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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02975947




Registration number
NCT02975947
Ethics application status
Date submitted
2/11/2016
Date registered
29/11/2016
Date last updated
29/11/2016

Titles & IDs
Public title
Effect of Warmed Humidified CO2 on Peritoneum During Laparotomy
Scientific title
Effect of Intraoperative Humidified CO2 Insufflation in Open Laparotomy Colorectal Surgery Patients: a Randomized Controlled Trial
Secondary ID [1] 0 0
HREC/12/CRGH/196
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Inflammation 0 0
Peritoneum; Injury 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand)
Treatment: Devices - Standard heating

Active Comparator: Control Group - Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head.

Experimental: Study Group - The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide delivered into the open peritoneal cavity.


Treatment: Devices: Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand)
The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide into the open peritoneal cavity using the Fisher & Paykel's HUMIGARD system (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand). This will create a local atmosphere of 100% carbon dioxide (warmed, humidified) in the open peritoneal cavity.

Treatment: Devices: Standard heating
Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Inflammatory cytokine level in the peritoneal biopsy samples
Timepoint [1] 0 0
At the moment of time when: (1) peritoneal cavity is being opened, (2) when peritoneal cavity is being closed (expected average of 2 hours after peritoneal cavity is first opened)
Primary outcome [2] 0 0
Intraoperative temperature at 30 minutes from start of operation
Timepoint [2] 0 0
30 minutes from start of operation
Primary outcome [3] 0 0
Intraoperative temperature at 60 minutes from start of operation
Timepoint [3] 0 0
60 minutes from start of operation
Secondary outcome [1] 0 0
Postoperative Analgesia requirement for pain
Timepoint [1] 0 0
Time from when the patient is moved out of operating theater to when the patient is no longer an inpatient in the hospital ward (discharged), with an expected average of 1 week
Secondary outcome [2] 0 0
Length of in-patient hospital stay
Timepoint [2] 0 0
duration of hospital stay, an expected average of 1 week
Secondary outcome [3] 0 0
Anastomotic leaks
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
- Adults above age 18.

- Elective patients.

- Pathologies: colorectal carcinoma, polyposis syndromes, diverticular diseases,
prolapses, and patients with inflammatory bowel disease undergoing elective resection.

- For colorectal carcinoma, all patients whether they are having curative or palliative
surgery will be included.

- Patients undergoing open elective colectomy, with or without stoma formation/ bowel
anastomosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients undergoing acute surgery (emergency surgery).

- Patients undergoing Laparoscopic colectomy (multiport, single incision and also hand
assisted) as all these patients receive heated humidified CO2.

- For COPD patients, the exclusion criteria would be patients: (1) On home oxygen, (2)
Type 2 respiratory failure (CO2 retainers) (3) FEV1<1L, or FEV1/FVC <50% of predicted

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2138 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Concord Repatriation General Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The operating theatre is deliberately made to be cold and dry to prevent bacteria from
growing. The problem with this is that during open abdominal surgery, the intestine and the
overlying peritoneum is exposed to cold dry air. Surgeons try to stop the bowel/peritoneum
from drying by applying warmed saline packs periodically to the bowel. However, this is not
always possible. Sometimes, the surgeon has to perform an important component of the
procedure (attach bowel/blood vessels together etc) and the bowel/peritoneum visibly dries.
When bowel/peritoneum dries damage occurs, inducing inflammation. Inflamed bowel/peritoneum
causes the bowel to stick together and form adhesions. Bowel adhesions can cause bowel
obstruction. This vicious cycle is repeated when the patient undergoes repetitive open
abdominal operations.

This study aimed to be the first human study to:

1. Demonstrate that peritoneal inflammation occurs during open abdominal surgery and also
to demonstrate that pro-inflammatory cells (polymorphs, macrophages) are activated
during the progress of the operation. This study aims to show that mRNA(using Q-PCR) is
increased for pro-inflammatory cytokines. This study also aim to show that
proinflammatory cytokines (Interleukin(IL)-1,2,6,9,10, and TNF by ELISA/confirmed using
Western Blotting) are elevated during the course of the operation.

2. Demonstrate that the mechanism of bowel/peritoneal inflammation is causally related to
the bowel/peritoneum drying (dessication).

This study will attempt to prove this by using humidified, warmed carbon dioxide gas which
will warm and moisten the peritoneum/bowel. It is proposed that this will arrest the
peritoneal injury and the inflammation. The investigators will attain peritoneal samples
during open colorectal operations. The investigators will obtain samples at the beginning and
end of the operation. This study design is a randomized controlled trial, where half the
patients will receive humidified, warmed carbon dioxide gas during surgery, and the other
half will get standard open surgery without carbon dioxide. 40 patients will be recruited in
this study. Half (20) will get CO2, and other half (20) will get standard open surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02975947
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries