NCT00792389

Brief Summary

Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

November 17, 2008

Status Verified

November 1, 2008

Enrollment Period

1 year

First QC Date

November 14, 2008

Last Update Submit

November 14, 2008

Conditions

Gallstone

Keywords

GallstonesGallbladderCholecystectomyGallstone disease

Outcome Measures

Primary Outcomes (1)

  • Total post operative opiate analgesia - morphine equivalent dose.

    1 day

Secondary Outcomes (1)

  • Subjective post operative pain as defined on numerical pain scales

    1 day

Study Arms (2)

1

EXPERIMENTAL

Patients receiving warmed, humidified gas

Other: Warm humidified C02

2

ACTIVE COMPARATOR

Patients receiving cool, day gas

Other: Cool dry C02

Interventions

Warm humidified C02OTHER

Insufflation of warmed humidified gas during laparoscopic cholecystectomy

Also known as: Fisher Paykall laparoscopic humidifier
1
Cool dry C02OTHER

Insufflation of cool dry gas during laparoscopic cholecystectomy

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic cholecystectomy
  • years of age or over

You may not qualify if:

  • under 18 years of age
  • prisoners
  • converted to open operation
  • secondary invasive procedure during operation
  • unable to give consent for whatever reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Oldham Hospital

Oldham, Lancashire, OL1 2JH, United Kingdom

Location

MeSH Terms

Conditions

GallstonesCholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • David Flook, MBChB

    Pennine Acute Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie L Trevelyan, MBChB

CONTACT

01616200420stephanie.trevelyan@pat.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

November 17, 2008

Record last verified: 2008-11

Locations

GB(1)