Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001344189
Ethics application status
Approved
Date submitted
2/09/2019
Date registered
1/10/2019
Date last updated
1/10/2019
Date data sharing statement initially provided
1/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
PLASTIC: Prolonged Laparoscopic and Lower Abdominal Surgery Trial – Incidence of Complications
Scientific title
Determining the rate of post operative pulmonary complications (PPC), other complications and length of hospital stay in the prolonged laparoscopic, open lower abdominal surgery (LAS) and open hernia repair patient populations.
Secondary ID [1] 299236 0
Nil
Universal Trial Number (UTN)
Trial acronym
PLASTIC (Prolonged Laparoscopic/lower Abdominal Surgery Trial: Incidence of Complications)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Operative Pulmonary Complications 292240 0
Prolonged postoperative paralytic ileus 314221 0
Condition category
Condition code
Surgery 292576 292576 0 0
Other surgery
Respiratory 292577 292577 0 0
Other respiratory disorders / diseases
Anaesthesiology 292578 292578 0 0
Other anaesthesiology
Oral and Gastrointestinal 312584 312584 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients having elective open hernia repairs, prolonged (>180mins) laparoscopic upper abdominal surgery or prolonged (>180mins) lower abdominal abdominal surgery at two Tasmanian hospitals will be be assessed prospectively and daily for the first 14 postoperative days or up to day of discharge, whichever occurs first. Patients will be screened for a postoperative pulmonary complication and prolonged postoperative paralytic ileus using standardized diagnostic screening tools.
A postoperative pulmonary complication will be assessed using the Melbourne Group Score Version 3. A positive diagnosis is determined when any four or more of the following criteria; abnormal auscultation, purulent sputum, oxygen desaturation <90% on room air, temperature >38°C, chest imaging of collapse/consolidation, white cell count >11, positive sputum culture, or physician diagnosis or prescription of antibiotics specific for a respiratory infection, are present in a calendar day. A prolonged paralytic ileus was detected when two or more of the following criteria; nausea or vomiting, unable to tolerate oral diet, absence of flatus, abdominal distension, radiological report of gastrointestinal obstruction or ileus, or doctor diagnosis of ileus, occurred in a calendar day on or after the 4th postoperative day.
Intervention code [1] 315430 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321237 0
Postoperative pulmonary complication measured using the Melbourne Group Score where the concurrent present of four or more of the following criteria within a calendar day are considered a positive diagnosis.
a) New abnormal breath sounds on auscultation different from preoperative assessment
b) Production of yellow or green sputum different from preoperative assessment
c) Pulse oximetry oxygen saturation <90% on room air on more than one consecutive postoperative day
d) Maximum oral temperature >38C on more than one consecutive postoperative day
e) Chest imaging report of collapse/consolidation
f) An unexplained white cell count >11 or prescription of an antibiotic specific for a respiratory infection
g) Presence of infection on sputum culture
h) Physician diagnosis of pneumonia, respiratory tract infection, or severe atelectasis
Timepoint [1] 321237 0
Daily for the first 14 postoperative days or day of discharge whichever occurs first
Primary outcome [2] 321238 0
Postoperative paralytic ileus. A positive diagnosis is identified when 2 or more of the following criteria occur concurrently within the same calendar day, on or after the 4th postoperative day. Data is taken from documentation in the medical record.
a) Nausea or vomiting
b) Unable to tolerate an oral diet over previous 24h
c) Absence of flatus over the previous 24h
d) Abdominal distension
e) Radiologic confirmation of ileus or gastrointestinal obstruction
Timepoint [2] 321238 0
Daily for the first 14 postoperative days or day of discharge whichever occurs first
Secondary outcome [1] 374420 0
Time to readiness to discharge. Short-term acute postoperative recovery will be measured using 8 standardized criteria. When all criteria are met concurrently within a calendar day, this is considered 'ready for discharge':
a) Patient is able to tolerate at least one solid meal without nausea, vomiting, bloating, or worsening abdominal pain. Patient drinking liquids actively and not requiring IV fluids for hydration.
b) Patient has passed flatus
c) Patient is able to be active out of bed without significant pain while taking oral analgesics
d) Patient able to sit up, walk, and perform activities of daily living
e) Normal temperature
f) Normal pulse, blood pressure, respiratory rate
g) Serum haemoglobin is stable and acceptable (females >120, males>140)
h) Patient able to empty bladder without difficulty.
Data will be taken from all available multi-disciplinary integrated electronic and written progress notes, observation and medication charts, and pathology results.
Timepoint [1] 374420 0
Daily for the first 14 postoperative days or day of discharge whichever occurs first.
Secondary outcome [2] 374421 0
Hospital length of stay, defined as the days between day of surgery and day of discharge inclusive.
Data will be taken from central hospital databases recording the episode of care activity.
Timepoint [2] 374421 0
Measured daily until day of discharge
Secondary outcome [3] 374422 0
Discharge destination (home, nursing home, rehabilitation, other hospital)
Data will be assessed using documentation from within the medical record and verified using central hospital databases recording the episode of care activity.
Timepoint [3] 374422 0
On discharge from hospital
Secondary outcome [4] 374423 0
Inhospital mortality
Timepoint [4] 374423 0
During hospital stay
Secondary outcome [5] 374424 0
12-month mortality
Data will be collected from central government hospital databases which have automatic data-linkage with the National Death Registry.
Timepoint [5] 374424 0
12 months from day of surgery
Secondary outcome [6] 374425 0
Physiotherapy provision in hospital determined through daily review of the medical records.
Timepoint [6] 374425 0
Daily for first 14 postoperative days or day of discharge whichever occurs first
Secondary outcome [7] 374705 0
Reason for referral for physiotherapy.
Data taken from daily review of medical record.
Timepoint [7] 374705 0
Daily for first postoperative days or day of discharge whichever occurs first.
Secondary outcome [8] 374706 0
Mode of physiotherapy service if provided.
Data taken from daily review of medical record.
Timepoint [8] 374706 0
Daily for first postoperative days or day of discharge whichever occurs first.

