Humidification in Laparoscopic Colonic Surgery
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|ClinicalTrials.gov Identifier: NCT00642005|
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Inflammation||Procedure: Fisher and Paykel Humidifier (MR860) Procedure: Standard insufflation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Humidification in Laparoscopic Colonic Surgery - A Double Blinded, Randomised Controlled Trial.|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||August 2009|
Humidified and warmed carbon dioxide laparoscopic insufflation.
Procedure: Fisher and Paykel Humidifier (MR860)
Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation.
Placebo Comparator: 2
Cold and dry carbon dioxide laparoscopic insufflation.
Procedure: Standard insufflation
No humidifier or warmer will be used (device switched off). This will deliver laparoscopic insufflate at 0% humidity and 20 degrees C.
- Pain by visual analogue scale [ Time Frame: preop, 2 hours, 4 hours, 8 hours, 12 hours, day 1, day 2, day 3, day 7, day 14, day 30, day 60 ]
- Morphine equivalent analgesia use [ Time Frame: PACU, day of OT, day 1, day 2, day 3, total in hospital ]
- Intraoperative temperature by esophageal probe [ Time Frame: 15 min intervals during surgery ]
- Plasma and peritoneal cytokine concentration [ Time Frame: Morning of surgery ]
- Antiemetic use [ Time Frame: PACU, day of OT, day 1, day 2, day 3 ]
- Return of bowel function - passage of flatus, bm, and eating first meal [ Time Frame: daily ]
- Any complications [ Time Frame: Up to 3 months postoperatively ]
- Surgical recovery by SRS [ Time Frame: preop, day 1, day 2, day 3, day 7, day 30, day 60 ]
- Small bowel obstruction [ Time Frame: 5 year followup ]Admission to hospital within 5 years for small bowel obstruction, operative management or non-operative.
- Survival [ Time Frame: 5 year followup ]Overall survival and disease free survival at 5 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642005
|Auckland, Otahuhu, New Zealand|
|Auckland City Hospital|
|Auckland, New Zealand|
|North Shore Hospital|
|Auckland, New Zealand|
|Study Chair:||Andrew G Hill, MBChB, MD, FRACS||University of Auckland, New Zealand|