The Effect of Early Mobilization and Fluid Consumption on Bowel Movements After Cholecystectomy
NCT ID: NCT05800886
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2020-01-01
2021-09-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Tea Group
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.
Early mobilization and tea consumption
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.
Coffee Group
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.
Early mobilization and coffee consumption
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.
Warm Water Group
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.
Early mobilization and warm water consumption
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.
Control Group
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.
Ongoing treatment
The first mobilization and oral intake of the patients in the control group started at the 8th hour.
Interventions
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Early mobilization and tea consumption
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.
Early mobilization and coffee consumption
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.
Early mobilization and warm water consumption
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.
Ongoing treatment
The first mobilization and oral intake of the patients in the control group started at the 8th hour.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Gazi University
OTHER
Responsible Party
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Burçin IRMAK
Principal Investigator
Locations
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Gazi University
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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GaziU-SBF-BI-1
Identifier Type: -
Identifier Source: org_study_id
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