A Study to Investigate Quality of Recovery up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis
NCT ID: NCT03820479
Last Updated: 2025-07-10
Study Results
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Basic Information
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COMPLETED
98 participants
OBSERVATIONAL
2019-02-11
2024-05-15
Brief Summary
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Study period: September 2018- September 2019
Hypothesis: When a high risk patient, Apfel-score 3 or 4, is given Apfel-score based PONV care with strict adherence to PONV guidelines there should be no difference in Quality of Recovery between a high-risk patient and a low-risk patient.
Aim: The aim of the study is to investigate if it is possible to reach no difference in Quality of Recovery (QoR) between a high-risk patient and a low risk patient using Apfel-score based PONV care.
Primary objective: Assessing Quality of Recovery, using QoR15 at 24h, 48h, 72h and after 7 days.
Secondary objectives: Assessing the incidence and severity of PONV and PDNV in females undergoing laparoscopic surgery up to 72h. Assessing PONV and PDNV severity and duration. Nicotine habits and impact on PONV.
Study outline: Females scheduled for elective abdominal laparoscopic surgery will be provided PONV care based on Apfel risk-score. All patients will fill in the QoR15 form before surgery (base line). PONV and PDNV will be assessed in the PACU postoperatively, after 24h, 48h and 72h. Quality of Recovery will be assessed up to 7 days after surgery.
Treatment: The females will be given ordinary care after local routines, with strict adherence to PONV guidelines.
Study population: 100 females aged 18-65, ASA 1-2, undergoing laparoscopic abdominal surgery in Danderyds Hospital.
Primary outcome variables and examinations: When the QoR 15 reaches base line or better after surgery. Number of times the females experience nausea, retching or vomiting and the impact of emetic symptoms on the QoR.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Apfel score 1
Female
Protocol
Best practice of protocol
Apfel score 2
Female, non smoker
Protocol
Best practice of protocol
Apfel score 3
Female, non smoker, under 40 years old
Protocol
Best practice of protocol
Apfel score 4
Female, non smoker, under 40 years old, previous history of PONV
Protocol
Best practice of protocol
Interventions
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Protocol
Best practice of protocol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
FEMALE
No
Sponsors
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Danderyd Hospital
OTHER
Responsible Party
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EmmaObrink
Principal Investigator
Locations
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Danderyds Sjukhus
Stockholm, , Sweden
Countries
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Other Identifiers
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DanderydH
Identifier Type: -
Identifier Source: org_study_id
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