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Humidification in Laparoscopic Colonic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrew G Hill, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00642005
First received: March 17, 2008
Last updated: March 10, 2014
Last verified: March 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Humidification in Laparoscopic Colonic Surgery - A Double Blinded, Randomised Controlled Trial.

Further study details as provided by Andrew G Hill, 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 ]
  • Morphine equivalent analgesia use [ Time Frame: PACU, day of OT, day 1, day 2, day 3, total in hospital ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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.


Enrollment: 82
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 15 cm from anal verge on imaging and/or sigmoidoscopy / colonoscopy
  • Steroid dependence
  • Inability to consent or answer SRS questions due to cognitive impairment or language barrier
  • ASA >= 4
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
New Zealand
Middlemore Hospital
Auckland, Otahuhu, New Zealand
Auckland City Hospital
Auckland, New Zealand
North Shore Hospital
Auckland, New Zealand
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
Study Chair: Andrew G Hill, MBChB, MD, FRACS University of Auckland, New Zealand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew G Hill, Professor of Surgery, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT00642005     History of Changes
Other Study ID Numbers: Laphumid
Study First Received: March 17, 2008
Last Updated: March 10, 2014

Keywords provided by Andrew G Hill, University of Auckland, New Zealand:
Humidification
Laparoscopy
Colon
Hemicolectomy
Warming

Additional relevant MeSH terms:
Inflammation
Peritonitis
Pathologic Processes
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 19, 2017