Table 1 World Health Organisation (WHO) Trial Registration Data Set for LIPPSMAck POP trial
Data category | Information |
|---|---|
Primary registry and trial identifying number | Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 |
Date of registration in primary registry | 19/6/2013 |
Secondary identifying numbers | n/a |
Trial protocol version | This is Version 4 of the protocol and was enacted on June 2013 |
Source(s) of monetary or material support | Clifford Craig Medical Research Trust ($60,000 AUD) |
University of Tasmania, virtual Tasmanian Academic Health Precinct ($50,000 AUD) | |
Waitemata District Health Board and Three Harbours Health Foundation ($20,000 NZD) | |
Tasmanian Health Service - Northern Region ($120,000 AUD) | |
Primary sponsor | Tasmanian Health Service - Northern Region |
Secondary sponsor | Waitemata District Health Board |
Contact for public queries | IB, ianthe.boden@ths.tas.gov.au |
Contact for scientific queries | IB, ianthe.boden@ths.tas.gov.au |
Public title | Pre-operative physiotherapy education for the prevention of chest infections following major abdominal surgery |
Scientific title | LIPPSMAck POP trial – Pre-operative physiotherapy education for the prevention of post-operative pulmonary complications following major upper abdominal surgery: a bi-national, multi-centre, randomised, double-blinded placebo controlled trial. |
Countries of recruitment | Australia, New Zealand |
Health condition(s) or problem(s) studied | Pulmonary complications following major upper abdominal surgery |
Intervention(s) | Active comparator: Pre-operative physiotherapy education and training |
Placebo comparator: Education booklet | |
Key inclusion and exclusion criteria | Ages eligible for study: ≥ 18 years |
Sexes eligible for study: both | |
Accepts health volunteers: No | |
Inclusion criteria: All adults awaiting elective upper abdominal surgery involving an open incision above the umbilicus. | |
Exclusion criteria: 1. Any pre-existing condition that would limit ability to participate in the standardised post-operative mobilisation protocol. Defined as any person unable to stand upright and walk for a maximum of 1Â min without a seated rest. 2. Unable to understand verbal instructions in English. 3. Unable to attend a pre-admission assessment and education session with a physiotherapist. 4. Open abdominal hernia repairs. | |
Study type | Type: Investigator initiated, interventional, non-pharmacological, pragmatic, study |
Allocation: Concealed randomisation | |
Intervention model: parallel assignment | |
Masking: patient and assessor blinded | |
Primary purpose: Prevention | |
Phase: Phase III | |
Date of first enrolment | 24/6/2013 |
Target sample size | 441 |
Recruitment status | Recruiting |
Primary outcome(s) | Post-operative pulmonary complications during the first 14 days of the hospital stay |
Key secondary outcomes | Pneumonia, length of hospital stay, hospital costs, day of ambulation >10mins, length of ICU stay, ICU readmission, post-operative adverse events, day to discharge from post-operative physiotherapy services, patient-reported complications, health-related quality of life, and physical capacity at 6Â weeks following discharge from hospital. |