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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
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Scientific title
Effect of Intraoperative Humidified CO2 Insufflation in Open Laparotomy Colorectal Surgery Patients: a Randomized Controlled Trial
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Secondary ID [1]
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HREC/12/CRGH/196
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peritoneal Inflammation
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Peritoneum; Injury
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Inflammatory cytokine level in the peritoneal biopsy samples
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Assessment method [1]
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Peritoneal samples will be taken when the peritoneal cavity is being opened (at beginning of operation), and also when the peritoneal cavity is being closed (at end of the operation). The change in the level of inflammatory cytokines in between these two time points will be measured
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Timepoint [1]
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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)
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Primary outcome [2]
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Intraoperative temperature at 30 minutes from start of operation
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Assessment method [2]
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Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
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Timepoint [2]
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30 minutes from start of operation
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Primary outcome [3]
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Intraoperative temperature at 60 minutes from start of operation
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Assessment method [3]
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Temperature readings during the operation will be taken. Both core body temperature (esophageal) and intraperitoneal temperature will be measured.
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Timepoint [3]
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60 minutes from start of operation
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Secondary outcome [1]
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Postoperative Analgesia requirement for pain
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Assessment method [1]
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Postoperative pain as measured by MEDD (Morphine Equivalent Daily Dose)
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Timepoint [1]
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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
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Secondary outcome [2]
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Length of in-patient hospital stay
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Assessment method [2]
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number of days patient stayed postoperatively in hospital
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Timepoint [2]
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duration of hospital stay, an expected average of 1 week
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Secondary outcome [3]
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Anastomotic leaks
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Assessment method [3]
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The occurrence of anastomotic leak in the 6 months after the surgery
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Timepoint [3]
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6 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2016
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Sydney
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Recruitment postcode(s) [1]
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2138 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Concord Repatriation General Hospital
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02975947
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02975947
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