Gastrointestinal FunctionsNCT06180135
The Effect Of Coffee And Tea Drink On Gis Functions Healing Quality After Surgery in Patients Surgery
A study testing TURKISH COFFEE DRINK and FENNEL TEA DRINK in people with Gastrointestinal Functions, run by Eastern Mediterranean University at 3 sites in Cyprus.
Trial summary
The positive effects of coffee on general health, central nervous system, cardiovascular system and bowel movements in healthy people are known. In a few studies conducted in recent years, it is stated that coffee consumption is a safe and effective method for accelerating bowel movements after surgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Functions
- What is being tested?
- TURKISH COFFEE DRINK and FENNEL TEA DRINK
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesCyprus
- Study dates
- 5 Aug 2023to 20 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone laparoscopic cholecystectomy under general anesthesia
- Patients whose bowel functions do not have all chronic or metabolic features,
- Patients without auditory, mental and past diseases
- Patients who volunteered for the study
Who cannot join
- Patients who did not receive general anesthesia and did not have laparoscopic cholecystectomy surgery
- Those who have any chronic or metabolic disease that will affect intestinal functions,
- Those with auditory, mental and neurological diseases,
- Patients using drugs for psychiatric disorders,
- who are not willing to participate in the research,
- Patients who are intubated and sedated,
- Those with stoma
- Patients with previous abdominal surgery will not be included in the study.
Trial locations and contacts
3 sites in 1 country.
Cyprus3 sites
Gazimağusa Devlet Hastanesi (Eastern Mediterranean University)
Famagusta, Northern Cyprus, 99680
Doğu Akdeniz Üniveristesi
Famagusta, 05428789621
Eastern Mediterranean University (Gazimağusa Devlet Hastanesi)
Gazimağusa (Famagusta, North Cyprus), Northern Cyprus, 99628
About this study
Official title: The Effect Of Coffee And Tea Drink On Gis Functions Healing Quality After Surgery In Patients Surgery
The positive effects of coffee on general health, central nervous system, cardiovascular system and bowel movements in healthy people are known. In a few studies conducted in recent years, it is stated that coffee consumption is a safe and effective method for accelerating bowel movements after surgical intervention.
It is known that many plants have been used for medicinal purposes since ancient times in the world. Among these plants is fennel (foeniculum vulgare). The fennel plant was used as a spice in Greece and Rome, as well as recognized and used for medicinal purposes. Fennel, dyspeptic ailments; it is effective in spasmodic gastrointestinal complaints, bloating, gas and upper respiratory tract disorders This research; A randomized controlled study was planned to evaluate the effects of Turkish coffee and fennel tea consumption on patients' gastrointestinal functions and healing quality after laparoscopic cholecystectomy surgery.
Read the detailed description
Surgical interventions can be large or small, planned or urgent, but they have physiological and psychological effects on people. The most obvious physiological effects on the patient are: deterioration of organ functions and vascular system, change in body image, activation of stress-alarm reaction. Another of these physiological effects and the most common one is the changes in the gastrointestinal system. Postoperative ileus, which is defined as the temporary deterioration of gastric motility, causes pre- and postoperative diet restrictions, administration of anesthetics/narcotics, delay in gastric emptying as a result of excessive use of isotonic solutions, and slowing down in bowel movements due to excessive touching of the intestines, especially in abdominal and pelvic surgeries. It is known that current approaches and evidence-based practices regarding treatment and care in surgery can accelerate post-surgical recovery and reduce surgery-related deaths. In this direction, one of the evidence-based applications that has emerged to accelerate post-operative recovery is Enhanced Recovery After Surgery - ERAS, also known as Fast Track Surgery (FTS) protocol. With these new approaches, it has been proven that the time between the onset of bowel movements and the first gas formation is shortened, wound healing is accelerated, infection rates are reduced, and hospital stay is reduced. One of these approaches is coffee consumption in the postoperative period. Coffee is a popular beverage and its effects on general health, the central nervous system and the cardiovascular system are well known. Caffeine is a moderate central nervous system stimulant, and these effects are mediated by adenosine receptors. It acts as a potential antagonist of adenosine receptors in the nervous system. Caffeine and adenosine molecules are similar molecules. Caffeine binds to adenosine receptors, thus reducing the effectiveness of adenosine. As a result, we feel the stimulating effect of caffeine at the highest level. It has been observed that consuming more than 7 cups of coffee per day increases gastric secretion. It is also known that coffee increases bowel movements in healthy people. In a study conducted with patients who underwent laparoscopic orectal surgery, it was determined that bowel movements started 3 hours earlier than the patients in the control group and stayed one day less in the hospital. However, in the literature review, it is observed that there are very limited studies on this subject.
In the literature review, early oral feeding, mobilization and gum chewing were found to be effective in preventing paralytic ileus after abdominal and laparoscopic surgery, increasing patient comfort and shortening hospital stay. However, studies examining the effect of coffee consumption on bowel movements and hospital stay in the early postoperative period are very limited.
Based on this information, this study was planned to evaluate the effects of Turkish coffee and fennel tea drinking on GIS functions and healing quality in patients who underwent laparoscopic laparoscopic cholecystectomy surgery.
