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Trial registered on ANZCTR


Registration number
ACTRN12610000423011
Ethics application status
Not yet submitted
Date submitted
20/05/2010
Date registered
26/05/2010
Date last updated
26/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Peritoneal Lavage Influence the Rate of Complications in Paediatric Laparoscopic Appendicectomy? A Prospective Randomised Clinical Trial.
Scientific title
Does Peritoneal Lavage Influence the Rate of Complications in Paediatric Laparoscopic Appendicectomy? A Prospective Randomised Clinical Trial.
Secondary ID [1] 251820 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perforated appendicitis in children 257418 0
Condition category
Condition code
Surgery 257567 257567 0 0
Surgical techniques
Oral and Gastrointestinal 257612 257612 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
Patients with perforated appendicitis will be ascribed to one of two groups. One group will recieve peritoneal lavage with 0.9% saline followed by suction and the second group will recieve suction only. Lavage is performed during the surgery with warm saline generally between 1-2 litres until the performing surgeon jucges that the saline being suctioned out of the abdomen is clear. It take somewhere between 3- 10 mintues.
Intervention code [1] 256522 0
Treatment: Surgery
Comparator / control treatment
The no lavage group is the control. That is , this group has a routine appendectomy and no peritoneal lavage. The duration of no lavage is 0 mintues.
Control group
Active

Outcomes
Primary outcome [1] 258484 0
Length of hospital stay in days, including any days of re-admission. All data will be collected prospectivly when the patient is an inpatient by the principle investigator. The principle investigator will call the parents at 6 weeks post operatively to ensure that no one is lost to follow up.
Timepoint [1] 258484 0
6 week follow up
Secondary outcome [1] 264273 0
Intra-abdominal abscess. Assessed by re-presentation with abdominal pain, fever, tenderness, raised inflammatory markers and ultrasound evidence of a collection.
Timepoint [1] 264273 0
6 weeks post surgery

Eligibility
Key inclusion criteria
Children with perforated appendicitis and/or widespread pus in the peritoneal cavitiy
Minimum age
1 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non perforated appendicitis with little or no peritoneal pus
Conversion to open appendectomy

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)
Pre-operatively all patients who are being taken to theatre for laparoscopic appendicectomy will be consented with regard to the study. In theatre the surgeon makes a subjective decision as to whether the appendix is perforated or there is widespread pus in the abdomen.At this point enrolment takes place. Routine appendicectomy is performed and then the patients will be randomised into 2 intervention groups. One group will receive peritoneal lavage and suction, and the second group will receive suction alone. The lavage group will receive 0.9% saline lavage until the surgeon judges that the lavage fluid is clear. Randomization will be provided in association with the department of human research and biostatistics at Monash University using a random 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. ie. theatre nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Excel program randon sequence generator with equal numbers to both groups.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257007 0
Self funded/Unfunded
Name [1] 257007 0
Country [1] 257007 0
Primary sponsor type
Individual
Name
Charles Keys
Address
Department of Paediatric Surgery
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Country
Australia
Secondary sponsor category [1] 256269 0
Individual
Name [1] 256269 0
Professor Wei Cheng
Address [1] 256269 0
Professor of Paediatric Surgery
Department of Paediatric Surgery
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Country [1] 256269 0
Australia
Other collaborator category [1] 1281 0
Individual
Name [1] 1281 0
Ass Professor Damien Jollie
Address [1] 1281 0
Associate Professor and Senior Biostatistician
School of Public Health & Preventive Medicine
Level 6, The Alfred Centre
99 Commercial Road
Melbourne 3004
Vic
Country [1] 1281 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259028 0
MOnash Medical Centre Resarch Committee
Ethics committee address [1] 259028 0
Research Directorate
Level 4, Main Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 259028 0
Australia
Date submitted for ethics approval [1] 259028 0
20/05/2010
Approval date [1] 259028 0
Ethics approval number [1] 259028 0

Summary
Brief summary
Appendicitis is the most common abdominal pathology in children. Laparoscopic appendicectomy is the standard treatment in most developed countries. Infection remains the most common post operative complication; with reported rates between 2.5–36% Currently at Monash Medical Centre we perform approximately 330 laparoscopic appendicectomies per 12 month period. Of these approximately one third will be perforated appendicitis with significant peritoneal pus. Our overall infection rate is 5%. The abscess formation rate for the perforated appendicitis group is higher, 11.3%. Compared to the best reported results in the literature, there is room for improvement.

Peritoneal lavage is an intraoperative manoeuvre performed whereby following removal of contamination the peritoneal cavity is lavaged with saline and then suction applied to remove the saline solution. At appendicectomy not all surgeons will perform peritoneal lavage.
Peritoneal irrigation has been advocated as a method to reduce post operative complications. The evidence for peritoneal lavage is largely historical and based on adult practice . It is proposed that lavage reduces intraperitoneal bacterial load, and furthermore that laparoscopy facilitates improved peritoneal lavage in peritonitis.
However, the evidence is divided with some indicating that it may in fact increase the risk of post operative infections. Advocates of this argument proposed that lavage may spread contamination throughout the peritoneal cavity with an increased risk of abscess formation. Studies assessing lavage with antibiotic solutions have shown no difference in outcomes
Currently throughout the world there is no consensus and both techniques are commonplace and accepted modes of practice. Within our department of Paediatric Surgery in Monash Medical Centre there are surgeons who advocate generous lavage and other surgeons who advocate no lavage. Currently our patients will receive lavage or not depending on which consultant is in charge of their care.
To date there have been no prospective randomized clinical studies in children assessing the difference in outcome in laparoscopic appendicectomy following peritoneal lavage or no peritoneal lavage.
Therefore, the aim of this study is to assess whether intraoperative peritoneal lavage in laparoscopic appendicectomy in children reduces post operative complications, with the eventual goal of minimizing post-operative infection rate. Our proposal is to carry out a prospective randomised clinical trial.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31195 0
Address 31195 0
Country 31195 0
Phone 31195 0
Fax 31195 0
Email 31195 0
Contact person for public queries
Name 14442 0
Charles Keys
Address 14442 0
Department of Paediatric Surgery
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Country 14442 0
Australia
Phone 14442 0
+61 3 95946666
Fax 14442 0
Email 14442 0
[email protected]
Contact person for scientific queries
Name 5370 0
Charles Keys
Address 5370 0
Department of Paediatric Surgery
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168
Country 5370 0
Australia
Phone 5370 0
+61 3 95946666
Fax 5370 0
Email 5370 0
[email protected]

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
EmbaseDoes peritoneal lavage influence the rate of complications following pediatric Laparoscopic Appendicectomy in Children with Complicated Appendicitis? A Prospective Randomized Clinical Trial.2019https://dx.doi.org/10.1016/j.jpedsurg.2019.08.039
N.B. These documents automatically identified may not have been verified by the study sponsor.