Laparoscopic CholecystectomyVAE-LCNCT07277036
Video-Assisted Education After Laparoscopic Cholecystectomy
A study testing Video-Assisted Patient Education in people with Laparoscopic Cholecystectomy and Patient Education, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary: This randomized controlled trial aims to evaluate the effects of video-assisted preoperative education on postoperative physiological parameters and recovery outcomes in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy, Patient Education
- What is being tested?
- Video-Assisted Patient Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 17 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) undergoing elective laparoscopic cholecystectomy at the study hospital.
- Able to provide written informed consent and to receive/understand the education materials.
- Willing to complete postoperative assessments at discharge and on postoperative day 5-7
Who cannot join
- Impaired consciousness, speech difficulties, hearing impairment, or diagnosed psychiatric conditions that would preclude receiving the educational intervention or valid assessment.
- (Operational exclusions after enrollment): cancellation of surgery, refusal to continue participation, or incomplete data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Video-Assisted Education on Postoperative Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Brief Summary:
This randomized controlled trial aims to evaluate the effects of video-assisted preoperative education on postoperative physiological parameters and recovery outcomes in patients undergoing laparoscopic cholecystectomy. The study compares a video-based education program with brochure-based education covering pain and nausea-vomiting management, nutrition, early mobilization, fluid intake, wound care, bathing, and follow-up instructions in adults scheduled for elective laparoscopic cholecystectomy in a public state hospital in Türkiye.
Read the detailed description
Laparoscopic cholecystectomy is a widely used minimally invasive surgical method to treat gallstones. Effective preoperative education is critical to enhance postoperative recovery and reduce complications. This randomized controlled trial was conducted between October 1, 2023, and January 17, 2024, in the General Surgery Department of a public state hospital in Türkiye. The primary aim of the study is to determine the effects of video-assisted education on postoperative physiological parameters and recovery outcomes of patients undergoing laparoscopic cholecystectomy. A total of 92 adult patients scheduled for elective laparoscopic cholecystectomy are randomly assigned to an intervention group (n = 46) and a control group (n = 46) using a randomized allocation procedure. The intervention group receives structured video-assisted education, whereas the control group receives the same educational content through a printed brochure. The educational content includes information on postoperative pain and nausea-vomiting management, nutrition, early mobilization, adequate fluid intake, wound care, bathing, and follow-up instructions. Education is delivered preoperatively by a trained nurse.
Data are collected using a sociodemographic data form, the Visual Analog Scale (VAS) for pain, a pre-/postoperative patient assessment form, and a dietary habits questionnaire. Physiological parameters (vital signs, SpO₂, blood glucose), functional recovery indicators (defecation, mobilization, bathing), and selected self-care behaviors are assessed at predefined time points (preoperative baseline, discharge day, and postoperative follow-up day).
The primary outcomes are postoperative bowel recovery (e.g., presence and timing of defecation) and selected self-care-related recovery indicators (e.g., bathing status, need for family assistance). Secondary outcomes include postoperative nausea-vomiting, pain intensity, vital signs, and dietary habits. The study is designed to inform nursing practice regarding the use of video-assisted education compared with brochure-based education in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Laparoscopic Cholecystectomy, Patient Education
- Being tested
- Video-Assisted Patient Education
- Keywords
- Video-assisted education, patient education, defecation, self-care, postoperative recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Assisted Patient EducationBehavioural
Single-session video-assisted patient education delivered before hospital discharge after laparoscopic cholecystectomy. A standardized 10-15-minute video (shown on a tablet/TV by a nurse) covers postoperative care: pain control/analgesic use, early mobilization, wound care, diet/fluids, warning signs, and follow-up. Participants also receive routine discharge instructions; the video is an adjunct unique to this arm and is not provided to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Video-Assisted Education | Experimental | Single-session video-assisted patient education in addition to routine postoperative instructions Receives: Behavioral: Video-Assisted Patient Education |
| Usual Care | No intervention | Routine postoperative discharge education without the video component. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defecation Occurrence
Proportion of participants who report at least one bowel movement by the follow-up day, recorded via the standardized patient assessment form. Higher proportions indicate faster gastrointestinal recovery. Groups compared: Video-Assisted Education vs. Usual Care
Measured: Postoperative day 5-7 (follow-up)
Secondary outcomes (1)
Postoperative Nausea and Vomiting (Yes/No)
Any nausea or ≥1 vomiting episode on the day of discharge; proportions compared between groups.
