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NCT03820479

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

Completed Last updated 10 July 2025
What this trial tests

trial testing Protocol in Quality of Recovery in 98 participants. Completed in 15 May 2024.

Timeline
11 February 2019
Primary endpoint
28 February 2024
15 May 2024

Quick facts

Lead sponsorDanderyd Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment98
Start date11 February 2019
Primary completion28 February 2024
Estimated completion15 May 2024
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Danderyd Hospital

Who can join

Adults 18 to 75, female only, with Quality of Recovery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Quality of Recovery

Currently open trials in the same condition.

Other Danderyd Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03820479.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing