Humidification in Laparoscopic Colonic Surgery - Full Text View

Purpose

Laparoscopic surgery allows surgeons to remove bowel via small incisions. To allow insertion of a camera and instruments, cold and dry gas is blown into the abdominal cavity. This project investigates the use of warmed, humidified gas in laparoscopic surgery. The hypothesis is that this will result in less damage to internal surfaces, and shorten recovery time. Previous studies have demonstrated positive outcomes in laparoscopic gallbladder operations. We plan to study patients undergoing laparoscopic colon operations, as these operations are longer and the effect of humidification will be magnified. We will enroll 70 patients: 35 will have the operation with cold dry gas, and 35 will have warm, humidified gas. We will measure intraoperative heat loss, postoperative pain, fatigue, nausea and vomiting, and time to return of bowel function.

Condition	Intervention
Peritoneal Inflammation	Procedure: Fisher and Paykel Humidifier Procedure: Standard insufflation

MedlinePlus related topics:

Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Humidification in Laparoscopic Colonic Surgery - A Double Blinded, Randomised Controlled Trial.

Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:

Pain by visual analogue scale [ Time Frame: 2 hours, 4 hours, 8 hours, 12 hours, day 1, day 2, day 3, day 7, day 14, day 30, day 60 ] [ Designated as safety issue: No ]
Fatigue by Identity-Consequence Fatigue Scale [ Time Frame: day 1, day 3, day 7, day 30, day 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intraoperative temperature by oeseophageal probe [ Time Frame: 15min intervals during surgery ] [ Designated as safety issue: No ]
Peritoneal cytokine concentration [ Time Frame: Morning of surgery ] [ Designated as safety issue: No ]
Morphine equivalent analgesia use [ Time Frame: PACU, day of OT, day 1, day 2, day 3 ] [ Designated as safety issue: No ]
Antiemetic use [ Time Frame: PACU, day of OT, day 1, day 2, day 3 ] [ Designated as safety issue: No ]
Return of bowel function - passage of flatus, bm, and eating first meal [ Time Frame: daily ] [ Designated as safety issue: No ]
Any complications [ Time Frame: Postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Humidified and warmed carbon dioxide laparoscopic insufflation.	Procedure: Fisher and Paykel Humidifier Humidification to 98% relative humidity, and warming to 40 degrees C of laparoscopic insufflate. This will be done for the duration of the operation.
2: Placebo Comparator Cold and dry carbon dioxide laparoscopic insufflation.	Procedure: Standard insufflation No humidifer or warmer will be used (device switched off). This will deliver laparoscopic insufflate at 0% humidity and 20 degrees C.

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Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients undergoing colonic resection at all three auckland hospitals.

Exclusion Criteria:

Stoma formation
Conversion to open surgery
Use of steroids
Inability to consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642005

Contacts


Contact: Tarik Sammour, MBChB	+6421317417	tsammour@middlemore.co.nz

Locations


New Zealand
	Auckland City Hospital	Recruiting
	Auckland, New Zealand
	Contact: Tarik Sammour, MBChB +6421317417 tsammour@middlemore.co.nz
	Principal Investigator: Tarik Sammour, MBChB
	Sub-Investigator: Julian Hayes, MBChB, FRACS
	North Shore Hospital	Recruiting
	Auckland, New Zealand
	Contact: Tarik Sammour, MBChB +6421317417 tsammour@middlemore.co.nz
	Principal Investigator: Tarik Sammour, MBChB
	Sub-Investigator: Mike Hulme-Moir, MBChB, FRACS

New Zealand, Otahuhu
	Middlemore Hospital	Recruiting
	Auckland, Otahuhu, New Zealand
	Contact: Tarik Sammour, MBChB +6421317417 tsammour@middlemore.co.nz
	Principal Investigator: Tarik Sammour, MBChB
	Sub-Investigator: Andrew Hill, MBChB, MD, FRACS

Sponsors and Collaborators

University of Auckland, New Zealand

Investigators


Study Chair:	Andrew G Hill, MBChB, MD, FRACS	University of Auckland, New Zealand

More Information

Responsible Party:	Department of Surgery, South Auckland Clinical School, University of Auckland ( Dr Tarik Sammour )
Study ID Numbers:	Laphumid
First Received:	March 17, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00642005
Health Authority:	New Zealand: Health and Disability Ethics Committees

Keywords provided by University of Auckland, New Zealand:

Humidification

Laparoscopy

Colon

Hemicolectomy

Warming

Study placed in the following topic categories:

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	University of Auckland, New Zealand
Information provided by:	University of Auckland, New Zealand
ClinicalTrials.gov Identifier:	NCT00642005