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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
trial testing Protocol in Quality of Recovery in 98 participants. Completed in 15 May 2024.
28 February 2024
Quick facts
| Lead sponsor | Danderyd Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 98 |
| Start date | 11 February 2019 |
| Primary completion | 28 February 2024 |
| Estimated completion | 15 May 2024 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Protocol
Conditions studied
- Quality of Recovery — all drugs for Quality of Recovery →
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.
Verify or expand the search:
- PubMed search for NCT03820479
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Related trials
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Currently open trials in the same condition.
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Other Danderyd Hospital trials
Trials by the same sponsor.
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- NCT07476703 — Expanded Studies on the SCAPIS Stockholm Reexamination Cohort · recruiting
- NCT05359367 — A Novel Approach to Enhance True Recovery After Stroke · terminated
- NCT06734247 — Arterial Stiffness for Improved Prediction of Coronary Artery Disease by Coronary CT Angiography · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03820479 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Danderyd Hospital
- Last refreshed: 10 July 2025
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