Effects of Warm Water on GI System in Laparoscopic Cholecystectomy Patients (LCSS)

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy; Abdominal Distention
• Intervention / Treatment: Other: Drinking Warm Water Intervention

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaraş, Turkey
    • Necip Fazıl Kısakürek Şehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• over 18 years old
• having surgery

Exclusion Criteria:

• not meeting the sampling criteria
• Refused to participate Canceled surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 18 weeks

Collaborators and Investigators

• Sponsor: İslam Elagöz
• Collaborators: Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic Cholecystectomy; Bowel Movements
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: Kilis7AralikUNİ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No