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NCT Number: NCT05800886

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

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.

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Key information

Conditions

Cholelithiases Biliary Tract Diseases Bowel Ileus Cholelithiasis Digestive System Diseases Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction Nursing Caries Perioperative Complication

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Ongoing treatment

Other

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

Primary outcomes

  1. First flatus time

    Time frame: 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 outcomes

  1. Mobilization time

    Time frame: 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.

  2. First defecation time

    Time frame: 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.

  3. Bowel movements

    Time frame: 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.

  4. Length of stay in hospital

    Time frame: average of 2 days

    the length of hospital stay (throughout their hospital stay, average of 2 days)

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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