Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000017921
Ethics application status
Approved
Date submitted
10/11/2019
Date registered
14/01/2020
Date last updated
31/10/2022
Date data sharing statement initially provided
14/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Peritoneal Lavage Influence the Rate of Complications in Paediatric Laparoscopic Appendicectomy? A Prospective Multisite Randomised Controlled Trial
Scientific title
Does Peritoneal Lavage Influence the Rate of Complications in Paediatric Laparoscopic Appendicectomy? A Prospective Multisite Randomised Controlled Trial
Secondary ID [1] 300089 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SWAP- Suction vs Washout for Appendicectomy in the Paediatric population
Linked study record
Nataraja RM, Panabokke G, Chang AD, Mennie N, Tanny ST, Keys C, Cheng W et al. Does Peritoneal Lavage Influence the Rate of Complications Following Pediatric Laparoscopic Appendicectomy in Children with Complicated Appendicitis? A Prospective Randomized Clinical Trial. JPS [Internet]. 2019 Sep [cited 2019 Oct 14];54(9)1-4. Available from: https://www.jpedsurg.org/article/S0022-3468(19)30579-2/fulltext DOI: https://doi.org/10.1016/j.jpedsurg.2019.08.039
Pilot study for the current trial

Health condition
Health condition(s) or problem(s) studied:
Appendicitis (Complex) 314615 0
Condition category
Condition code
Surgery 312954 312954 0 0
Surgical techniques
Oral and Gastrointestinal 313903 313903 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
Peritoneal lavage, an intraoperative technique, will be used in the intervention/exposure group. Peritoneal lavage as a technique involves the peritoneal cavity being lavaged (flushed) with
a minimum of 2000ml of saline solution and then suctioned to remove the fluid. This is a routine surgical technique with the purpose of removing contaminants (from the perforated appendix) from the peritoneal cavity. This occurs once at the end of the procedure and will be conducted by the surgeon and/ or the surgical assistant.
Intervention code [1] 315676 0
Treatment: Other
Comparator / control treatment
Our comparator will involve an alternative accepted surgical technique to peritoneal lavage: suction of contaminants from the peritoneal cavity without the use of peritoneal lavage or fluid washout of any kind ( we have defined this as using a maximum amount of 100ml of saline solution).
Control group
Active

Outcomes
Primary outcome [1] 321538 0
Development of intra-abdominal abscess.
As determined by symptoms of recurrent pain and tenderness (reported by the patient), temperature >38, raised inflammatory markers and ultrasound evidence of an intra abdominal collection.
Timepoint [1] 321538 0
Assessment for intra-abdominal abscess will occur during the initial inpatient period, starting immediately post-operation and ending when the patient is discharged (primary timepoint)
Assessment for intra-abdominal abscess will occur during the routine outpatient appointment four to eight weeks post-discharge
Secondary outcome [1] 375277 0
Development of acute small bowel obstruction.
Determined by symptoms of vomiting and abdominal pain (as reported by the patient) and diagnosis on plain abdominal X-ray.
Timepoint [1] 375277 0
Assessment for small bowel obstruction will occur during the initial inpatient period, immediately post-operation and until the patient is discharged
Assessment for small bowel obstruction will occur during the routine outpatient appointment four to eight weeks post-discharge
Secondary outcome [2] 375278 0
Length of inpatient stay in days from the surgical intervention time to discharge from hospital. Length of inpatient stay will be assessed through data collected from the patient's hospital record.
Timepoint [2] 375278 0
Discharge time from initial inpatient stay.
Secondary outcome [3] 375279 0
Development of surgical wound infection. This will be defined as the presence of erythema and the discharge of purulent material from the wound after being assessed by a medical practitioner. This will be assessed through data collected from hospital records during the patient's inpatient stay and outpatient clinic visits, as well as clinical assessment of the patient during their follow-up outpatient clinic appointment.
Timepoint [3] 375279 0
Assessment for wound infection will occur during the initial inpatient period, immediately post-operation and until the patient is discharged
Assessment for wound infection will occur during the routine outpatient appointment four to eight weeks post-discharge
Secondary outcome [4] 375280 0
Analgesia requirement during the inpatient stay (as a composite outcome) - type of analgesia, number of doses and discharge medications. This will be assessed through hospital records during the patient's inpatient stay, as well as patient-reported during the follow-up outpatient clinic visit.
Timepoint [4] 375280 0
Assessment for analgesia use will occur during the initial inpatient period, immediately post-operation and until time of patient discharge
Assessment for analgesia use will occur during the routine outpatient appointment four to eight weeks post-discharge

