NCT07380776

Preoperative Education Program on Gastrointestinal Quality of Life in Cholecystectomy Patients

Effects of Preoperative Education Program on Quality of Life for Patients Undergoing Cholecystectomy at Erbil Teaching Hospitals

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. Does preoperative patient education improve postoperative quality of life scores more effectively than the routine intervention alone 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. Participants will: Control group patients receive routine preoperative intervention, while the intervention group will participate in educational sessions on comprehensive preoperative education about gallstones and the cholecystectomy operation

Detailed description

This clinical trial aims to explore the effectiveness of a preoperative health education program on knowledge and quality of life for patients undergoing cholecystectomy in surgical wards at public teaching hospitals in Erbil City, Iraq. Gallstone disease (GSD) is one of the most common leading causes of morbidity and biliary tract diseases worldwide. Gallstones constitute a significant health problem in developed societies, affecting 10% to 15% of the adult population, and are associated with a significant health and financial burden. Inadequate health education and the absence of structured preoperative counseling programs have contributed to inconsistent knowledge among patients and variable recovery outcomes following the cholecystectomy procedure. This study will evaluate whether equipping patients who are undergoing cholecystectomy with comprehensive preoperative education enhances the postoperative quality of life and postoperative outcomes. The study will involve two groups of patients with confirmed cholelithiasis who are undergoing cholecystectomy Intervention group: patients receiving a comprehensive preoperative educational program will cover: * General information about the gallbladder included nine questions covered (physiological function of GB, positive indicator signs and symptoms of gallstones, laboratory test indicators for gallstones, which gender and age groups are at higher risk of developing gallstones, common diagnostic tools, and standard methods of treatment for symptomatic patients). * Patient information about cholecystectomy surgery included five questions covered (number of small incisions in the laparoscopic method, advantages of the laparoscopic method, absolute contraindications of cholecystectomy, situation of operation conversion from laparoscopic to open, and contraindications of both types of open and laparoscopic cholecystectomy). * Patient's information about preoperative preparations included nine questions covering essential investigations and diagnostic tests before operation, informed consent concerning the reason for fasting before surgery, skin preparation (operative site), the appropriate type of soap for skin preparation, cosmetic use before operation, the type of medication the patients must stop before surgery, personal item removal, and the type of clothes recommended for surgery. * Postoperative care included eight questions covered (position after surgery, postoperative complications avoided by early ambulation, gastrointestinal symptoms after surgery, normal period, can the patients return to work and daily activities, postoperative exercises such as deep breathing and coughing, leg and ankle pump exercises, ankle circle exercises, and changing position). * Patients' information about discharge guidelines included six questions covering steps of keeping the wound area clean after surgery, the importance of avoiding soaking in pools or showers for a long time after surgery, eating times per day after surgery, nutrients recommended after surgery, signs and symptoms of wound infection, and situations that need immediate calling or visiting the physician. The primary outcome will be the change and improvement in postoperative quality of life score and patients' outcomes over a specific period. Secondary outcomes will include patient knowledge and practice measured through a pre- and post-intervention structured questionnaire. The participants, after one month, will attend follow-up visits where the quality of life will be assessed, and patients will be assessed for their knowledge and understanding of the preoperative educational guidance provided. Data on patients will also be collected and analyzed.

Conditions

• Preoperative Patient Education , Quality of Life , Cholecystectomy

Interventions

Type	Name	Description
OTHER	preoperative educatinal program	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

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2026-02-02
• Last updated: 2026-02-06

Locations

1 site across 1 country: Iraq