Changes in Aortic Diameter During Laparoscopic Surgery | NCT01137500

Studies
Changes in Aortic Diameter During Laparoscopic Surgery

NCT01137500

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Status

Withdrawn

Last Update Posted

Aug 31, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Abdominal Aortic Diameter During Laparoscopic Surgery

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

host site logistical problems

Expanded Access Info

Start Date

Aug 1, 2010Actual

Primary Completion Date

Aug 2, 2010Actual

Completion Date

Aug 3, 2010Actual

First Submitted Date

Jun 3, 2010

First Submission Date that Met QC Criteria

Jun 3, 2010

First Posted Date

Jun 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2018

Last Update Posted Date

Aug 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Matthew Dickinson, Anaesthetist, Royal Surrey County Hospital NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Royal Surrey County Hospital NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients undergoing elective laparoscopic surgery at the Royal Surrey County Hospital

Exclusion Criteria:

Patient refusal
Surgical refusal
Conversion to an open procedure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew C Dickinson, MB BS	Royal Surrey County Hospital NHS Foundation Trust	Principal Investigator
Mike Scott, MB BS	Royal Surrey County Hospital NHS Foundation Trust	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided