Laparoscopic CholecystectomyLCSSNCT06154928
Effects of Warm Water on GI System in Laparoscopic Cholecystectomy Patients
A study testing Drinking Warm Water Intervention in people with Laparoscopic Cholecystectomy and Abdominal Distention, run by İslam Elagöz at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study was carried out to determine the effect of drinking warm water on GIS functions in patients who underwent laparoscopic cholecystectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy, Abdominal Distention
- What is being tested?
- Drinking Warm Water Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Aug 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
- over 18 years old
- having surgery
Who cannot join
- not meeting the sampling criteria
- Refused to participate Canceled surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necip Fazıl Kısakürek Şehir Hastanesi
Kahramanmaraş
About this study
Official title: Investigation of the Effect of Drinking Warm Water on the Gastrointestinal System Functions of Patients Undergoing Laparoscopic Cholecystectomy
Objective: The study was carried out to determine the effect of drinking warm water on GIS functions in patients who underwent laparoscopic cholecystectomy surgery.
Read the detailed description
Method: The research was completed in Kahramanmaraş Necip Fazıl City Hospital with 100 patients, 50 of whom were in the Study Group (WG) and 50 were in the Control Group (KG). The patients in CG were given warm water to drink at the 2nd hour after surgery. On the other hand, patients in KG were allowed to drink warm water after bowel sounds started and gas was produced. Patients in both groups were 2,4,8,12 after surgery. hours were evaluated in terms of GIS functions. Statistical analysis was done in SPSS 22.0 for Windows package program. A p<0.05 value was accepted for statistical significance.
- Conditions
- Laparoscopic Cholecystectomy, Abdominal Distention
- Being tested
- Drinking Warm Water Intervention
- Keywords
- Laparoscopic Cholecystectomy, Bowel Movements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinking Warm Water InterventionOther
Patients in the Warm Water Group (WG) received a warm water drinking intervention post-laparoscopic cholecystectomy. Before intake, the bed head was elevated to 45°C, and gagging and swallowing reflexes were assessed using an Abeslang to touch the oropharynx. Nausea indicated a positive reflex. Two patients with negative reflexes were excluded from WG. To maintain water temperature, individual insulated cups with thermal features were used, preventing infection transmission. Water was boiled in a clinic kettle, cooled to 37-38°C, and given to patients to drink within 15 minutes. Swallowing ability was monitored after the first sip; successful swallowing allowed the patient to continue. Patients were observed for 15 minutes with an aspirator on standby for aspiration risks. No complications occurred during the water drinking process in WG.
| Study group | Role | What they receive |
|---|---|---|
| Control Groups | No intervention | Routine treatment and care of patients in the CG was continued. The onset of bowel sounds and flatus requires the initiation of oral fluid and nutrient intake. Patients in the CG were evaluated at T0, T1, T2, and T3, and data were recorded on a data collection form. |
| Wather Groups | Experimental | Patients in the WG were provided warm water at the 2nd postoperative hour on the day of surgery. Patients in the WG were evaluated at T0, T1, T2, and T3 and data were recorded on a data collection form. The onset of bowel sounds and flatus requires the initiation of oral fluid and nutrient intake. No other water or food was provided to patients who had no bowel sounds or flatus other than warm water. Receives: Other: Drinking Warm Water Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Information Form:
The descriptive information form consisted of two parts. The first part comprised seven open-ended and five multiple-choice questions to determine the patients' descriptive characteristics. This part of the form was completed by the patients 1 day before surgery. The second part comprised nine multiple-choice questions aimed at determining the patients' surgical characteristics. This diagnostic information was provided by the researcher.
Measured: up to 18 weeks
Secondary outcomes (1)
Postoperative Measurement and Evaluation Form:
The postoperative measurement and evaluation form included nine open-ended and seven multiple-choice questions designed to determine the vital signs and GI functions of the patients. Patients were evaluated during the postoperative period and the findings are presented in the relevant sections.
