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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 287090 0
Western Hospital
Address [1] 287090 0
Gordon St, Footscray, VIC, 3011
Country [1] 287090 0
Primary sponsor type
Prof Steven Chan
Sunshine Hospital, Furlong Rd, St Albans, VIC, 3021
Secondary sponsor category [1] 285866 0
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
Date submitted for ethics approval [1] 289106 0
Approval date [1] 289106 0
Ethics approval number [1] 289106 0

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

Principal investigator
Name 39258 0
Prof Steven Chan
Address 39258 0
Sunshine Hospital
Furlong Rd, St Albans, VIC, 3021
Country 39258 0
Phone 39258 0
(+61) 3 83456666
Fax 39258 0
Email 39258 0
Contact person for public queries
Name 39259 0
Dr Hayden Snow
Address 39259 0
Western Hospital
Gordon St
Footscray, VIC, 3011
Country 39259 0
Phone 39259 0
(+61) 3 83456666
Fax 39259 0
Email 39259 0
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
Phone 39260 0
(+61) 3 83456666
Fax 39260 0
Email 39260 0

No information has been provided regarding IPD availability
Summary results
No Results