NCT00642005

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

March 17, 2008

Last Update Submit

March 10, 2014

Conditions

Peritoneal Inflammation

Keywords

HumidificationLaparoscopyColonHemicolectomyWarming

Outcome Measures

Primary Outcomes (2)

  • Pain by visual analogue scale

    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

    PACU, day of OT, day 1, day 2, day 3, total in hospital

Secondary Outcomes (6)

  • Intraoperative temperature by esophageal probe

    15 min intervals during surgery

  • Plasma and peritoneal cytokine concentration

    Morning of surgery

  • Antiemetic use

    PACU, day of OT, day 1, day 2, day 3

  • Return of bowel function - passage of flatus, bm, and eating first meal

    daily

  • Any complications

    Up to 3 months postoperatively

  • +1 more secondary outcomes

Other Outcomes (2)

  • Small bowel obstruction

    5 year followup

  • Survival

    5 year followup

Study Arms (2)

1

EXPERIMENTAL

Humidified and warmed carbon dioxide laparoscopic insufflation.

Procedure: Fisher and Paykel Humidifier (MR860)

2

PLACEBO COMPARATOR

Cold and dry carbon dioxide laparoscopic insufflation.

Procedure: Standard insufflation

Interventions

Fisher and Paykel Humidifier (MR860)PROCEDURE

Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation.

1
Standard insufflationPROCEDURE

No humidifier or warmer will be used (device switched off). This will deliver laparoscopic insufflate at 0% humidity and 20 degrees C.

2

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients 15 years and over undergoing elective laparoscopic colonic resection at all three auckland hospitals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Middlemore Hospital

Auckland, Otahuhu, New Zealand

Location

Auckland City Hospital

Auckland, New Zealand

Location

North Shore Hospital

Auckland, New Zealand

Location

Related Publications (1)

  • Sammour T, Hill AG. Five year follow-up of a randomized controlled trial on warming and humidification of insufflation gas in laparoscopic colonic surgery--impact on small bowel obstruction and oncologic outcomes. Int Surg. 2015 Apr;100(4):608-16. doi: 10.9738/INTSURG-D-14-00210.1.

    PMID: 25875541DERIVED

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Study Officials

  • Andrew G Hill, MBChB, MD, FRACS

    University of Auckland, New Zealand

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

NZ(3)