Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000205134
Ethics application status
Approved
Date submitted
8/02/2019
Date registered
12/02/2019
Date last updated
10/12/2020
Date data sharing statement initially provided
12/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Double-blind randomised controlled trial of low pressure vs standard pressure in keyhole surgery for the gallbladder: a study to reduce pain following surgery
Scientific title
Laparoscopic Intra-abdominal Pressure Study comparing pain scores following low and standard pressure in elective laparoscopic cholecystectomy patients: A double blinded randomised controlled trial
Secondary ID [1] 297338 0
Nil known
Universal Trial Number (UTN)
U1111-1228-2242
Trial acronym
LIPS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Gallstones 311464 0
Post-operative Pain 311500 0
Condition category
Condition code
Surgery 310105 310105 0 0
Surgical techniques
Anaesthesiology 310135 310135 0 0
Pain management
Oral and Gastrointestinal 310141 310141 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to answer the question whether it is beneficial to perform laparoscopy at low intra-abdominal pressure in a laparoscopic cholecystectomy operation (keyhole surgery to remove the gallbladder). The two primary objectives of the study are to establish the level of post-operative pain experienced by the patient through both a Likert post-operative pain score and totalling the quantity of opiate analgesia used, and to ensure that there is no compromise to the safety under which the operation is performed.

This will be a double blinded randomised controlled trial with both surgeon and patient blinded to the intra-abdominal pressure used. The intra-abdominal pressures will be randomised to either 8mmHg or 12mmHg. Intra-operative data will be collected in real time (through direct observation by a study investigator including monitoring fidelity to the intervention), and protocols have been designed to protect patient safety in the event that surgeons feel the intra-abdominal view is compromised, which include the ability of the surgeon to increase intra-abdominal pressure to improve the view if required and a limit on pressure increases before the pressure becomes unblinded to all clinicians.
Intervention code [1] 313594 0
Treatment: Surgery
Comparator / control treatment
This will be a double blinded randomised controlled trial with both surgeon and patient blinded to the intra-abdominal pressure used during laparoscopic cholecystectomy. The intra-abdominal pressures will be randomised to either 8mmHg (low pressure) or 12mmHg (standard pressure - the control group). Protocols exist to allow surgeons to increase pressure to allow safe surgery if required.
Control group
Active

Outcomes
Primary outcome [1] 318999 0
The primary outcome is a completed pain score following laparoscopic cholecystectomy. This will be done through a 10 point verbal rating scale.
Timepoint [1] 318999 0
The primary timepoint is 24 hours post-operatively
Secondary outcome [1] 366694 0
The secondary outcome is the number of times the surgeon requests an increase in pressure. This will be measured in real time by a study investigator who is observing the operation.
Timepoint [1] 366694 0
The secondary outcome is at the time of operation.
Secondary outcome [2] 366695 0
The additional secondary outcome is morbidity following operation.
Timepoint [2] 366695 0
Patients will be followed for a minimum of 30 days post-operatively to document any complications. Complications will be assessed by a review of the patient record including discharge summary and the standard 4 week post-operative clinic review.

Eligibility
Key inclusion criteria
All patients at Northern Health undergoing elective laparoscopic cholecystectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any patient undergoing emergency laparoscopic cholecystectomy
• Any patient in whom a second operation is performed
• Any patient under 18 years of age
• Any patient who has a chronic pain syndrome/taking regular opiate medication for non-biliary pain prior to the operation
• Any patient allergic to opiate medication
• Any patient who cannot communicate in English

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)
Allocation is concealed. Randomisation done via computer random number generator and transcribed into sealed envelopes by an investigator not involved in data collection or patient recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A continuous endpoint, two independent sample study power calculation was performed. Assuming that pain scores are 10% higher with standard intra-abdominal pressure laparoscopic cholecystectomy with a standard deviation of 15% of the measures, and assuming a type I error of 0.05 and a type II error of 0.2, power calculations reveal that 86 participants (43 in each group) will give a significant result. Allowing for randomisation and for participant dropout for latter post-operative pain questionnaires, the study is aiming for 100 randomised participants.

Statistical analysis will be performed using Chi-Square for categorical data, and T-test and ANOVA for continuous data. Subset analysis will be performed with groups determined by age, gender, and ASA grade. Decreased post-operative pain will be determined by lower post-operative pain scores between both groups, with secondary measures of analgesia requirement and length of stay used to confirm these findings. Safety of the procedure will be established by a non-significant difference in morbidity and mortality, with secondary measures of length of operation, surgeon satisfaction, and anaesthetic measures used to confirm these findings.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/02/2019
Date of last participant enrolment
Anticipated
Actual
25/09/2019
Date of last data collection
Anticipated
Actual
22/11/2019
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13079 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 25588 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 301901 0
Hospital
Name [1] 301901 0
Northern Health
Country [1] 301901 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
185 Cooper St
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 301665 0
None
Name [1] 301665 0
Address [1] 301665 0
Country [1] 301665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302591 0
Austin Health HREC
Ethics committee address [1] 302591 0
Ethics committee country [1] 302591 0
Australia
Date submitted for ethics approval [1] 302591 0
07/09/2018
Approval date [1] 302591 0
09/11/2018
Ethics approval number [1] 302591 0
HREC/45804/Austin-2018

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

Contacts
Principal investigator
Name 90746 0
Mr Russell Hodgson
Address 90746 0
Division of Surgery
Northern Health
185 Cooper St
Epping VIC 3076
Country 90746 0
Australia
Phone 90746 0
+61 3 84058000
Fax 90746 0
Email 90746 0
[email protected]
Contact person for public queries
Name 90747 0
Russell Hodgson
Address 90747 0
Division of Surgery
Northern Health
185 Cooper St
Epping VIC 3076
Country 90747 0
Australia
Phone 90747 0
+61 3 84058000
Fax 90747 0
Email 90747 0
[email protected]
Contact person for scientific queries
Name 90748 0
Russell Hodgson
Address 90748 0
Division of Surgery
Northern Health
185 Cooper St
Epping VIC 3076
Country 90748 0
Australia
Phone 90748 0
+61 3 84058000
Fax 90748 0
Email 90748 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


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.