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

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

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.

Study Overview

• Status: Completed
• Conditions: Nursing Caries; Cholelithiases; Perioperative Complication; Bowel Ileus
• Intervention / Treatment: Other: Early mobilization and tea consumption; Other: Early mobilization and coffee consumption; Other: Early mobilization and warm water consumption; Other: Ongoing treatment

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: Ongoing treatment; The first mobilization and oral intake of the patients in the control group started at the 8th hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Length of stay in hospital	the length of hospital stay (throughout their hospital stay, average of 2 days)	average of 2 days

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Nursing; Laparoscopic cholecystectomy; Early mobilization; Tea; Coffee; Water consumption; Intestines
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: GaziU-SBF-BI-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No