Preoperative Patient Education , Quality of Life , CholecystectomyPEP-GIQLINCT07380776
Preoperative Education Program on Gastrointestinal Quality of Life in Cholecystectomy Patients
A study testing preoperative educatinal program in people with Preoperative Patient Education , Quality of Life , Cholecystectomy, run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Preoperative Patient Education , Quality of Life , Cholecystectomy
- What is being tested?
- preoperative educatinal program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Hawler Medical University/College of nursing
Erbil, Kurdistan Region, 44001
About this study
Official title: Effects of Preoperative Education Program on Quality of Life for Patients Undergoing Cholecystectomy at Erbil Teaching Hospitals
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
- Does preoperative patient education improve postoperative quality of life scores more effectively than the routine intervention alone
- 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.
Read more
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
Read the 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.
- Being tested
- preoperative educatinal program
- Keywords
- preoperative eduaction, gallstone disease, quality of life (GIQLI)
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative educatinal programOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: preoperative educatinal program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month (measured at baseline and at one month postoperative)
Secondary outcomes (1)
improvement in the patients' knowledge about gallstone and cholecystectomy
His measure will assess the change in the patient's knowledge regarding the gallstone and cholecystectomy operation before and after the education program. The assessment will be conducted using a validated structured questionnaire that gauges understanding of general information about gallbladder anatomy, cholecystectomy operation, preoperative preparation, postoperative care, and discharge guidelines after the operation.
Measured: (Before the educational intervention, and one month after the operation and education program )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative Patient Education , Quality of Life , CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional parallel-group study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURHAN IZZADDIN SABIR SALIH, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380776
- Sponsor's protocol ID
- GIQLI Index of cholecystectomy
- Acronym
- PEP-GIQLI
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Izzadin Sabir B, Mohammed Younis Y. Impact of a health education program on knowledge and quality of life among patients undergoing cholecystectomy in public teaching hospitals in Erbil. Front Surg. 2026 May 12;13:1825682. doi: 10.3389/fsurg.2026.1825682. eCollection 2026.
PubMed 42205189
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Education Program on Quality of Life for Patients Undergoing Cholecystectomy at Erbil Teaching Hospitals
- ClinicalTrials.gov ID
- NCT07380776
- Acronym / sponsor ID
- PEP-GIQLI / GIQLI Index of cholecystectomy
- Keywords
- preoperative eduaction, gallstone disease, quality of life (GIQLI)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Does preoperative patient education improve postoperative quality of life scores more effectively than the routine intervention alone
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional parallel-group study
| Arm | Type | Receives |
|---|---|---|
| control group (routin hospital pre operative education | Active comparator | Other: preoperative educatinal programThe 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative educatinal programThe 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 | Other | control group (routin hospital pre operative education |
Primary outcome
Improvement of the quality of life
Time frame: one month (measured at baseline and at one month postoperative)
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
1 secondary outcome
improvement in the patients' knowledge about gallstone and cholecystectomy
Time frame: (Before the educational intervention, and one month after the operation and education program )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 42205189Izzadin Sabir B, Mohammed Younis Y. Impact of a health education program on knowledge and quality of life among patients undergoing cholecystectomy in public teaching hospitals in Erbil. Front Surg. 2026 May 12;13:1825682. doi: 10.3389/fsurg.2026.1825682. eCollection 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative educatinal program in people with Preoperative Patient Education , Quality of Life , Cholecystectomy, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the quality of life (time frame: one month (measured at baseline and at one month postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07380776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.