- Conditions
- Gastrointestinal Functions
- Being tested
- TURKISH COFFEE DRINK, FENNEL TEA DRINK
- Keywords
- TURKİSH COFFE, FENNEL TEA, GIS FUNCTIONS, HEALING QUALITY, APAROSCOPIC CHOLECYSTECTOMY SURGERY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURKISH COFFEE DRINKOther
TURKISH COFFEE DRINK
FENNEL TEA DRINKOther
FENNEL TEA DRINK
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The patients in this group will rest their bowel movements after starting oral intake at the 6th hour postoperatively. The time of first degassing and the time of first discharge will be recorded by asking verbally. Only evaluation will be made at 6. hours after surgery without intervention in the control group. |
| TURKISH COFFEE DRINKING GROUP - TURKISH COFFEE DRINK | Active comparator | Turkish coffee group after the patients in start oral intake at the 6th hour after the surgery, 7 gr of Turkish coffee in 75 ml of water will be boiled with water at 50-60°C, prepared by the researcher and given to the patients to drink. Bowel movements will be rested before and after the intake of Turkish coffee. The time of first degassing and the time of first discharge will be recorded by asking verbally.
Evaluation will be made at the 0th hour after the operation without application. The application will be made at the 6th hour after the surgery and the gıs functıons and healıng qualıty will be evaluated. Receives: Other: TURKISH COFFEE DRINK |
| FENNEL TEA DRINKING GROUP- FENNEL TEA DRINK | Active comparator | fennal tea group after the patients in start oral intake at the 6th hour postoperatively, 150 ml of boiled water at 100˚C will be added to 2 g of fennel seeds, and then infused for 5-10 minutes, they will be given to the patients to drink. Bowel movements will be rested before and after fennel tea intake. The time of first degassing and the time of first discharge will be recorded by asking verbally.
Evaluation will be made at the 0th hour after the operation without application. The application will be made at the 6th hour after the surgery and the gıs functıons and healıng qualıty will be evaluated. Receives: Other: FENNEL TEA DRINK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Form For Evaluation Of The Patient's Gastrointestinal Functions
Marking will be Yes or No. For example, is there gas output? yes/no
Measured: one day first 6 th hour
Quality Of Healing Scale
minıimum=never maximum=always
Measured: one day first 6 th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start5 Aug 2023
- Primary completion30 Dec 2023
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal FunctionsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Therre Groups. Group were comprised of control group, fennel tea drink group, turkısh coffee drink group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Dürüst Sakallı, Eastern Mediterranean University
- Investigators
- GÜLCAN DÜRÜST SAKALLI, lecturer, Principal investigator, Doğu Akdeniz Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180135
- Sponsor's protocol ID
- EasternMU-SBF-HB-GDS-02
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Coffee And Tea Drink On Gis Functions Healing Quality After Surgery In Patients Surgery
- ClinicalTrials.gov ID
- NCT06180135
- Acronym / sponsor ID
- EasternMU-SBF-HB-GDS-02
- Conditions
- Gastrointestinal Functions
- Keywords
- TURKİSH COFFE, FENNEL TEA, GIS FUNCTIONS, HEALING QUALITY, APAROSCOPIC CHOLECYSTECTOMY SURGERY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 22 Dec 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.
The positive effects of coffee on general health, central nervous system, cardiovascular system and bowel movements in healthy people are known. In a few studies conducted in recent years, it is stated that coffee consumption is a safe and effective method for accelerating bowel movements after surgical intervention.
It is known that many plants have been used for medicinal purposes since ancient times in the world. Among these plants is fennel (foeniculum vulgare). The fennel plant was used as a spice in Greece and Rome, as well as recognized and used for medicinal purposes. Fennel, dyspeptic ailments; it is effective in spasmodic gastrointestinal complaints, bloating, gas and upper respiratory tract disorders This research; A randomized controlled study was planned to evaluate the effects of Turkish coffee and fennel tea consumption on patients' gastrointestinal functions and healing quality after laparoscopic cholecystectomy surgery.
Detailed description
Surgical interventions can be large or small, planned or urgent, but they have physiological and psychological effects on people. The most obvious physiological effects on the patient are: deterioration of organ functions and vascular system, change in body image, activation of stress-alarm reaction. Another of these physiological effects and the most common one is the changes in the gastrointestinal system. Postoperative ileus, which is defined as the temporary deterioration of gastric motility, causes pre- and postoperative diet restrictions, administration of anesthetics/narcotics, delay in gastric emptying as a result of excessive use of isotonic solutions, and slowing down in bowel movements due to excessive touching of the intestines, especially in abdominal and pelvic surgeries. It is known that current approaches and evidence-based practices regarding treatment and care in surgery can accelerate post-surgical recovery and reduce surgery-related deaths. In this direction, one of the evidence-based applications that has emerged to accelerate post-operative recovery is Enhanced Recovery After Surgery - ERAS, also known as Fast Track Surgery (FTS) protocol. With these new approaches, it has been proven that the time between the onset of bowel movements and the first gas formation is shortened, wound healing is accelerated, infection rates are reduced, and hospital stay is reduced. One of these approaches is coffee consumption in the postoperative period. Coffee is a popular beverage and its effects on general health, the central nervous system and the cardiovascular system are well known. Caffeine is a moderate central nervous system stimulant, and these effects are mediated by adenosine receptors. It acts as a potential antagonist of adenosine receptors in the nervous system. Caffeine and adenosine molecules are similar molecules. Caffeine binds to adenosine receptors, thus reducing the effectiveness of adenosine. As a result, we feel the stimulating effect of caffeine at the highest level. It has been observed that consuming more than 7 cups of coffee per day increases gastric secretion. It is also known that coffee increases bowel movements in healthy people. In a study conducted with patients who underwent laparoscopic orectal surgery, it was determined that bowel movements started 3 hours earlier than the patients in the control group and stayed one day less in the hospital. However, in the literature review, it is observed that there are very limited studies on this subject.
