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

• Conditions: Quality of Recovery
• Interventions: Other: Protocol

• Registration Number: NCT03820479
• Lead Sponsor: Danderyd Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Study Start: 2019-02-11
• Primary Completion: 2024-02-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• ASA class 1-2

Exclusion Criteria

• ASA 4, obese

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Apfel score 4	Protocol	Female, non smoker, under 40 years old, previous history of PONV
Apfel score 2	Protocol	Female, non smoker
Apfel score 3	Protocol	Female, non smoker, under 40 years old
Apfel score 1	Protocol	Female

Primary Outcome Measures

Name	Time	Method
Quality of recovery, QoR15 (Quality of Recovery 15)	7 days	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.

Trial Locations

Locations (1)

Danderyds Sjukhus; 🇸🇪 Stockholm, Sweden