Probiotic use and post-operative recovery following appendicectomy in children.

Not Applicable

Recruiting

• Conditions: Appendicitis; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620001343998
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-14
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

1.Patients aged 4-13 years
2.No associated co-morbidities (ASA 1)
3.Undergoing laparoscopic appendicectomy for simple (non-perforated) or complicated (perforated) appendicitis

Exclusion Criteria

1.Any associated co-morbidities (ASA 2 and above as confirmed independently by the anaesthetist and surgeon prior to appendicectomy; if disagreement a third doctor, anaesthetist or surgeon, will be consulted)
2.Prior antibiotic use within the previous 3 months
3.Previous history of significant gastrointestinal conditions (e.g. IBD, etc.) or metabolic conditions (e.g. diabetes mellitus) even if well controlled
4.Immunocompromised patients or patients taking immunosuppressant drugs
5.Overseas travel within the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence (number of episodes per day) of antibiotic associated diarrhoea (AAD) after post-appendicectomy intravenous antibiotic administration.<br>This outcome will be assessed from data-linkage to medical records.[Four weeks after taking the first probiotic/placebo. The first day will be when the patient has their first bowel motion after appendicectomy.];Duration (number of days) of antibiotic associated diarrhoea (AAD) after post-appendicectomy intravenous antibiotic administration.<br>This outcome will be assessed from data-linkage to medical records.[Four weeks after taking the first probiotic/placebo. The first day will be when the patient has their first bowel motion after appendicectomy]

Secondary Outcome Measures

Name	Time	Method
Incidence of post-operative intra-abdominal abscess formation obtained from the hospital records.[Within fourteen days after the appendicectomy.];Level of stress/anxiety post-surgery using the standardised Emotionality Activity Sociability and Impulsivity (EASI) questionnaire. [Four weeks after taking the first probiotic/placebo. The first day will be when the patient has their first bowel motion after appendicectomy.];Time to return to school; participant-reported outcome.<br><br>[From time of appendicectomy.];Microbial diversity measured as number of viable species in stools sample.[Two and four weeks after taking the first probiotic/placebo. The first day will be when the patient has their first bowel motion after appendicectomy.]