Humidification in Laparoscopic Colonic Surgery - Full Text View

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

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.

The investigators plan to study patients undergoing laparoscopic colon operations, as these operations are longer and the effect of humidification will be magnified. The investigators will enroll 74 patients: 37 will have the operation with cold dry gas, and 37 will have warm, humidified gas. The investigators 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 (MR860) Procedure: Standard insufflation

MedlinePlus related topics: Gas Nausea and Vomiting Surgery

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: preop, 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 ]
Morphine equivalent analgesia use [ Time Frame: PACU, day of OT, day 1, day 2, day 3, total in hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intraoperative temperature by oeseophageal probe [ Time Frame: 15min intervals during surgery ] [ Designated as safety issue: No ]
Plasma and peritoneal cytokine and antioxidant concentration [ Time Frame: Morning of surgery ] [ 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: Up to 3 months postoperatively ] [ Designated as safety issue: Yes ]
Fatigue by Identity-Consequence Fatigue Scale (ICFS) [ Time Frame: preop, day 1, day 2, day 3, day 7, day 30, day 60 ] [ Designated as safety issue: No ]

Estimated Enrollment:	74
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 (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.
2: Placebo Comparator 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.

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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 15 years and over undergoing elective laparoscopic colonic resection at all three auckland hospitals.

Exclusion Criteria:

Acute cases
Stoma formation (preop or intraop decision)
Decision to change to open surgery preoperatively (intraop conversions included as intention to treat)
Rectal lesions defined as 15cm from anal verge on imaging and/or sigmoidoscopy / colonoscopy
Steroid dependence
Inability to consent or answer ICFS questions due to cognitive impairment or language barrier
ASA >= 4

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

No publications provided

Responsible Party:	Department of Surgery, South Auckland Clinical School, University of Auckland ( Dr Tarik Sammour )
Study ID Numbers:	Laphumid
Study First Received:	March 17, 2008
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00642005 History of Changes
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
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009