Effects of Warm Water on GI System in Laparoscopic Cholecystectomy Patients

NCT06154928 | Completed DMC

• 1 other identifier: Kilis7AralikUNİ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Cholecystectomy; Abdominal Distention

Keywords

Laparoscopic Cholecystectomy; Bowel Movements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Measurement and Evaluation Form:

  up to 18 weeks

Study Arms (2)

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.

Other: Drinking Warm Water Intervention

Interventions

Drinking Warm Water Intervention 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.

Wather Groups

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years old
• having surgery

You may not qualify if:

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

Sponsors & Collaborators

• İslam Elagöz: lead
• Hasan Kalyoncu University: collaborator

Study Sites (1)

Necip Fazıl Kısakürek Şehir Hastanesi

Kahramanmaraş, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assıstant

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: December 4, 2023
• Study Start: January 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)