Abdominal Aortic Diameter During Laparoscopic SurgeryNCT01137500
Changes in Aortic Diameter During Laparoscopic Surgery
An observational study of Abdominal Aortic Diameter During Laparoscopic Surgery, run by Royal Surrey County Hospital NHS Foundation Trust.
Trial summary
Various haemodynamic changes are observed during laparoscopic surgery, relating to insufflation of CO2 \& patient position. Cardiac output calculations using oesophageal doppler monitoring are based on the assumption that the aortic diameter is fixed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Diameter During Laparoscopic Surgery
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2010to 3 Aug 2010
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study
Who may be able to join
- All adult patients undergoing elective laparoscopic surgery at the Royal Surrey County Hospital
Who cannot join
- Patient refusal
- Surgical refusal
- Conversion to an open procedure
About this study
Official title: Ultrasonic Assessment of Changes in Aortic Diameter During Laparoscopic Surgery
Various haemodynamic changes are observed during laparoscopic surgery, relating to insufflation of CO2 \& patient position. Cardiac output calculations using oesophageal doppler monitoring are based on the assumption that the aortic diameter is fixed. This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.
Read the detailed description
Purpose and design:This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.
Recruitment: Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study.
Inclusion / exclusion: Patient refusal, Surgical refusal, Conversion to an open procedure.
Consent: Informed consent will be gained from each participant.
Risks, burdens and benefits: This is an observational study using a non invasive technique in patients undergoing elective surgery. There is very little in the way of risks, burdens and benefits to the patient.
Confidentiality: Caldicott principles will be adhered to.
Conflict of interest: None.
Use of tissue samples in future research: None.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study start1 Aug 2010
- Primary completion2 Aug 2010
- Study completion3 Aug 2010
Why it stopped: host site logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Diameter During 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Matthew Dickinson, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Matthew C Dickinson, MB BS, Principal investigator, Royal Surrey County Hospital NHS Foundation TrustMike Scott, MB BS, Study director, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137500
- Sponsor's protocol ID
- RSCHanaes001
- Status last verified
- Aug 2018
- First submitted
- 3 Jun 2010
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Assessment of Changes in Aortic Diameter During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01137500
- Acronym / sponsor ID
- RSCHanaes001
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: host site logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 2 Aug 2010 (actual)
- Study completion
- 3 Aug 2010 (actual)
- First posted
- 4 Jun 2010 (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.
Various haemodynamic changes are observed during laparoscopic surgery, relating to insufflation of CO2 \& patient position. Cardiac output calculations using oesophageal doppler monitoring are based on the assumption that the aortic diameter is fixed. This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.
Detailed description
Purpose and design:This study aims to measure the aortic diameter at preset times during surgery using ultrasound to discover if the diameter remains the same, and hence if the assumptions made by the oesophageal monitor are reliable. Assessing the aortic diameter involves a noninvasive ultrasound measurement taken in patients electively having laparoscopic procedures at the Royal Surrey County Hospital.
Recruitment: Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study.
Inclusion / exclusion: Patient refusal, Surgical refusal, Conversion to an open procedure.
Consent: Informed consent will be gained from each participant.
Risks, burdens and benefits: This is an observational study using a non invasive technique in patients undergoing elective surgery. There is very little in the way of risks, burdens and benefits to the patient.
Confidentiality: Caldicott principles will be adhered to.
Conflict of interest: None.
Use of tissue samples in future research: None.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective laparoscopic procedures at the Royal Surrey County Hospital. Recruitment done by Dr M Dickinson or Dr M Scott (COnsultant Anaesthetists). No therapeutic promises are to be made as this is purely an observational study
Key inclusion criteria (1 listed)
- All adult patients undergoing elective laparoscopic surgery at the Royal Surrey County Hospital
Key exclusion criteria (3 listed)
- Patient refusal
- Surgical refusal
- Conversion to an open procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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.
Matthew C Dickinson, MB BS principal investigator
Royal Surrey County Hospital NHS Foundation Trust
Mike Scott, MB BS study director
Royal Surrey County Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Diameter During Laparoscopic Surgery, run by Royal Surrey County Hospital NHS Foundation Trust.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 31 Aug 2018.