Eligibility
Key inclusion criteria
All adults (>18yrs old) admitted for a minimum overnight stay who have had any of the following:
- Any open hernia repairs (paraumbilical, umbilical, incisional, ventral)
- Advanced laparoscopic surgery (eg bowel resections/liver resections, nephrectomies)
- Standard laparoscopic abdominal surgery (eg lap choles, lap hiatus hernia repairs) more than 3hrs in duration
- Open lower abdominal surgery (e.g. radical prostatectomies, ultra low anterior resections, total abdominal hysterectomies etc) more than 3hrs in duration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
To determine the incidence of postoperative pulmonary complications in this surgical group with an estimated prevalence of 1-15% will require a minimum sample of 70 to 270 dependent on the sub-type baseline prevalence rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/03/2014
Date of last participant enrolment
Anticipated
Actual
30/07/2015
Date of last data collection
Anticipated
Actual
30/07/2016
Sample size
Target
270
Accrual to date
Final
267
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 14677 0
Launceston General Hospital - Launceston
Recruitment hospital [2] 14678 0
North West Regional Hospital - Burnie
Recruitment postcode(s) [1] 27706 0
7250 - Launceston
Recruitment postcode(s) [2] 27707 0
7320 - Burnie

Funding & Sponsors
Funding source category [1] 303696 0
Charities/Societies/Foundations
Name [1] 303696 0
Clifford Craig Foundation
Country [1] 303696 0
Australia
Funding source category [2] 303697 0
University
Name [2] 303697 0
University of Tasmania
Country [2] 303697 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
PO BOX 1963
Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 303802 0
None
Name [1] 303802 0
Address [1] 303802 0
Country [1] 303802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304220 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 304220 0
Ethics committee country [1] 304220 0
Australia
Date submitted for ethics approval [1] 304220 0
15/03/2014
Approval date [1] 304220 0
26/03/2014
Ethics approval number [1] 304220 0
H0013754

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40662 0
Ms Ianthe Boden
Address 40662 0
Clifford Craig Foundation
PO BOX 1963
Launceston TAS 7250
Country 40662 0
Australia
Phone 40662 0
+61 03 6777 6777
Fax 40662 0
Email 40662 0
[email protected]
Contact person for public queries
Name 40663 0
Ianthe Boden
Address 40663 0
Clifford Craig Foundation
PO BOX 1963
Launceston TAS 7250
Country 40663 0
Australia
Phone 40663 0
+61 03 6777 6777
Fax 40663 0
Email 40663 0
[email protected]
Contact person for scientific queries
Name 40664 0
Ianthe Boden
Address 40664 0
Clifford Craig Foundation
PO BOX 1963
Launceston TAS 7250
Country 40664 0
Australia
Phone 40664 0
+61 03 6777 6777
Fax 40664 0
Email 40664 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Did not include this within original ethics application in 2014


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
No additional documents have been identified.