GallstonePhase 4NCT00792389
Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies
A Phase 4 study testing Warm humidified C02 and Cool dry C02 in people with Gallstone, run by Pennine Acute Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone
- What is being tested?
- Warm humidified C02 and Cool dry C02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic cholecystectomy
- 18 years of age or over
Who cannot join
- under 18 years of age
- prisoners
- converted to open operation
- secondary invasive procedure during operation
- unable to give consent for whatever reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?
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.
- Conditions
- Gallstone
- Being tested
- Warm humidified C02, Cool dry C02
- Keywords
- Gallstones, Gallbladder, Cholecystectomy, Gallstone disease
- Medical subject headings
- Gallstones, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm humidified C02Other
Also called Fisher Paykall laparoscopic humidifier
Insufflation of warmed humidified gas during laparoscopic cholecystectomy
Cool dry C02Other
Insufflation of cool dry gas during laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving warmed, humidified gas Receives: Other: Warm humidified C02 |
| 2 | Active comparator | Patients receiving cool, day gas Receives: Other: Cool dry C02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total post operative opiate analgesia - morphine equivalent dose.
Measured: 1 day
Secondary outcomes (1)
Subjective post operative pain as defined on numerical pain scales
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennine Acute Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- David Flook, MBChB, Principal investigator, Pennine Acute Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792389
- Sponsor's protocol ID
- PAT-HWA-001
- Status last verified
- Nov 2008
- First submitted
- 14 Nov 2008
- Last updated
- 17 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?
- ClinicalTrials.gov ID
- NCT00792389
- Acronym / sponsor ID
- PAT-HWA-001
- Conditions
- Gallstone
- Keywords
- Gallstones, Gallbladder, Cholecystectomy, Gallstone disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pennine Acute Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Warm humidified C02Patients receiving warmed, humidified gas |
| 2 | Active comparator | Other: Cool dry C02Patients receiving cool, day gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective laparoscopic cholecystectomy
- 18 years of age or over
Key exclusion criteria (5 listed)
- under 18 years of age
- prisoners
- converted to open operation
- secondary invasive procedure during operation
- unable to give consent for whatever reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm humidified C02Also: Fisher Paykall laparoscopic humidifierInsufflation of warmed humidified gas during laparoscopic cholecystectomy | Other | 1 |
| Cool dry C02Insufflation of cool dry gas during laparoscopic cholecystectomy | Other | 2 |
Primary outcome
Total post operative opiate analgesia - morphine equivalent dose.
Time frame: 1 day
1 secondary outcome
Subjective post operative pain as defined on numerical pain scales
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2008.
Related trials for Gallstone
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Flook, MBChB principal investigator
Pennine Acute Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warm humidified C02 and Cool dry C02 in people with Gallstone, run by Pennine Acute Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie L Trevelyan, MBChB (01616200420 ext. 78985, stephanie.trevelyan@pat.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total post operative opiate analgesia - morphine equivalent dose. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2008.