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

NCT03820479 | Completed

• 1 other identifier: DanderydH
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Recovery

Keywords

Quality of recovery; PONV; PDNV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Apfel score 1

Female

Other: Protocol

Apfel score 2

Female, non smoker

Other: Protocol

Apfel score 3

Female, non smoker, under 40 years old

Other: Protocol

Apfel score 4

Female, non smoker, under 40 years old, previous history of PONV

Other: Protocol

Interventions

Protocol OTHER

Best practice of protocol

Apfel score 1; Apfel score 2; Apfel score 3; Apfel score 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female undergoing laparoscopic surgery

You may qualify if:

• ASA class 1-2

You may not qualify if:

• ASA 4, obese

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (1)

Danderyds Sjukhus

Stockholm, Sweden

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 29, 2019
• Study Start: February 11, 2019
• Primary Completion: February 28, 2024
• Study Completion: May 15, 2024
• Last Updated: July 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)