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PLASTIC: Prolonged Laparoscopic and Lower Abdominal Surgery Trial – Incidence of Complications

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001344189
Acronym
PLASTIC (Prolonged Laparoscopic/lower Abdominal Surgery Trial: Incidence of Complications)
Enrollment
267
Registered
2019-10-01
Start date
2014-03-27
Completion date
2015-07-30
Last updated
2019-10-07

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

Conditions

None listed

Brief summary

Respiratory complications are reportedly very low (<2%) following open incision lower abdominal surgery and simple laparoscopic upper gastrointestinal surgery (e.g. lap choles). Due to a high cost to benefit ratio, prophylactic physiotherapy directed respiratory exercises and assisted early ambulation is not provided to these patients over and above standard ward care in a majority of hospitals in Australia or Europe. However as more complex procedures, such as bowel resections are increasingly being performed, the corresponding operation times are extending well past 3 hours. This may independently increase the risk of a respiratory complication. However, reports on respiratory complications in prolonged (>3r) laparoscopic and open lower abdominal is lacking. This trial aims to measure rates of respiratory complications in this population in the context of standard hospital ward care. Risk prediction modelling of those patients at highest risk will ensure that future prophylactic delivery of respiratory exercises and Physiotherapy is targeted to those patients that most require them.

Interventions

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

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.

Sponsors

Launceston General Hospital
Lead SponsorHospital

Eligibility

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

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.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026