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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

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ClinicalTrials.gov Identifier: NCT03820479
Recruitment Status : Enrolling by invitation
First Posted : January 29, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
EmmaObrink, Danderyd Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Quality of Recovery Other: Protocol

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: An Observational Study to Investigate Quality of Recovery, the Incidence and Impact of Post-Operative Nausea and Vomiting (PONV)/Post-Discharge Nausea and Vomiting (PDNV) up to Day 7 in Females Undergoing Laparoscopic Abdominal Surgery Provided Apfel-score Based PONV Care and Prophylaxis
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Apfel score 1
Female
 Other: Protocol
Best practice of protocol
Apfel score 2
Female, non smoker
 Other: Protocol
Best practice of protocol
Apfel score 3
Female, non smoker, under 40 years old
 Other: Protocol
Best practice of protocol
Apfel score 4
Female, non smoker, under 40 years old, previous history of PONV
 Other: Protocol
Best practice of protocol


Outcome Measures
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Primary Outcome Measures :
  1. Quality of recovery, QoR15 (Quality of Recovery 15) [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female undergoing laparoscopic surgery
Criteria

Inclusion Criteria:

  • ASA class 1-2

Exclusion Criteria:

  • ASA 4, obese
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820479


Locations
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Sweden
Danderyds Sjukhus
Stockholm, Sweden
Sponsors and Collaborators
Danderyd Hospital
More Information
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Additional Information:

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Responsible Party: EmmaObrink, Principal Investigator, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT03820479    
Other Study ID Numbers: DanderydH
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EmmaObrink, Danderyd Hospital:
Quality of recovery
PONV
PDNV