Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic SurgeryNCT02319902
Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy
A study testing Standard cold carbon dioxide gas and Heated humidified carbon dioxide gas in people with Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery, run by Fevzi Shakir at 1 site in United Kingdom.
Trial summary
To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery
- What is being tested?
- Standard cold carbon dioxide gas and Heated humidified carbon dioxide gas
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.
- Capacity to consent
Who cannot join
- Patients unable to speak English
- Patients unable to give consent
Trial locations and contacts
1 site in 1 country.
Fevzi Shakir, MBBS BSc MRCOG contact
Andrew Kent, TD MD FRCOG contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey County Hospital NHS Trust
Guildford, Surrey, GU2 7XX
Fevzi Shakir, MBBS BSc MRCOG, fevzi@doctors.org.uk
Andrew Kent, TD MD FRCOG, kenta@doctors.org.uk
About this study
Official title: The Effects of Using Heated Humidified Carbon Dioxide Gas on Post Operative Pain Scores, Nausea and Analgesic Requirements in Patients Undergoing Gynaecological Laparoscopy: a Randomised Controlled Trial.
To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.
- Being tested
- Standard cold carbon dioxide gas, Heated humidified carbon dioxide gas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cold carbon dioxide gasDevice
Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.
Heated humidified carbon dioxide gasDevice
Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard cold carbon dioxide gas | Placebo comparator | Standard cold carbon dioxide gas Receives: Device: Standard cold carbon dioxide gas |
| Heated humidified carbon dioxide gas | Active comparator | Heated humidified carbon dioxide gas Receives: Device: Heated humidified carbon dioxide gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder tip pain
Shoulder tip pain recorded as a visual analogue scale from 1-10, 8 hours post surgery compared to baseline
Measured: 8 hours
Secondary outcomes (2)
General abdominal pain, nausea, vomiting and analgesia requirements
General abdominal pain, nausea, vomiting and analgesia requirements 8 hours post surgery compared to baseline
Measured: 8 hours
Shoulder tip pain, general abdominal pain, nausea, vomiting.
Shoulder tip pain, general abdominal pain, nausea, vomiting over a 7 day period compared to baseline
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fevzi Shakir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fevzi Shakir, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319902
- Sponsor's protocol ID
- 14SURN0015
- Status last verified
- Dec 2014
- First submitted
- 14 Dec 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Heated Humidified Carbon Dioxide Gas on Post Operative Pain Scores, Nausea and Analgesic Requirements in Patients Undergoing Gynaecological Laparoscopy: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02319902
- Acronym / sponsor ID
- 14SURN0015
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Fevzi ShakirUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Dec 2014 (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.
To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cold carbon dioxide gas | Placebo comparator | Device: Standard cold carbon dioxide gasStandard cold carbon dioxide gas |
| Heated humidified carbon dioxide gas | Active comparator | Device: Heated humidified carbon dioxide gasHeated humidified carbon dioxide gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.
- Capacity to consent
Key exclusion criteria (2 listed)
- Patients unable to speak English
- Patients unable to give consent
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 |
|---|---|---|
| Standard cold carbon dioxide gasUse of standard cold carbon dioxide gas in laparoscopic gynaecological surgery. | Device | Standard cold carbon dioxide gas |
| Heated humidified carbon dioxide gasUse of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery. | Device | Heated humidified carbon dioxide gas |
Primary outcome
Shoulder tip pain
Time frame: 8 hours
Shoulder tip pain recorded as a visual analogue scale from 1-10, 8 hours post surgery compared to baseline
2 secondary outcomes
General abdominal pain, nausea, vomiting and analgesia requirements
Time frame: 8 hours
Shoulder tip pain, general abdominal pain, nausea, vomiting.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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.
Fevzi Shakir, MBBS BSc MRCOG contact
Andrew Kent, TD MD FRCOG contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard cold carbon dioxide gas and Heated humidified carbon dioxide gas in people with Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery, run by Fevzi Shakir 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 3 inclusion and 2 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 18 Dec 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Fevzi Shakir, MBBS BSc MRCOG (fevzi@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder tip pain (time frame: 8 hours). 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 18 Dec 2014.