Preoperative Education Program on Gastrointestinal Quality of Life in Cholecystectomy Patients

NCT07380776 | Active Not Recruiting DMC

• 1 other identifier: GIQLI Index of cholecystectomy
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether the comprehensive preoperative educational program for patients undergoing cholecystectomy can improve their knowledge and enhance postoperative quality of life compared to patients who receive routine preoperative intervention. The study focuses on patients who underwent cholecystectomy, particularly in the age range from 18 to 75 years, and aim to determine if comprehensive preoperative education has a greater impact on improving the quality of life level then routine intervention alone The main questions it aims to answer are

1. 1.Does preoperative patient education improve postoperative quality of life scores more effectively than the routine intervention alone
2. 2.Does the preoperative education improve the patient's knowledge and practices regarding the cholecystectomy operation? Researchers will compare patients who receive preoperative education to those receiving routine hospital intervention to assess the differences in postoperative quality of life score and patient outcomes.

Conditions

Preoperative Patient Education , Quality of Life , Cholecystectomy

Keywords

preoperative eduaction; gallstone disease; quality of life (GIQLI)

Outcome Measures

Primary Outcomes (1)

• Improvement of the quality of life

  His outcome aims to assess the differences in the level of improvement of their quality of life at the end of the intervention. The study will compare the effectiveness of a comprehensive preoperative educational program versus the routine intervention provided to patients undergoing cholecystectomy. The quality of life will be assessed by using the gastrointestinal Quality of Life Index, providing a quantitative assessment of intervention impact on postoperative quality of life

  one month (measured at baseline and at one month postoperative)

Secondary Outcomes (1)

• improvement in the patients' knowledge about gallstone and cholecystectomy

  (Before the educational intervention, and one month after the operation and education program )

Study Arms (1)

control group (routin hospital pre operative education

ACTIVE COMPARATOR

The routine hospital intervention provided to patients undergoing cholecystectomy is delivered by nursing staff as part of standard care. This education included a clear explanation of the indication for cholecystectomy, as well as information about the surgical procedure and type of anesthesia. Patients were instructed on pre-operative preparation, such as fasting requirements and medication management. Post-operatively, education focused on early ambulation, breathing and coughing exercises to prevent respiratory complications, and gradual resumption of physical activity. In addition, patients received dietary guidance emphasizing a gradual return to oral intake and the avoidance of fatty or fried foods during the recovery period. Discharge education covered medication adherence, follow-up appointments, and the importance of seeking medical attention when necessary. This routine educational intervention aimed to enhance patients' knowledge, promote recovery, and reduce postoperati

Other: preoperative educatinal program

Interventions

preoperative educatinal program OTHER

The Comprehensive Pre-Operative Education program is a structured intervention designed to enhance patients' understanding of gallbladder problems and improve the quality of life of patients suffering from gallstone disease who are undergoing cholecystectomy. The program comprises two individualized education sessions lasting 45 minutes each, focusing on essential topics such as Definition of gallbladder, Main functions of the gallbladder, the common health issues that can affect the gallbladder, the types of gallstones, diagnosis of gallstones, how they are treated, and nonsurgical treatments for gallstones. Complications could potentially occur from gallbladder removal. General pre-operation patient preparation for gallbladder removal surgery, Postoperative Care After Gallbladder Removal Surgery (Cholecystectomy), Dietary Modifications After Surgery, recommendations about how to be away from aggravating factors that affect health status after surgery, discharge instructions, and ins

control group (routin hospital pre operative education

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An adult patient.
• Both genders
• Individuals' interest in participating in the study.
• Patients who were diagnosed with cholelithiasis requiring a cholecystectomy operation confirmed by ultrasound and physical examination
• Ability to attend the educational program
• Conscious patient able to communicate
• Being elective candidates for cholecystectomy

You may not qualify if:

• Who had participated in a previous education program regarding open and laparoscopic cholecystectomy
• Patients who refuse to complete the post-test.
• Those with professional health qualifications
• Patients with mental disabilities and mental illnesses.
• People who changed their opinion about participating in the study or missed consecutive educational intervention sessions for any reason.
• The procedure is done other than standard laparoscopic and open cholecystectomy.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Medical University/College of nursing

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc in adult Nursing (Lecturer at college of nursing / Hawler Medical University

Model Details: interventional parallel-group study

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)