Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000468729
Ethics application status
Not yet submitted
Date submitted
18/04/2013
Date registered
24/04/2013
Date last updated
24/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
In patients having key-hole surgery for appendicitis, does it matter if we use a thorough washout of the contaminated area or just suck out the contamination? This is a study to compare the rates of post-operative infection with the two methods.
Scientific title
In patients undergoing laparoscopic appendicectomy, does the use of suction-only as compared to irrigation-and-suction lead to a decrease in intra-abdominal infections?
Secondary ID [1] 282332 0
Nil
Universal Trial Number (UTN)
U1111-1141-9020
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 288879 0
Condition category
Condition code
Surgery 289221 289221 0 0
Surgical techniques
Oral and Gastrointestinal 289319 289319 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
During laparoscopic appendicectomy, irrigator-suction catheters will be used which irrigate the surgical field with normal saline prior to suction.
Intervention code [1] 286947 0
Treatment: Surgery
Comparator / control treatment
Suction-only catheters will be used which do not perform any irrigation to the surgical field.
Control group
Active

Outcomes
Primary outcome [1] 289335 0
Intra-abdominal abscess. We will search medical records for re-presentations to Emergency or admissions to the surgical unit. Diagnosis of intra-abdominal abscess will be with radiological confirmation (CT or ultrasound) or intra-operative findings at re-operation. Furthermore, a 6-week post-operative phone call will capture any patients who present to their GP or another hospital.
Timepoint [1] 289335 0
6-weeks post-operatively
Secondary outcome [1] 302257 0
Wound infection. We will search medical records for re-presentations to Emergency or admissions to the surgical unit. Furthermore, a 6-week post-operative phone call will capture any patients who present to their GP or another hospital.
Timepoint [1] 302257 0
6-weeks post-operatively
Secondary outcome [2] 302258 0
Duration of surgery - start and end times entered into hospital surgery database.
Timepoint [2] 302258 0
Time of operation

Eligibility
Key inclusion criteria
Adult patients (over 16) in whom appendicectomy is completed laparoscopically and the suppuration is localised to the right iliac fossa, right paracolic gutter or pelvis
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Appendicectomy for normal appendix or non-purulent appendicitis. Interval appendicectomy. Appendicectomy following percutaneous drainage of abscess.

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)
All patients fulfilling the inclusion criteria will be identified by the treating surgical team and enrolled, including informed consent to be enrolled in the trial. Prior to surgery, the surgical team will allocate the patient by drawing a sealed, numbered, opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to either suction-only or irrigation-and-suction by computer-generated random numbers.
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
Statistical methods / analysis
As there is already an RCT in children demonstrating no difference, we have designed an equivalence design for our randomised trial. A sample size calculation was based on a clinically meaningful difference of 15% (calculated from exisiting studies suggesting abscess rates of 3.5% and 18.5% for the different groups - 18.5-3.5% = 15%). This resulted in a sample size of 61 patients per group. Allowing for protocol violation and loss to follow up, we will include 70 patients per group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2013
Actual
Date of last participant enrolment
Anticipated
31/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 892 0
Western Hospital - Footscray
Recruitment hospital [2] 893 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 6692 0
3011 - Footscray
Recruitment postcode(s) [2] 6693 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 287090 0
Hospital
Name [1] 287090 0
Western Hospital
Country [1] 287090 0
Australia
Primary sponsor type
Individual
Name
Prof Steven Chan
Address
Sunshine Hospital, Furlong Rd, St Albans, VIC, 3021
Country
Australia
Secondary sponsor category [1] 285866 0
None
Name [1] 285866 0
Address [1] 285866 0
Country [1] 285866 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289106 0
Western Health Ethics Committee
Ethics committee address [1] 289106 0
Western Health Office for Research
Level 3
Sunshine Hospital
Furlong Rd
St Albans, VIC, 3021
Ethics committee country [1] 289106 0
Australia
Date submitted for ethics approval [1] 289106 0
05/05/2013
Approval date [1] 289106 0
Ethics approval number [1] 289106 0
Pending

Summary
Brief summary
Laparoscopic appendicectomy is one of the most commonly performed urgent abdominal operations. Current practices of Irrigation or Suction-only are largely determined by individual surgeon’s bias based on intra-operative findings. To date, there is only one randomized, controlled trial comparing irrigation with suction only in children and none in adults. There is some retrospective data in children and adults. All of the existing data suggests “no difference” between these operative methods; in fact, some retrospective data suggest higher intra-abdominal abscess rates in irrigation groups, however there has never been a randomized trial in adults. There remains clinical equipoise and current practice is widely varied.
Our hypothesis is that there is no difference between the two surgical methods and we aim to demonstrate that it doesn't matter to the patient which method is used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39258 0
Prof Steven Chan
Address 39258 0
Sunshine Hospital
Furlong Rd, St Albans, VIC, 3021
Country 39258 0
Australia
Phone 39258 0
(+61) 3 83456666
Fax 39258 0
Email 39258 0
stfc@unimelb.edu.au
Contact person for public queries
Name 39259 0
Dr Hayden Snow
Address 39259 0
Western Hospital
Gordon St
Footscray, VIC, 3011
Country 39259 0
Australia
Phone 39259 0
(+61) 3 83456666
Fax 39259 0
Email 39259 0
haydensnow@me.com
Contact person for scientific queries
Name 39260 0
Prof Steven Chan
Address 39260 0
Sunshine Hospital
Furlong Rd, St Albans, VIC, 3021
Country 39260 0
Australia
Phone 39260 0
(+61) 3 83456666
Fax 39260 0
Email 39260 0
stfc@unimelb.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseIrrigation versus suction alone during laparoscopic appendectomy; A randomized controlled equivalence trial.2016https://dx.doi.org/10.1016/j.ijsu.2016.01.099
N.B. These documents automatically identified may not have been verified by the study sponsor.