## Protocol Section
### Identification Module
**NCT ID:** NCT03820479

**Brief Title:** 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

**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

#### Organization Study ID Info
**ID:** DanderydH
#### Organization
**Class:** OTHER
**Full Name:** Danderyd Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-06

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-02-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-02-11

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2019-01-29
**Type:** ACTUAL
**Study First Submit Date:** 2019-01-23
**Study First Submit QC Date:** 2019-01-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Danderyd Hospital

#### Responsible Party

**Investigator Affiliation:** Danderyd Hospital

**Investigator Full Name:** EmmaObrink

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Quality of Recovery

**Keywords:**

- Quality of recovery

- PONV

- PDNV

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 7 Days

### Arms Interventions Module

#### Arm Group 1

**Description:** Female

**Intervention Names:**

- Other: Protocol

**Label:** Apfel score 1

#### Arm Group 2

**Description:** Female, non smoker

**Intervention Names:**

- Other: Protocol

**Label:** Apfel score 2

#### Arm Group 3

**Description:** Female, non smoker, under 40 years old

**Intervention Names:**

- Other: Protocol

**Label:** Apfel score 3

#### Arm Group 4

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

**Intervention Names:**

- Other: Protocol

**Label:** Apfel score 4

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Apfel score 1

- Apfel score 2

- Apfel score 3

- Apfel score 4

**Description:** Best practice of protocol

**Name:** Protocol

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Quality of recovery, QoR15 (Quality of Recovery 15)

**Time Frame:** 7 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA class 1-2

Exclusion Criteria:

* ASA 4, obese

**Gender Based:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Female undergoing laparoscopic surgery

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Danderyds Sjukhus

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12273

- Name: Nausea

- Relevance: LOW

- As Found: Unknown

- ID: M17582

- Name: Vomiting

- Relevance: LOW

- As Found: Unknown

- ID: M22074

- Name: Postoperative Nausea and Vomiting

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
