Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000187640
Ethics application status
Approved
Date submitted
13/02/2023
Date registered
22/02/2023
Date last updated
22/02/2023
Date data sharing statement initially provided
22/02/2023
Date results information initially provided
22/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral premedication absorption during bariatric surgery
Scientific title
The transit of oral premedication beyond the stomach in patients undergoing laparoscopic sleeve gastrectomy
Secondary ID [1] 308987 0
None
Universal Trial Number (UTN)
U1111-1288-4310
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bariatric surgery 329011 0
Absorption of premedications 329012 0
Condition category
Condition code
Surgery 325993 325993 0 0
Surgical techniques
Oral and Gastrointestinal 325994 325994 0 0
Normal oral and gastrointestinal development and function
Anaesthesiology 325995 325995 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective analysis of patients who underwent laparoscopic gastric sleeve resection between July 2020 and May 2022 and received oral premedication (tapentadol - slow release and netupitant/palonosetron) as part of their bariatric surgery program. All data were collected during review of the patients' medical records.

The presence and physical state of medications at the time of gastric sleeve resection were recorded.

Patients were then stratified into two groups:
1. Transit group (premedication not seen in the stomach or resection specimen)
2. Failure-to-Transit group (premedication present in the resection specimen).

We evaluated whether age, sex, body mass index, and diabetes mellitus were associated with the presence or absence of oral premedication in the stomach or resected gastric specimen.

The association between the time that the premedications were administered orally and the time that the gastric specimen was resected i.e., the premedication lead time, and the presence or absence of premedication in the specimen was evaluated.

Intervention code [1] 325429 0
Early Detection / Screening
Comparator / control treatment
The comparator group will be patients in the "Transit group". This is the group where the premedication is not visualised in the stomach or resection specimen.
Control group
Active

Outcomes
Primary outcome [1] 333850 0
Presence or absence of oral premedication in the stomach or sleeve resection specimens
Timepoint [1] 333850 0
This will be assessed intraoperatively when the resected gastric specimen is removed. This outcome will be sourced from the operation report in the patient medical records.
Secondary outcome [1] 418471 0
The patients's body mass index
Timepoint [1] 418471 0
This will be assessed by a review of the patient's preoperative medical records on arrival in the hospital .

Secondary outcome [2] 418472 0
The age of the patient in years.
Timepoint [2] 418472 0
This will be assessed by a review of the patient's preoperative medical records on arrival in the hospital.
Secondary outcome [3] 418748 0
The presence of diabetes mellitus.
Timepoint [3] 418748 0
This will be assessed by a review of the patient's preoperative medical records on arrival in the hospital.
Secondary outcome [4] 418749 0
Premedication lead time, defined as the time in minutes from when the premedication tablets were administered orally to when the gastric sleeve was resected. This will be determined by a review of surgical operation report found in the medical records.
Timepoint [4] 418749 0
Measurement will commence when the premedication is administered and measurement will end at the timepoint when the gastric specimen has been removed.

Eligibility
Key inclusion criteria
We will include the following patients:

1. Aged 18 years or older
2. Undergoing bariatric sleeve gastrectomy between July 2020 and May 2022 for weight loss 3. Received oral premedication as part of their anaesthesia protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude the following patients

1. Patients undergoing non-resectional procedures including Roux-en-Y gastric bypass, single anastomosis gastric bypass, laparoscopic gastric banding, revisional bariatric surgery
2. Patients on any prokinetic medications
3. Patients those who did not receive premedications.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using R system version 4.2.1 (R Core Team, 2022, R: A language and environment for statistical computing, Vienna, Austria).

Patients will be divided into two categorical groups: failure-to-transit and transit groups. Continuous variables will be evaluated for normality using the Shapiro-Wilk test. The Mann-Whitney test, Chi-square test, and Cochran–Armitage test for trends will be used to compare demographic and preoperative information between groups. The relationship between this information and groups will be evaluated using Spearman’s correlation analysis.

Kaplan-Meier survival analysis will be applied to estimate the relationship between medication lead time and the presence (failure-to-transit group) or absence (transit group) of premedication in the gastric sleeve specimen after resection. The event will be defined as the absence of medication in the surgical specimen (i.e., in the removed sleeve resection), and the presence of medication in the specimen will be considered as a censored case.

Observation time will be defined using premedication lead time. Response rates of 50% (median) and 80% complete absorption times will be estimated with the corresponding 95% confidence intervals. The proportional hazard assumption will be evaluated using a log-log plot, and a Log-rank test will be applied to compare the survival curves.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/03/2022
Date of last participant enrolment
Anticipated
Actual
31/05/2022
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
158
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24035 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 24037 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 39531 0
3084 - Heidelberg
Recruitment postcode(s) [2] 39533 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 313200 0
Hospital
Name [1] 313200 0
Austin Health - Austin Hospital - Heidelberg
Country [1] 313200 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Austin Hospital - Heidelberg
Address
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 314917 0
None
Name [1] 314917 0
Address [1] 314917 0
Country [1] 314917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312432 0
Austin Health Research Ethics Committee
Ethics committee address [1] 312432 0
Level 8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
Ethics committee country [1] 312432 0
Australia
Date submitted for ethics approval [1] 312432 0
20/02/2020
Approval date [1] 312432 0
23/03/2020
Ethics approval number [1] 312432 0
HREC/91061/Austin

Summary
Brief summary
Prophylactic antiemetic and analgesic oral premedications are frequently prescribed preoperatively to enhance recovery after laparoscopic gastric sleeve resection. However, it is unknown whether these medications transit beyond the stomach or if they remain in the stomach or sleeve resection specimen, thereby negating their pharmacological effects.

The purpose of this study is to identify whether age, sex, body mass index, and diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen.

Who is it for?

The study will include adult patients undergoing bariatric surgery. This is a retrospective analysis of patients who underwent laparoscopic gastric sleeve resection who received premedications as part of usual anaesthesia and surgical care.

Study details

This study will evaluate the presence or absence of oral premedication in the stomach or sleeve resection specimens. The secondary aims will be to to evaluate whether age, sex, body mass index, or diabetes mellitus are associated with the presence or absence of oral premedication in the stomach or resected gastric specimen. Finally, the study will evaluated the association between premedication lead time and the presence or absence of premedication in the specimen. Premedication lead time is defined as the time in minutes from when the premedication tablets were administered orally to when the gastric sleeve was resected.

It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the timing of premedication before bariatric surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124646 0
Prof Laurence Weinberg
Address 124646 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 124646 0
Australia
Phone 124646 0
+61 394965429
Fax 124646 0
+61394966421
Email 124646 0
laurence.weinberg@austin.org.au
Contact person for public queries
Name 124647 0
Prof Laurence Weinberg
Address 124647 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 124647 0
Australia
Phone 124647 0
+61 394965429
Fax 124647 0
+61394966421
Email 124647 0
laurence.weinberg@austin.org.au
Contact person for scientific queries
Name 124648 0
Prof Laurence Weinberg
Address 124648 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 124648 0
Australia
Phone 124648 0
+61 394965429
Fax 124648 0
+61394966421
Email 124648 0
laurence.weinberg@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given that this is a retrospective review, participants have not consented to sharing of their data.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18333Statistical analysis plan  laurence.weinberg@austin.org.au
18334Study protocol  laurence.weinberg@austin.org.au


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18333Statistical analysis plan  laurence.weinberg@austin.org.au
18334Study protocol  laurence.weinberg@austin.org.au
23760Ethical approval  laurence.weinberg@austin.org.au 385397-(Uploaded-14-07-2023-16-51-05)-Study-related document.pdf

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.