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
Sponsored by Danderyd Hospital
About this trial
Last updated 3 years ago
Study ID
DanderydH
Status
Enrolling by invitation
Type
Observational [Patient Registry]
Placebo
No
Accepting
18 to 75 Years
Female
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- ASA class 1-2
Exclusion Criteria
- ASA 4, obese