APFEL RİSK SCORENCT06669325
Role of Apfel's Score in Predicting Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
An observational study of APFEL RİSK SCORE and Post Operative Nausea and Vomiting (PONV), run by National Medical College Birgunj at 1 site in Nepal.
Trial summary
The goal of this observational study is to assess the role of Apfel's score in predicting postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy in patients with symptomatic cholelithiasis. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- APFEL RİSK SCORE, Post Operative Nausea and Vomiting (PONV)
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 12 Mar 2022to 28 Oct 2023
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients who are undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. These patients are treated at the Department of General Surgery at National Medical College Teaching Hospital, Birgunj, Nepal.
Who may be able to join
- Patients aged 18 to 90 years.
- Patient scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis.
- Patients who provided written informed consent to participate in the study.
Who cannot join
- Patients receiving prophylactic antiemetic medications prior to surgery.
- Patients on opioid analgesics for reasons other than the surgical procedure.
- Pregnant women.
- Patients whose laparoscopic cholecystectomy was converted to open cholecystectomy during the operation.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
National Medical College and Teaching Hospital, Birgunj
Birgunj, Madesh, Nepal
About this study
The goal of this observational study is to assess the role of Apfel's score in predicting postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy in patients with symptomatic cholelithiasis. The main questions it aims to answer are:
- Does Apfel's score accurately predict the occurrence of PONV after laparoscopic cholecystectomy?
- Which components of Apfel's score are most strongly associated with PONV?
Participants will undergo laparoscopic cholecystectomy under general anesthesia. Researchers will calculate each participant's Apfel score preoperatively, and postoperative outcomes, such as nausea and vomiting, will be monitored for 24 to 48 hours. Researchers will compare PONV incidence among patients with varying Apfel scores to determine if higher scores correlate with a higher risk of PONV.
- Medical subject headings
- Vomiting
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Nausea and Vomiting (PONV)
The number of patients who experience nausea and/or vomiting within 24 hours after laparoscopic cholecystectomy.
Measured: Assessed for 24 hours post-surgery.
Secondary outcomes (1)
Relationship Between Apfel's Score and PONV Incidence
Evaluating the correlation between the Apfel's score (0-4) and the likelihood of PONV in patients after surgery.
Measured: Assessed for 24 hours post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 Mar 2022
- Primary completion6 Feb 2023
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for APFEL RİSK SCOREStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical College Birgunj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajendra Dhakal, National Medical College Birgunj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669325
- Sponsor's protocol ID
- PG-NMC/541/078-079
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators may share de-identified Individual Participant Data (IPD) with other researchers upon reasonable request. Access to the data will be granted after approval by the Institutional Review Committee, and a data-sharing agreement will be required to ensure participant confidentiality and compliance with ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Apfel's Score in Predicting Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06669325
- Acronym / sponsor ID
- PG-NMC/541/078-079
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Medical College BirgunjUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 1 Nov 2024 (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 observational study is to assess the role of Apfel's score in predicting postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy in patients with symptomatic cholelithiasis. The main questions it aims to answer are:
- Does Apfel's score accurately predict the occurrence of PONV after laparoscopic cholecystectomy?
- Which components of Apfel's score are most strongly associated with PONV?
Participants will undergo laparoscopic cholecystectomy under general anesthesia. Researchers will calculate each participant's Apfel score preoperatively, and postoperative outcomes, such as nausea and vomiting, will be monitored for 24 to 48 hours. Researchers will compare PONV incidence among patients with varying Apfel scores to determine if higher scores correlate with a higher risk of PONV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients who are undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. These patients are treated at the Department of General Surgery at National Medical College Teaching Hospital, Birgunj, Nepal.
Key inclusion criteria (3 listed)
- Patients aged 18 to 90 years.
- Patient scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis.
- Patients who provided written informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Patients receiving prophylactic antiemetic medications prior to surgery.
- Patients on opioid analgesics for reasons other than the surgical procedure.
- Pregnant women.
- Patients whose laparoscopic cholecystectomy was converted to open cholecystectomy during the operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Assessed for 24 hours post-surgery.
The number of patients who experience nausea and/or vomiting within 24 hours after laparoscopic cholecystectomy.
1 secondary outcome
Relationship Between Apfel's Score and PONV Incidence
Time frame: Assessed for 24 hours post-surgery.
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 4 Nov 2024.
- Individual participant dataSharing planned: Undecided. The investigators may share de-identified Individual Participant Data (IPD) with other researchers upon reasonable request. Access to the data will be granted after approval by the Institutional Review Committee, and a data-sharing agreement will be required to ensure participant confidentiality and compliance with ethical standards.
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?
An observational study of APFEL RİSK SCORE and Post Operative Nausea and Vomiting (PONV), run by National Medical College Birgunj at 1 site in Nepal.
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 4 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 4 Nov 2024. 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 Nepal. 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?
Incidence of Postoperative Nausea and Vomiting (PONV) (time frame: Assessed for 24 hours post-surgery.). 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 4 Nov 2024.