Efficacy of warm humidified insufflation for reducing post-operative ileus.

Efficacy of warm humidified insufflation for reducing post-operative ileus in women undergoing open surgery for presumed advanced ovarian, tubal or peritoneal malignancy: A randomised single-blind controlled trial.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001419257

Enrollment

226

Registered

2018-08-24

Start date

2018-09-01

Completion date

2020-12-31

Last updated

2021-06-21

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

Conditions

None listed

Brief summary

It is common after surgery to experience a delay in return to normal bowel function which may cause abdominal discomfort and delayed discharge from hospital. The purpose of this study is to investigate if the application of warm humidified carbon dioxide gas in your surgical site during your surgery helps to improve return to bowel function after surgery.

Interventions

Fisher and Paykel HumiGard Surgical Humidification system. The HumiGard system allows insufflation of warm humidified CO2 into the open wound cavity at a flow rate of 10L/min. The conditioned gas is delivered via a PVC tube placed on the edge of the surgical wound. The gas fills the wound cavity for the duration of the surgery. The output temperature is ~37 degrees and relative humidity ~90%. The intervention will be set up by the research nurse and placed in the wound by the operating surgeon.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Age 18 or older Consented for Open Debulking surgery for presumed advanced ovarian, tubal or peritoneal malignancy. Primary, Interval (after initial chemotherapy), or recurrent setting Able to give informed consent and understand risks and benefits of the study

Exclusion criteria

Active inflammatory bowel disease Moderate to severe renal impairment (eGFR<50mL/min/1.73m2) Severe hepatic impairment (Child-Pugh C) Pregnancy Pre-existing gut motility disorder including endocrine, metabolic or neurological cause Pre-operative malnutrition requiring parenteral nutrition Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium

Outcome results