CholelithiasesNCT05800886

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

A study testing Early mobilization and tea consumption, Early mobilization and coffee consumption and Early mobilization and warm water consumption in people with Cholelithiases and Nursing Caries, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cholelithiases, Nursing Caries, Perioperative Complication
What is being tested?: Early mobilization and tea consumption, Early mobilization and coffee consumption and Early mobilization and warm water consumption
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2020to 15 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Gazi University
Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Early Mobilization With Tea, Coffee and Warm Water Consumption on Bowel Movements in Patients Undergoing 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
Being tested: Early mobilization and tea consumption, Early mobilization and coffee consumption, Early mobilization and warm water consumption, Ongoing treatment
Keywords: Laparoscopic cholecystectomy, Early mobilization, Tea, Coffee, Water consumption, Intestines, Nursing
Medical subject headings: Cholelithiasis, Ileus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05800886
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Ongoing treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 24 hours after surgery

Secondary outcomes (4)

Mobilization time
The duration of mobilization for the first 24 hours after surgery were evaluated with Patient Mobilization Follow-up Form.
Measured: 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.
Measured: 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.
Measured: up to 8 hours after surgery
Length of stay in hospital
the length of hospital stay (throughout their hospital stay, average of 2 days)
Measured: average of 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202015 Sep 2021

First posted6 Apr 2023
Study start1 Jan 2020
Primary completion25 Aug 2021
Study completion15 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CholelithiasesStudies of the same condition, open and under way.
More trials run by Gazi UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05800886
Sponsor's protocol ID: GaziU-SBF-BI-1
Status last verified: Mar 2023
First submitted: 12 Mar 2023
Last updated: 6 Apr 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis

All Cholelithiases trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Early Mobilization With Tea, Coffee and Warm Water Consumption on Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy Surgery
ClinicalTrials.gov ID: NCT05800886
Acronym / sponsor ID: GaziU-SBF-BI-1
Conditions: Cholelithiases, Nursing Caries, Perioperative Complication, Bowel Ileus
Keywords: Laparoscopic cholecystectomy, Early mobilization, Tea, Coffee, Water consumption, Intestines, Nursing
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Gazi UniversityUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 25 Aug 2021 (actual)
Study completion: 15 Sep 2021 (actual)
First posted: 6 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Tea Group	Experimental	Other: Early mobilization and tea consumptionAt 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	Experimental	Other: Early mobilization and coffee consumptionAt 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.
Warm Water Group	Experimental	Other: Early mobilization and warm water consumptionAt 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	Active comparator	Other: Ongoing treatmentThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early mobilization and tea consumptionAt 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.	Other	Tea Group
Early mobilization and coffee consumptionAt 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.	Other	Coffee Group
Early mobilization and warm water consumptionAt 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.	Other	Warm Water Group
Ongoing treatmentThe first mobilization and oral intake of the patients in the control group started at the 8th hour.	Other	Control Group

Primary outcome

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.

4 secondary outcomes

Mobilization time
Time frame: up to 24 hours after surgery
First defecation time
Time frame: up to 24 hours after surgery
Bowel movements
Time frame: up to 8 hours after surgery
Length of stay in hospital
Time frame: average of 2 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
Individual participant dataSharing planned: No

Related trials for Cholelithiases

Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First flatus time (time frame: up to 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05800886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.