Eligibility
Key inclusion criteria
- Four to 16 years of age (inclusive)
- Complex appendicitis (as diagnosed by the surgeon intra-operatively), defined by widespread purulent tissue in the peritoneal cavity and/or evidence of a perforated appendix.
- No major co-morbidities that may lead to higher likelihood of postoperative complications
- Laparoscopic appendicectomy
Minimum age
4 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients or parents/ legal guardians of patients unwilling to participate in the study
- Absence of complex appendicitis as a diagnosis
- Conversion of laparoscopic appendicectomy to open procedure

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)
Randomization will be provided in association with the department of human research and biostatistics at Monash University using a randomly-generated sequence in opaque envelopes. Allocation concealment will be ensured as a third party will disclose to the operating surgeon which group each patient will be allocated to (theatre nurse).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SNOSE method
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
Results will be analysed after data extraction with dedicated statistical software. Data will be expressed as mean ± SD, median (range), interquartile range (IQR), count number, or percentages, as indicated. The D’Agostino and Pearson normality test will be used to evaluate the normal distribution of continuous variables. Unpaired Student’s t, Mann–Whitney U, Chi-squares, or Fischer’s exact test will be used where appropriate to identify differences between the two groups for continuous or categorical variables. Multiple regression analysis will be used to identify factors leading to IAA formation post-operatively. Sub analysis will be performed to look for difference in incidence of IAA according to the type of the antibiotic therapy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
21/04/2020
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
1232
Accrual to date
135
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 14883 0
Monash Children’s Hospital - Clayton
Recruitment hospital [2] 20964 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 20966 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 20967 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 28150 0
3168 - Clayton
Recruitment postcode(s) [2] 35796 0
3052 - Parkville
Recruitment postcode(s) [3] 35798 0
2031 - Randwick
Recruitment postcode(s) [4] 35799 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303817 0
Hospital
Name [1] 303817 0
Monash Children's Hospital
Country [1] 303817 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton Road, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 304085 0
None
Name [1] 304085 0
Address [1] 304085 0
Country [1] 304085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304331 0
Monash Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 304331 0
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 304331 0
Australia
Date submitted for ethics approval [1] 304331 0
13/11/2019
Approval date [1] 304331 0
05/02/2020
Ethics approval number [1] 304331 0
RES-19-0000-885A

Summary
Brief summary
Appendicitis which is perforated has a high complication rate in children. To decrease this some surgeons use a washout to remove the purulent fluid whilst others don't, and there is conflicting evidence as to which is best. Our aim is to investigate this to improve the care and outcomes of children with this common condition
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96570 0
A/Prof Ram Nataraja
Address 96570 0
Monash Children's Hospital
246 Clayton Road
Clayton VIC 3168
Country 96570 0
Australia
Phone 96570 0
+61450608213
Fax 96570 0
Email 96570 0
[email protected]
Contact person for public queries
Name 96571 0
Miss Samantha Leng
Address 96571 0
Monash Children's Hospital
246 Clayton Road
Clayton VIC 3168
Country 96571 0
Australia
Phone 96571 0
+61432749213
Fax 96571 0
Email 96571 0
[email protected]
Contact person for scientific queries
Name 96572 0
Miss Samantha Leng
Address 96572 0
Monash Children's Hospital
246 Clayton Road
Clayton VIC 3168
Country 96572 0
Australia
Phone 96572 0
+61432749213
Fax 96572 0
Email 96572 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5111Study protocol    378378-(Uploaded-04-11-2019-20-23-53)-Study-related document.docx
5112Informed consent form    378378-(Uploaded-04-11-2019-20-26-21)-Study-related document.docx



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.