ANZCTR - Registration

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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]

N/A

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perforated appendicitis in children

Condition category

Condition code

Surgery

Surgical techniques

Oral and Gastrointestinal

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]

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]

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]

6 week follow up

Secondary outcome [1]

Intra-abdominal abscess. Assessed by re-presentation with abdominal pain, fever, tenderness, raised inflammatory markers and ultrasound evidence of a collection.

Timepoint [1]

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?

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Individual

Name [1]

Professor Wei Cheng

Address [1]

Professor of Paediatric Surgery
Department of Paediatric Surgery
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Ass Professor Damien Jollie

Address [1]

Associate Professor and Senior Biostatistician
School of Public Health & Preventive Medicine
Level 6, The Alfred Centre
99 Commercial Road
Melbourne 3004
Vic

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

MOnash Medical Centre Resarch Committee

Ethics committee address [1]

Research Directorate
Level 4, Main Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/05/2010

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Charles Keys

Address

Department of Paediatric Surgery
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168

Country

Australia

Phone

+61 3 95946666

Fax

charleskeys@doctors.org.uk

Contact person for scientific queries

Name

Charles Keys

Address

Department of Paediatric Surgery
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton
Vic 3168

Country

Australia

Phone

+61 3 95946666

Fax

charleskeys@doctors.org.uk

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

Source	Title	Year of Publication	DOI
Embase	Does peritoneal lavage influence the rate of complications following pediatric Laparoscopic Appendicectomy in Children with Complicated Appendicitis? A Prospective Randomized Clinical Trial.	2019	https://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.

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Documents added manually

Documents added automatically