In the literature review, early oral feeding, mobilization and gum chewing were found to be effective in preventing paralytic ileus after abdominal and laparoscopic surgery, increasing patient comfort and shortening hospital stay. However, studies examining the effect of coffee consumption on bowel movements and hospital stay in the early postoperative period are very limited.
Based on this information, this study was planned to evaluate the effects of Turkish coffee and fennel tea drinking on GIS functions and healing quality in patients who underwent laparoscopic laparoscopic cholecystectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Therre Groups. Group were comprised of control group, fennel tea drink group, turkısh coffee drink group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The patients in this group will rest their bowel movements after starting oral intake at the 6th hour postoperatively. The time of first degassing and the time of first discharge will be recorded by asking verbally. Only evaluation will be made at 6. hours after surgery without intervention in the control group. |
| TURKISH COFFEE DRINKING GROUP - TURKISH COFFEE DRINK | Active comparator | Other: TURKISH COFFEE DRINKTurkish coffee group after the patients in start oral intake at the 6th hour after the surgery, 7 gr of Turkish coffee in 75 ml of water will be boiled with water at 50-60°C, prepared by the researcher and given to the patients to drink. Bowel movements will be rested before and after the intake of Turkish coffee. The time of first degassing and the time of first discharge will be recorded by asking verbally. Evaluation will be made at the 0th hour after the operation without application. The application will be made at the 6th hour after the surgery and the gıs functıons and healıng qualıty will be evaluated. |
| FENNEL TEA DRINKING GROUP- FENNEL TEA DRINK | Active comparator | Other: FENNEL TEA DRINKfennal tea group after the patients in start oral intake at the 6th hour postoperatively, 150 ml of boiled water at 100˚C will be added to 2 g of fennel seeds, and then infused for 5-10 minutes, they will be given to the patients to drink. Bowel movements will be rested before and after fennel tea intake. The time of first degassing and the time of first discharge will be recorded by asking verbally. Evaluation will be made at the 0th hour after the operation without application. The application will be made at the 6th hour after the surgery and the gıs functıons and healıng qualıty will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have undergone laparoscopic cholecystectomy under general anesthesia
- Patients whose bowel functions do not have all chronic or metabolic features,
- Patients without auditory, mental and past diseases
- Patients who volunteered for the study
Key exclusion criteria (8 listed)
- Patients who did not receive general anesthesia and did not have laparoscopic cholecystectomy surgery
- Those who have any chronic or metabolic disease that will affect intestinal functions,
- Those with auditory, mental and neurological diseases,
- Patients using drugs for psychiatric disorders,
- who are not willing to participate in the research,
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 |
|---|---|---|
| TURKISH COFFEE DRINKTURKISH COFFEE DRINK | Other | TURKISH COFFEE DRINKING GROUP - TURKISH COFFEE DRINK |
| FENNEL TEA DRINKFENNEL TEA DRINK | Other | FENNEL TEA DRINKING GROUP- FENNEL TEA DRINK |
Primary outcome
Form For Evaluation Of The Patient's Gastrointestinal Functions
Time frame: one day first 6 th hour
Marking will be Yes or No. For example, is there gas output? yes/no
Quality Of Healing Scale
Time frame: one day first 6 th hour
minıimum=never maximum=always
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 22 Jan 2025.
- The effect of coffee/caffeine on postoperative ileus following elective colorectal surgery: a meta-analysis of randomized controlled trialsLink provided by the sponsor.
- Effect of Coffee on the Length of Postoperative Ileus After Elective Laparoscopic Left-Sided Colectomy: A Randomized, Prospective Single-Center Study.Link provided by the sponsor.
- The Effect of Fennel Tea Drinking on Postoperative Gut Recovery after Gynecological Malignancies OperationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
GÜLCAN DÜRÜST SAKALLI, lecturer principal investigator
Doğu Akdeniz Üniversitesi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TURKISH COFFEE DRINK and FENNEL TEA DRINK in people with Gastrointestinal Functions, run by Eastern Mediterranean University at 3 sites in Cyprus.
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 8 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cyprus. 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?
Form For Evaluation Of The Patient's Gastrointestinal Functions (time frame: one day first 6 th hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.