NCT06669325

Brief 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. 1.Does Apfel's score accurately predict the occurrence of PONV after laparoscopic cholecystectomy?
  2. 2.Which components of Apfel's score are most strongly associated with PONV?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 30, 2024

Last Update Submit

October 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative Nausea and Vomiting (PONV)

    The number of patients who experience nausea and/or vomiting within 24 hours after laparoscopic cholecystectomy.

    Assessed for 24 hours post-surgery.

Secondary Outcomes (1)

  • Relationship Between Apfel's Score and PONV Incidence

    Assessed for 24 hours post-surgery.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical College and Teaching Hospital, Birgunj

Birgunj, Madesh, Nepal, Nepal

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 1, 2024

Study Start

March 12, 2022

Primary Completion

February 6, 2023

Study Completion

October 28, 2023

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations