Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000240246
Ethics application status
Approved
Date submitted
6/02/2018
Date registered
14/02/2018
Date last updated
25/05/2022
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does stage of menstrual cycle affect recovery after surgery in premenopausal women?
Scientific title
Impact of hormonal cycle on postoperative quality of recovery in premenopausal women.
Secondary ID [1] 293967 0
None
Universal Trial Number (UTN)
Trial acronym
QoRHm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative recovery 306471 0
Menstrual cycle 306473 0
Postoperative nausea and vomiting 306474 0
Postoperative pain management 306476 0
Condition category
Condition code
Anaesthesiology 305571 305571 0 0
Anaesthetics
Anaesthesiology 305572 305572 0 0
Pain management
Reproductive Health and Childbirth 305573 305573 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Our aim is to determine whether stage of hormonal cycle affects quality of recovery after surgery in premenopausal women. Cycle stage will be measured by questionnaire and preoperative sex hormone blood levels. Quality of recovery will be measured by the Quality of Recovery-15 (QoR-15) score on postoperative day 1. Participants will be followed up for 3 days postoperatively (secondary outcome measurement). Our hypothesis is that stage of hormonal cycle affects quality of postoperative recovery in premenopausal women.

Premenopausal women aged 18-45 years undergoing elective surgery will be classified by follicular or luteal phase of menstrual cycle. This will be done by preoperative patient questionnaire and blood progesterone and luteinising hormone levels.
Intervention code [1] 300233 0
Diagnosis / Prognosis
Comparator / control treatment
The two groups to be compared are women in the follicular, and the luteal stage of their menstrual cycle.
Control group
Active

Outcomes
Primary outcome [1] 304696 0
Quality of Recovery-15 score.
The QoR-15 score is a reliable, well-validated, commonly used, multidimensional patient-reported quality of recovery scale. 15 questions assess the domains of pain, physical comfort, physical independence, emotions and psychological support. The continuous scale ranges from 0 (extremely poor recovery) to 150 (excellent recovery).
Quality of Recovery-15 score questions:
1. Able to breathe easily
2. Able to enjoy foods
3. Feeling rested
4. Have had a good sleep
5. Able to look after personal hygiene unaided
6. Able to communicate with family or friends
7. Getting support from hospital doctors and nurses
8. Able to return to work or usual home activities
9. Feeling comfortable and in control
10. Having a feeling of general well being
11. Moderate pain all or nearly all of the time
12. Severe pain at any time
13. Nausea or vomiting
14. Feeling worried or anxious
15. Feeling sad or depressed
Timepoint [1] 304696 0
Postoperative day 1.
Secondary outcome [1] 342826 0
Quality of Recovery-15 score.
Timepoint [1] 342826 0
Postoperative day 3.
Secondary outcome [2] 342827 0
Pain Numeric Rating Score (NRS).
Recorded as the worst NRS at rest, and on movement.
Timepoint [2] 342827 0
Postoperative day 1.
Secondary outcome [3] 342828 0
Subjective Analgesic Effectiveness (SAE) scale.
Patient-reported response to 'How effective was your medication in relieving the pain?'. Ordinal response (poor, fair, good, very good, excellent)
Timepoint [3] 342828 0
Postoperative day 1.
Secondary outcome [4] 342829 0
Postoperative nausea and vomiting Impact Scale (PONV IS).
Patient reported:
Q1. Have you vomited or had dry-retching?
0. No
1. Once
2. Twice
3. Three or more times

Q2. Have you experienced a feeling of nausea (“an unsettled feeling in the stomach and slight urge to vomit”)? If yes, has your feeling of nausea interfered with activities of daily living, such as being able to get out of bed, being able to move about freely in bed, being able to walk normally, or eating and drinking?
0. Not at all
1. Sometimes
2. Often of most of the time
3. All of the time
Timepoint [4] 342829 0
Postoperative day 1.
Secondary outcome [5] 342830 0
Unplanned or prolonged hospital admission due to pain or postoperative nausea and vomiting.
Participants undergoing elective wisdom teeth removal are expected to be discharged on the day of surgery.
Participants undergoing elective laparoscopic cholecystectomy are expected to be discharged on the day after surgery.
Timepoint [5] 342830 0
This will be assessed on day 1 follow up. If a participant has an unplanned or prolonged admission, they will be followed up each day until discharged.

Eligibility
Key inclusion criteria
1. premenopausal women aged 18 to 45 years
2. having a general anaesthetic for elective wisdom teeth extraction or laparoscopic cholecystectomy
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are
1. using hormonal contraception (oral contraceptive pill, hormone-impregnated intrauterine device, subcutaneous implants) or treated with sex hormone therapy for other reasons
2. pregnant or lactating
3. undergone a bilateral oophorectomy
4. known or suspected to be peri- or post-menopausal
5. unable to complete QoR-15 score
6. active cancer
7. systemic disease affecting daily function (ASA 3 or more)
8. contraindication to dexamethasone, current systemic steroid treatment for any reason, insulin-dependent diabetes mellitus
9. regular opioid use
10. previous recruitment in this study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation
A total of 170 women undergoing either minor or intermediate surgery will allow us to detect a minimum clinically important difference of 8 points in the primary outcome QoR-15 score 24 hours postoperatively between women in the follicular phase and women in the luteal phase of their menstrual cycle, with 80% power at the 2-sided 5% level of significance. This assumes an imbalance in sample size between the two surgical groups of 40/60 (i.e. 68 versus 102), an equal standard deviation of 18 points in both groups, and no correlation between the QoR-15 score at admission on the day of surgery and 24 hours postoperatively (conservative). Accounting for about 5% missing data (conservative) in the primary outcome (e.g. due to being either unable or unwilling to complete the QoR-15 24 hours after surgery), a total of 180 participants is required.

Statistical analysis
A detailed statistical analysis plan will be written before start of recruitment. The analysis will include all women who signed informed consent and underwent surgery. All data will be summarized, including missing data. The change in QoR-15 scores from admission on the day of surgery to post-surgery will be analysed using a linear regression model including in the model baseline QoR-15 score (i.e., QoR-15 score on the admission day of surgery) and group (follicular/luteal). To compare both groups, we will obtain an estimate and 95% confidence interval of the absolute difference between the groups in the change from baseline to Day 1 (primary time-point) and Day 3 (secondary time-point). In addition, similar models will be fitted whereby group will be replaced by hormone parameters (e.g. progesterone, luteinising hormone). The shape of the association between hormone parameters and the QoR-15 scores will be examined visually and using fractional polynomials to explore (non-linear) parametrisations.
Associations between the secondary outcomes NRS, SAE, PONV IS, unplanned or prolonged hospital admission due to pain or PONV and group (follicular/luteal) or hormone parameter levels will be investigated. The effect of pre-specified potential confounders (e.g. age, body mass index) will be examined by adjusting for these variables in the model. The difference in effect between the two types of surgery (minor, intermediate) will be explored for all outcomes using a statistical test for interaction. The analysis models will include only observed data (complete case), sensitivity analysis consisting of multiple imputations for handling missing data may be performed; in that case results will be compared with the complete case analysis to investigate robustness of the findings to missing data assumptions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2019
Actual
31/05/2019
Date of last participant enrolment
Anticipated
Actual
29/10/2021
Date of last data collection
Anticipated
Actual
1/11/2021
Sample size
Target
180
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9953 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 18770 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 298599 0
Other
Name [1] 298599 0
Epworth Research Institute
Country [1] 298599 0
Australia
Funding source category [2] 301778 0
Charities/Societies/Foundations
Name [2] 301778 0
Australian and New Zealand College of Anaesthetists Research Foundation
Country [2] 301778 0
Australia
Primary sponsor type
Hospital
Name
Epworth Richmond
Address
89 Bridge Road,
Richmond
Vic 3121
Country
Australia
Secondary sponsor category [1] 297755 0
None
Name [1] 297755 0
Address [1] 297755 0
Country [1] 297755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299561 0
Epworth HREC
Ethics committee address [1] 299561 0
Ethics committee country [1] 299561 0
Australia
Date submitted for ethics approval [1] 299561 0
07/04/2017
Approval date [1] 299561 0
26/06/2017
Ethics approval number [1] 299561 0
EH2017-205
Ethics committee name [2] 302495 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 302495 0
Ethics committee country [2] 302495 0
Australia
Date submitted for ethics approval [2] 302495 0
21/11/2018
Approval date [2] 302495 0
17/12/2018
Ethics approval number [2] 302495 0
691/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80842 0
Dr Nicole Tan
Address 80842 0
Anaesthetic Services
Suite 5.8, The Epworth Centre
32 Erin St
Richmond
Vic 3121
Country 80842 0
Australia
Phone 80842 0
+61 3 9427 7899
Fax 80842 0
Email 80842 0
[email protected]
Contact person for public queries
Name 80843 0
Di Dawson
Address 80843 0
Research Development and Governance Unit
Epworth HealthCare
Ground Floor, 185 Hoddle St
Richmond
Vic 3121
Country 80843 0
Australia
Phone 80843 0
+61 3 9936 8056
Fax 80843 0
Email 80843 0
[email protected]
Contact person for scientific queries
Name 80844 0
Nicole Tan
Address 80844 0
Anaesthetic Services
Suite 5.8, The Epworth Centre
32 Erin St
Richmond
Vic 3121
Country 80844 0
Australia
Phone 80844 0
+61 3 9427 7899
Fax 80844 0
Email 80844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data contains sensitive health data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6511Study protocol  [email protected]
6512Statistical analysis plan  [email protected]
6513Informed consent form  [email protected]
6514Ethical approval  [email protected]
6515Clinical study report  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.