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Jan 2021
- Primary completion1 Apr 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This single-center randomized controlled study, conducted between January 15 and May 15, 2022, comprised 100 patients equally divided into the Water Group (WG) and Control Group (CG). Patients in the WG were allowed to take warm water orally during the 2nd postoperative hour without waiting for the onset of bowel sounds or flatus while those in the CG were not. GI functions were evaluated at 2, 4, 8, and 12 postoperative hours and the findings were recorded.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- İslam Elagöz
- Sponsor type
- University, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Responsible party
- Sponsor-investigator, İslam Elagöz, Kilis 7 Aralik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154928
- Sponsor's protocol ID
- Kilis7AralikUNİ
- Acronym
- LCSS
- Status last verified
- Nov 2023
- First submitted
- 22 Mar 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Drinking Warm Water on the Gastrointestinal System Functions of Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06154928
- Acronym / sponsor ID
- LCSS / Kilis7AralikUNİ
- Conditions
- Laparoscopic Cholecystectomy, Abdominal Distention
- Keywords
- Laparoscopic Cholecystectomy, Bowel Movements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- İslam ElagözUniversity, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 4 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.
Objective: The study was carried out to determine the effect of drinking warm water on GIS functions in patients who underwent laparoscopic cholecystectomy surgery.
Detailed description
Method: The research was completed in Kahramanmaraş Necip Fazıl City Hospital with 100 patients, 50 of whom were in the Study Group (WG) and 50 were in the Control Group (KG). The patients in CG were given warm water to drink at the 2nd hour after surgery. On the other hand, patients in KG were allowed to drink warm water after bowel sounds started and gas was produced. Patients in both groups were 2,4,8,12 after surgery. hours were evaluated in terms of GIS functions. Statistical analysis was done in SPSS 22.0 for Windows package program. A p<0.05 value was accepted for statistical significance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This single-center randomized controlled study, conducted between January 15 and May 15, 2022, comprised 100 patients equally divided into the Water Group (WG) and Control Group (CG). Patients in the WG were allowed to take warm water orally during the 2nd postoperative hour without waiting for the onset of bowel sounds or flatus while those in the CG were not. GI functions were evaluated at 2, 4, 8, and 12 postoperative hours and the findings were recorded.
| Arm | Type | Receives |
|---|---|---|
| Control Groups | No intervention | –Routine treatment and care of patients in the CG was continued. The onset of bowel sounds and flatus requires the initiation of oral fluid and nutrient intake. Patients in the CG were evaluated at T0, T1, T2, and T3, and data were recorded on a data collection form. |
| Wather Groups | Experimental | Other: Drinking Warm Water InterventionPatients in the WG were provided warm water at the 2nd postoperative hour on the day of surgery. Patients in the WG were evaluated at T0, T1, T2, and T3 and data were recorded on a data collection form. The onset of bowel sounds and flatus requires the initiation of oral fluid and nutrient intake. No other water or food was provided to patients who had no bowel sounds or flatus other than warm water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years old
- having surgery
Key exclusion criteria (2 listed)
- not meeting the sampling criteria
- Refused to participate Canceled surgery
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 |
|---|---|---|
| Drinking Warm Water InterventionPatients in the Warm Water Group (WG) received a warm water drinking intervention post-laparoscopic cholecystectomy. Before intake, the bed head was elevated to 45°C, and gagging and swallowing reflexes were assessed using an Abeslang to touch the oropharynx. Nausea indicated a positive reflex. Two patients with negative reflexes were excluded from WG. To maintain water temperature, individual insulated cups with thermal features were used, preventing infection transmission. Water was boiled in a clinic kettle, cooled to 37-38°C, and given to patients to drink within 15 minutes. Swallowing ability was monitored after the first sip; successful swallowing allowed the patient to continue. Patients were observed for 15 minutes with an aspirator on standby for aspiration risks. No complications occurred during the water drinking process in WG. | Other | Wather Groups |
Primary outcome
Descriptive Information Form:
Time frame: up to 18 weeks
The descriptive information form consisted of two parts. The first part comprised seven open-ended and five multiple-choice questions to determine the patients' descriptive characteristics. This part of the form was completed by the patients 1 day before surgery. The second part comprised nine multiple-choice questions aimed at determining the patients' surgical characteristics. This diagnostic information was provided by the researcher.
1 secondary outcome
Postoperative Measurement and Evaluation Form:
Time frame: up to 18 weeks
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 4 Dec 2023.
- 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.
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?
A study testing Drinking Warm Water Intervention in people with Laparoscopic Cholecystectomy and Abdominal Distention, run by İslam Elagöz at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 4 Dec 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?
Descriptive Information Form: (time frame: up to 18 weeks). 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 4 Dec 2023.