Measured: At hospital discharge (postoperative day 0-1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Oct 2023
- Primary completion10 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Tinaztepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dizer, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277036
- Sponsor's protocol ID
- İzmirTınaztepeÜ-B.Dizer-002
- Acronym
- VAE-LC
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent/IRB approval did not include permission for public deposition of individual participant-level data. In accordance with local privacy regulations (e.g., Türkiye's KVKK), IPD will not be shared. A de-identified minimal dataset supporting the main findings is available as Supplementary File S1; additional de-identified/aggregated data may be provided by the corresponding author upon reasonable request under a data-use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-Assisted Education on Postoperative Outcomes After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07277036
- Acronym / sponsor ID
- VAE-LC / İzmirTınaztepeÜ-B.Dizer-002
- Conditions
- Laparoscopic Cholecystectomy, Patient Education
- Keywords
- Video-assisted education, patient education, defecation, self-care, postoperative recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Izmir Tinaztepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 11 Dec 2025 (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.
Brief Summary:
This randomized controlled trial aims to evaluate the effects of video-assisted preoperative education on postoperative physiological parameters and recovery outcomes in patients undergoing laparoscopic cholecystectomy. The study compares a video-based education program with brochure-based education covering pain and nausea-vomiting management, nutrition, early mobilization, fluid intake, wound care, bathing, and follow-up instructions in adults scheduled for elective laparoscopic cholecystectomy in a public state hospital in Türkiye.
Detailed description
Laparoscopic cholecystectomy is a widely used minimally invasive surgical method to treat gallstones. Effective preoperative education is critical to enhance postoperative recovery and reduce complications. This randomized controlled trial was conducted between October 1, 2023, and January 17, 2024, in the General Surgery Department of a public state hospital in Türkiye. The primary aim of the study is to determine the effects of video-assisted education on postoperative physiological parameters and recovery outcomes of patients undergoing laparoscopic cholecystectomy. A total of 92 adult patients scheduled for elective laparoscopic cholecystectomy are randomly assigned to an intervention group (n = 46) and a control group (n = 46) using a randomized allocation procedure. The intervention group receives structured video-assisted education, whereas the control group receives the same educational content through a printed brochure. The educational content includes information on postoperative pain and nausea-vomiting management, nutrition, early mobilization, adequate fluid intake, wound care, bathing, and follow-up instructions. Education is delivered preoperatively by a trained nurse.
Data are collected using a sociodemographic data form, the Visual Analog Scale (VAS) for pain, a pre-/postoperative patient assessment form, and a dietary habits questionnaire. Physiological parameters (vital signs, SpO₂, blood glucose), functional recovery indicators (defecation, mobilization, bathing), and selected self-care behaviors are assessed at predefined time points (preoperative baseline, discharge day, and postoperative follow-up day).
The primary outcomes are postoperative bowel recovery (e.g., presence and timing of defecation) and selected self-care-related recovery indicators (e.g., bathing status, need for family assistance). Secondary outcomes include postoperative nausea-vomiting, pain intensity, vital signs, and dietary habits. The study is designed to inform nursing practice regarding the use of video-assisted education compared with brochure-based education in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-Assisted Education | Experimental | Behavioral: Video-Assisted Patient EducationSingle-session video-assisted patient education in addition to routine postoperative instructions |
| Usual Care | No intervention | –Routine postoperative discharge education without the video component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) undergoing elective laparoscopic cholecystectomy at the study hospital.
- Able to provide written informed consent and to receive/understand the education materials.
- Willing to complete postoperative assessments at discharge and on postoperative day 5-7
Key exclusion criteria (2 listed)
- Impaired consciousness, speech difficulties, hearing impairment, or diagnosed psychiatric conditions that would preclude receiving the educational intervention or valid assessment.
- (Operational exclusions after enrollment): cancellation of surgery, refusal to continue participation, or incomplete data collection
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 |
|---|---|---|
| Video-Assisted Patient EducationSingle-session video-assisted patient education delivered before hospital discharge after laparoscopic cholecystectomy. A standardized 10-15-minute video (shown on a tablet/TV by a nurse) covers postoperative care: pain control/analgesic use, early mobilization, wound care, diet/fluids, warning signs, and follow-up. Participants also receive routine discharge instructions; the video is an adjunct unique to this arm and is not provided to the control group. | Behavioural | Video-Assisted Education |
Primary outcome
Defecation Occurrence
Time frame: Postoperative day 5-7 (follow-up)
Proportion of participants who report at least one bowel movement by the follow-up day, recorded via the standardized patient assessment form. Higher proportions indicate faster gastrointestinal recovery. Groups compared: Video-Assisted Education vs. Usual Care
1 secondary outcome
Postoperative Nausea and Vomiting (Yes/No)
Time frame: At hospital discharge (postoperative day 0-1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No. The informed consent/IRB approval did not include permission for public deposition of individual participant-level data. In accordance with local privacy regulations (e.g., Türkiye's KVKK), IPD will not be shared. A de-identified minimal dataset supporting the main findings is available as Supplementary File S1; additional de-identified/aggregated data may be provided by the corresponding author upon reasonable request under a data-use agreement.
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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 Video-Assisted Patient Education in people with Laparoscopic Cholecystectomy and Patient Education, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Defecation Occurrence (time frame: Postoperative day 5-7 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.