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

NCT05800886 | Completed

• 1 other identifier: GaziU-SBF-BI-1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholelithiases; Nursing Caries; Perioperative Complication; Bowel Ileus

Keywords

Laparoscopic cholecystectomy; Early mobilization; Tea; Coffee; Water consumption; Intestines; Nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mobilization time

  up to 24 hours after surgery

• First defecation time

  up to 24 hours after surgery

• Bowel movements

  up to 8 hours after surgery

• Length of stay in hospital

  average of 2 days

Study Arms (4)

Tea Group

EXPERIMENTAL

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

Coffee Group

EXPERIMENTAL

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

Warm Water Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Early mobilization and tea consumption OTHER

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.

Tea Group

Early mobilization and coffee consumption OTHER

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.

Coffee Group

Early mobilization and warm water consumption OTHER

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.

Warm Water Group

Ongoing treatment OTHER

The first mobilization and oral intake of the patients in the control group started at the 8th hour.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholelithiasis; Ileus

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: April 6, 2023
• Study Start: January 1, 2020
• Primary Completion: August 25, 2021
• Study Completion: September 15, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)