment
Intervention Description
The first mobilization and oral intake of the patients in the control group started at the 8th hour.
Primary Outcome Measure Information:
Title
First flatus time
Description
The patient's first flatus output time was questioned. The hour reported by the patient was evaluated as the time of first flatus.
Time Frame
up to 24 hours after surgery
Secondary Outcome Measure Information:
Title
Mobilization time
Description
The duration of mobilization for the first 24 hours after surgery were evaluated with Patient Mobilization Follow-up Form.
Time Frame
up to 24 hours after surgery
Title
First defecation time
Description
The patient's first defecation time was questioned. The hour reported by the patient was evaluated as the time of first defecation.
Time Frame
up to 24 hours after surgery
Title
Bowel movements
Description
Bowel movements were listened to with the same stethoscope, by dividing the abdomen into four quadrants and evaluating each quadrant. The number of the intestinal sounds in one minute were counted and recorded.
Time Frame
up to 8 hours after surgery
Title
Length of stay in hospital
Description
the length of hospital stay (throughout their hospital stay, average of 2 days)
Time Frame
average of 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To agree to participate in the study To be the age is between 18 and 65 years old To undergone laparoscopic cholecystectomy surgery To have American Society of Anesthesiologists (ASA) classification I or II Exclusion Criteria: To have a history of cesarean section, hysterectomy, extensive intra-abdominal surgery To have metastatic disease, inflammatory bowel disease To use drugs that may affect intestinal functions due to systemic diseases To known allergy or sensitivity to coffee/caffeine To having difficulty swallowing To have mental disability or perception problems To have a barrier to communication
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Early Mobilization and Fluid Consumption on Bowel Movements After Cholecystectomy

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