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

Not Applicable

Completed

• Conditions: Bowel Ileus; Cholelithiases; Nursing Caries; Perioperative Complication
• Interventions: Other: Early mobilization and warm water consumption; Other: Ongoing treatment; Other: Early mobilization and tea consumption; Other: Early mobilization and coffee consumption

• Registration Number: NCT05800886
• Lead Sponsor: Gazi University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-08-25
• Study Completion: 2021-09-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm Water Group	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 within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.
Control Group	Ongoing treatment	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.
Tea Group	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 within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.
Coffee Group	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 within 15 minutes. Patients were supported by the investigator for early mobilization from the 4th hour after surgery.

Primary Outcome Measures

Name	Time	Method
First flatus time	up to 24 hours after surgery	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

Name	Time	Method
Mobilization time	up to 24 hours after surgery	The duration of mobilization for the first 24 hours after surgery were evaluated with Patient Mobilization Follow-up Form.
First defecation time	up to 24 hours after surgery	The patient's first defecation time was questioned. The hour reported by the patient was evaluated as the time of first defecation.
Bowel movements	up to 8 hours after surgery	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	average of 2 days	the length of hospital stay (throughout their hospital stay, average of 2 days)

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey