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

Nursing Caries Clinical Trial

Official title:

The Effect of Early Mobilization With Tea, Coffee and Warm Water Consumption on Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800886
• Other study ID #: GaziU-SBF-BI-1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: March 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 15, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Ileus
• Cholecystolithiasis
• Cholelithiases
• Cholelithiasis
• Gallstones
• Nursing Caries
• Perioperative Complication

Intervention

Other:
• 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 (instant 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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 24 hours after surgery
Secondary	Mobilization time	The duration of mobilization for the first 24 hours after surgery were evaluated with Patient Mobilization Follow-up Form.	up to 24 hours after surgery
Secondary	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.	up to 24 hours after surgery
Secondary	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.	up to 8 hours after surgery
Secondary	Length of stay in hospital	the length of hospital stay (throughout their hospital stay, average of 2 days)	average of 2 days