Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000341628
Ethics application status
Approved
Date submitted
27/02/2023
Date registered
31/03/2023
Date last updated
2/11/2023
Date data sharing statement initially provided
31/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Nasogastric Tubes in Adult Patients with Small Bowel Obstruction
Scientific title
A Randomised Clinical Trial to Assess the Use of Nasogastric Tubes in Adult Patients with Adhesive Small Bowel Obstruction for Prevention of Operative Intervention.
Secondary ID [1] 293410 0
Protocol Number JHHGIS020
Universal Trial Number (UTN)
Trial acronym
SBO Study - NASBO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
small bowel obstruction 329152 0
intestinal obstruction 329153 0
Condition category
Condition code
Oral and Gastrointestinal 326131 326131 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
No nasogastric tube, in addition to standard care which may include intravenous fluids, analgesia, anti-emetics, and/or surgery as determined by surgeon in charge based on progress of signs and symptoms of bowel onstruction including radiological changes.
Adherence to ransomisation will be recorded from the medical record.
Intervention code [1] 325532 0
Treatment: Other
Comparator / control treatment
Nasogastric tube- placement of nasogastric tube within 6 hours of arrival at hospital, via the nose into the body of the stomach to remove contents and relieve gastric distension and with follow-up chest X-ray to confirm appropriate positioning of the nasogastric tube. In addition to standard care which may include intravenous fluids, analgesia, anti-emetics, and/or surgery as determined by surgeon in charge based on progress of signs and symptoms of bowel onstruction including radiological changes. NG tube removal will be at the discretion of the treating surgeon.
Adherence to randomisation will be recorded from the medical record.
Control group
Active

Outcomes
Primary outcome [1] 333996 0
Rate of operation
Timepoint [1] 333996 0
Day 30 after admission as assessed by review of medical record.
Secondary outcome [1] 419010 0
Mean time to operation as assessed by review of the medical record.
Timepoint [1] 419010 0
By day 30 post discharge..
Secondary outcome [2] 419011 0
Rate of return to the operating theatre after initial operative procedure as assessed by review of the medical record by day 30.
Timepoint [2] 419011 0
By day 30 post dishcarge.
Secondary outcome [3] 419012 0
Mean length of hospital stay (LOS) assessed at day 90.
Timepoint [3] 419012 0
By review of the medical record at day 90 post discharge.
Secondary outcome [4] 419013 0
Rate of admission to intensive care as assessed by review of the medical record.
Timepoint [4] 419013 0
By day 90 post discharge.
Secondary outcome [5] 419014 0
Mean LOS for patients admitted to ICU as assessed by review of the medical record.
Timepoint [5] 419014 0
By day 90 post discharge.
Secondary outcome [6] 419015 0
Incidence of surgical complications (Clavien-Dindo classification) by review of the medical record and self-reported by participant via phone follow-up. Complications may include but not limited to deep vein thrombosis, pulmoney embolus, surgical site infection, aspiration pneumonia.
Timepoint [6] 419015 0
Identified by day 30 post discharge by review of the medical record and self-reported by the patient at day 30 follow-up post discharge
Secondary outcome [7] 419016 0
Incidence of post-operative pulmonary complications as graded by the Melbourne Group Scale using the medical record. These may inlcude chest x-ray report of collapse/consolidation, production of yellow or green sputum different to preoperative assessment, presciption of antibiotic for a respiratory infection.
Timepoint [7] 419016 0
By Day 30 post discharge.
Secondary outcome [8] 419017 0
Incidence of NG tube complications up to time of removal as recorded in the medical record including but not limited to, displacement, pressure areas on nares, gastric erosion.
Timepoint [8] 419017 0
Up to day 90 post discharge..
Secondary outcome [9] 419018 0
Quality of Life patient reported outcome using the EQ-5D-5L..
Timepoint [9] 419018 0
Measured at admission within 24 hours and at days 30 and 90 post discharge.
Secondary outcome [10] 420285 0
Rate of use of low continuous suction applied to nasogastric tube.
Timepoint [10] 420285 0
Assessed by review of medical record after hospital discharge
Secondary outcome [11] 420286 0
Rate of use of gastrograffin
Timepoint [11] 420286 0
Assessed by review of the medication record after hospital discharge.

Eligibility
Key inclusion criteria
• Patients 18 years and over.
• Past history of abdominal surgery.
• Radiological evidence of small bowel obstruction.
• Direct presentation to the hospital from home or usual place for residence.
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, or do not have a designated person responsible that can provide consent until the participant is well enough to consent for themselves.
• Patients who require the use of a trained healthcare interpreter and present after hours when a trained health care interpreter may not be available in a timely manner.
• Patients readmitted with SBO within follow-up time-points of study.
• Patients transferred from other hospitals
• Patient who has had a nasogastric tube inserted by other staff prior to surgical review, eg Emergency Department Senior Medical officer.
• Known malignancies that may cause obstruction.
• Radiological evidence of a mass lesion causing obstruction.
• Obstruction caused by hernias.
• Radiological evidence of need for urgent surgery based on ischaemic small intestine.
• Pregnant females.
• Recent history of aspiration pneumonia
• Patients not considered to have a survivable condition.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/10/2023
Actual
1/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24144 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 24145 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 39656 0
2305 - New Lambton
Recruitment postcode(s) [2] 39657 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 313291 0
Hospital
Name [1] 313291 0
John Hunter Hospital
Country [1] 313291 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] 315029 0
None
Name [1] 315029 0
Address [1] 315029 0
Country [1] 315029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299063 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299063 0
Ethics committee country [1] 299063 0
Australia
Date submitted for ethics approval [1] 299063 0
27/02/2023
Approval date [1] 299063 0
28/03/2023
Ethics approval number [1] 299063 0

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

Contacts
Principal investigator
Name 79162 0
Prof Stephen Smith
Address 79162 0
Surgical Services
Calvary Mater Newcastle
Edith St
Waratah NSW 2298
Country 79162 0
Australia
Phone 79162 0
+61 02 49236392
Fax 79162 0
Email 79162 0
[email protected]
Contact person for public queries
Name 79163 0
Rosemary Carroll
Address 79163 0
Surgical Services,
John Hunter Hospital,
Locked Bag 1 HRMC 2310
Country 79163 0
Australia
Phone 79163 0
+61 02 49236397
Fax 79163 0
Email 79163 0
[email protected]
Contact person for scientific queries
Name 79164 0
Stephen Smith
Address 79164 0
Surgical Services
Calvary Mater Newcastle
Edith St
Waratah NSW 2298
Country 79164 0
Australia
Phone 79164 0
+61 02 49236392
Fax 79164 0
Email 79164 0
[email protected]

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 collected data
When will data be available (start and end dates)?
Post-publication for 3 years.
Available to whom?
Other surgical researchers.
Available for what types of analyses?
Meta-analysis or systematic review
How or where can data be obtained?
[email protected]


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.