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Trial registered on ANZCTR


Registration number
ACTRN12622001298707
Ethics application status
Approved
Date submitted
30/09/2022
Date registered
6/10/2022
Date last updated
16/11/2023
Date data sharing statement initially provided
6/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can we reduce pain and improve mobility after keyhole surgery for removal of the gallbladder by enhancing intraoperative care?
Scientific title
A Randomised Controlled Clinical Trial To Assess Low Versus Standard
Intra-Abdominal Insufflation Pressure in Patients Undergoing Laparoscopic
Cholecystectomy and the Effect on Pre and Post-Operative Spirometry
Secondary ID [1] 308061 0
None
Universal Trial Number (UTN)
Trial acronym
SpiroFun
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cholelithiasis 327753 0
post-operative pain 327754 0
Condition category
Condition code
Oral and Gastrointestinal 324824 324824 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 324825 324825 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-Low pressure (7-10mmHg), warmed (37 degrees Celsius) and humidified carbon dioxide (98% relative humidity)-pneumoperitoneum during the operative procedure for approximately 40-60 minutes. Procedure takes approximately 1 hour with or without interventions.
-The use of instilled intraperitoneal local anaesthetic 2mg/kg of 0.5% bupivacaine- prior to the removal of the gallbladder . This is in addition to the local anaesthetic infiltration into laparoscopic port sites using 2mg/kg bupivacaine given prior to port placement.
-An anaesthetic lung recruitment manoeuvre of delivering a large breath via the endotracheal tube by the Anaesthestist at the end of the operative procedure prior to reversal of anaesthesia.
Intervention code [1] 324528 0
Treatment: Drugs
Intervention code [2] 324529 0
Treatment: Other
Comparator / control treatment
-Use of local anasethetic infiltration into laparoscopic port sites - bupivacaine (standard treatment)
Control group
Active

Outcomes
Primary outcome [1] 332654 0
Forced expiratory volume in 1 second (FEV1) via spirometry.
Timepoint [1] 332654 0
Pre-operatively and 4-8 hours post-operatively whilst in hospital.
Secondary outcome [1] 414253 0
Forced vital capacity (FVC) via spirometry.
Timepoint [1] 414253 0
Pre-operatively and 4-8 hours post-operatively whilst in hospital.
Secondary outcome [2] 414254 0
DeMorton Mobility Index (DEMMI) Score
Timepoint [2] 414254 0
Pre-operatively and 4-8 hours postoperatively.
Secondary outcome [3] 414255 0
Visual Analog Score (VAS) for pain
Timepoint [3] 414255 0
Post-operatively 4-8 hours whilst in hospital.
Secondary outcome [4] 414256 0
Opioid analgesic total dose (oral morphine milliequivalents)
Timepoint [4] 414256 0
Given in hospital as recorded in the medical record at the time of discharge.
Secondary outcome [5] 414257 0
Surgical complications defined by the Clavien-Dindo Classification
Timepoint [5] 414257 0
Assesed by day 30 post-operatively by review of the medical record and phone follow-up with the patient.
Secondary outcome [6] 414258 0
Patient self-reported Quality of Recovery Questionnaire (QoR-15) scores
Timepoint [6] 414258 0
Pre-operatively and day 1 post-operatively.
Secondary outcome [7] 414259 0
Rate of conversion from low pressure to high pressure pneumoperitoneum as recorded in the operative report.
Timepoint [7] 414259 0
Assessed by review of medical record operative report at discharge.
Secondary outcome [8] 414260 0
Incidence of shoulder tip pain identified by review of medical record.
Timepoint [8] 414260 0
Review of medical record at discharge,
Secondary outcome [9] 414261 0
Length of operation time assessed by review of medical record.
Timepoint [9] 414261 0
At the time of discharge,

Eligibility
Key inclusion criteria
All English-speaking patients 18 years and over undergoing elective laparoscopic cholecystectomy at participating institutions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Are unable to give written informed consent to take part in the study,
-Patients who require the use of a trained healthcare interpreter to be able to understand study information.
-Unable to carry out spirometry or mobility assessment
-Long term opioid use
-BMI > 35kg/m2
-Significant lung disease with FEV1 <1.25L
-Previous upper abdominal laparotomy suggestive of prolonged, complex upper abdominal surgery/ adhesiolysis
-Past abdominoplasty, abdominal wall reconstruction, component separation
-Known allergies to local anaesthetic or opioid agents.
-Known chronic pain syndrome
-Diagnosed neuromuscular disease
-Previous necrotizing pancreatitis
-Known stage 4 chronic kidney disease of eGFR 15-29ml/min.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Outcome assessors to be blinded to treatment allocation.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previous study, we assume the standard deviation of FEV1 is 0.84L and the mean for the usual care group is 2L. A sample size of 125 per arm will give the study 80% power to detect a clinically relevant difference of 300mL in mean FEV1 between the two arms, with a type 1 error rate of 5%. Allowing for 10% attrition, a sample size of 280 patients in total are needed for the study.
The analysis of the efficacy endpoint will be in the full analysis set, and include all participants that were randomised in the study. The analysis will follow the intention to treat principle, analysing patients according to the treatment they were randomised to receive.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/10/2022
Actual
1/03/2023
Date of last participant enrolment
Anticipated
27/09/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
280
Accrual to date
63
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23267 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 23268 0
Belmont Hospital - Belmont
Recruitment hospital [3] 23269 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [4] 23270 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 38636 0
2305 - New Lambton
Recruitment postcode(s) [2] 38637 0
2280 - Belmont
Recruitment postcode(s) [3] 38638 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 38639 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 312319 0
Government body
Name [1] 312319 0
Hunter New England Local Health District
Country [1] 312319 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 313896 0
None
Name [1] 313896 0
Address [1] 313896 0
Country [1] 313896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311686 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 311686 0
Ethics committee country [1] 311686 0
Australia
Date submitted for ethics approval [1] 311686 0
30/08/2022
Approval date [1] 311686 0
28/09/2022
Ethics approval number [1] 311686 0
2022ETH01661

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

Contacts
Principal investigator
Name 121994 0
Dr David Burnett
Address 121994 0
Surgical Services
John Hunter Hospital
Lookout Road
New Lambton Heights
NSW 2305
Country 121994 0
Australia
Phone 121994 0
+61 02 49236397
Fax 121994 0
Email 121994 0
HNELHD-SurgeryResearch@health.nsw.gov.au
Contact person for public queries
Name 121995 0
Rosemary Carroll
Address 121995 0
Surgical Services
John Hunter Hospital
Lookout Road
New Lambton Heights
NSW 2305
Country 121995 0
Australia
Phone 121995 0
+61 02 49236397
Fax 121995 0
Email 121995 0
HNELHD-SurgeryResearch@health.nsw.gov.au
Contact person for scientific queries
Name 121996 0
David Burnett
Address 121996 0
Surgical Services
John Hunter Hospital
Lookout Road
New Lambton Heights
NSW 2305
Country 121996 0
Australia
Phone 121996 0
+61 02 49236397
Fax 121996 0
Email 121996 0
HNELHD-SurgeryResearch@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All outcome data
When will data be available (start and end dates)?
After publication of study results. No end date.
Available to whom?
Approved researchers
Available for what types of analyses?
meta-analysis
How or where can data be obtained?
HNELHD-SurgeryResearch@health.nsw.gov.au


What supporting documents are/will be available?

No Supporting Document Provided



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.