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Does Peritoneal Lavage Influence the Rate of Complications in Paediatric Laparoscopic Appendicectomy? A Prospective Randomised Clinical Trial.

Does Peritoneal Lavage Influence the Rate of Complications in Paediatric Laparoscopic Appendicectomy? A Prospective Randomised Clinical Trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000423011
Enrollment
100
Registered
2010-05-26
Start date
2010-06-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Charles Keys
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

Children with perforated appendicitis and/or widespread pus in the peritoneal cavitiy

Exclusion criteria

Non perforated appendicitis with little or no peritoneal pus Conversion to open appendectomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026