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

Study Overview
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Brief Summary
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SYNOPSIS Title: An observational study to investigate Quality of Recovery and the incidence and impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) and up to 7 days in females undergoing laparoscopic abdominal surgery provided Apfel-score based PONV care and prophylaxis. 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.

Official Title
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An Observational Study to Investigate Quality of Recovery, the Incidence and Impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis

Conditions
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Quality of Recovery

Intervention / Treatment
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* Other: Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class 1-2 Exclusion Criteria: ASA 4, obese

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apfel score 1<br>Female | Other: Protocol<br>* Best practice of protocol<br>|
| Apfel score 2<br>Female, non smoker | Other: Protocol<br>* Best practice of protocol<br>|
| Apfel score 3<br>Female, non smoker, under 40 years old | Other: Protocol<br>* Best practice of protocol<br>|
| Apfel score 4<br>Female, non smoker, under 40 years old, previous history of PONV | Other: Protocol<br>* Best practice of protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery, QoR15 (Quality of Recovery 15) | Score, a valid questionnaire to measure quality of recovery, 15 questions, maximum score 150p. VAS scales for each items; 0 bad score, 10 optimal score. Mean values for group, sum score will be compared with parametric tests. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of recovery, PONV, PDNV