Effects of Warm Water on GI System in Laparoscopic Cholecystectomy Patients

NCT ID: NCT06154928

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic Cholecystectomy Abdominal Distention

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Laparoscopic Cholecystectomy Bowel Movements

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Groups

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Wather Groups

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.

Group Type EXPERIMENTAL

Drinking Warm Water Intervention

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drinking Warm Water Intervention

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* over 18 years old
* having surgery

Exclusion Criteria

* not meeting the sampling criteria
* Refused to participate Canceled surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hasan Kalyoncu University

OTHER

Sponsor Role collaborator

İslam Elagöz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

İslam Elagöz

Research Assıstant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Necip Fazıl Kısakürek Şehir Hastanesi

Kahramanmaraş, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Kilis7AralikUNİ

Identifier Type: -

Identifier Source: org_study_id