Ventral HerniaNCT03296475
Intraoperative Biomechanics in Complex Abdominal Wall Reconstruction
A study testing Abdominal Wall Closure Force (N). in people with Ventral Hernia and Abdominal Wall Defect, run by University College, London at 1 site in United Kingdom.
Trial summary
Background: A detailed study of the biomechanical changes before and after abdominal wall reconstruction (AWR) has not been performed. Changes in abdominal wall tension and intra-abdominal pressure have physiological consequences on respiratory and cardiology function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia, Abdominal Wall Defect
- What is being tested?
- Abdominal Wall Closure Force (N).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2018to 1 Dec 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with midline hernia defects. Only patients with one or more midline defect will be included. For our study, we will define a midline hernia as herniation through the linea alba and with the rectus muscles falling either side of the hernia. The pre-operative CT scan will be used to study the hernia morphology and to see whether the patient fulfills these criteria.
- Patients undergoing primary or incisional ventral hernia repair, without formation of or closure of a stoma.
- Patients with either a maximal ventral hernia axial width of greater than 5cm or a loss of domain of greater then 20%, as measured on their pre-operative CT or MRI scan. The loss of domain will be measured using the patients' preoperative CT or MRI scan following the method of Tanaka et al.
- Patients aged ≥ 18 years old.
- Midline hernias closed in the midline with primary fascial closure with or without mesh augmentation. Any reconstruction technique can be used (e.g. anterior or posterior component separation) as long as primary fascial closure is achieved. The mesh may be placed in either the retro-rectus position (with or without a transverse abdominis release) or the onlay position.
- Participants who have a synthetic or bio-synthetic mesh implanted.
- Midline ventral hernias of VHWG grade 2 or 3. Clean and or Clean-contaminated wound classification.
- The participant is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to take part and has duly signed the consent form.
Who cannot join
- Emergency/Redo surgery.
- Defects not in the midline. Patients with one or more defect not through the linea alba on the pre-operative CT scan.
- AWR for abdominal wall sarcoma, invasive intra-abdominal carcinoma or other malignant disease.
- Contaminated VHWG grade 4 hernias. Or Contaminated or Dirty wound according to the CDC wound classification system.
- Concomitant procedures such as bowel resection.
- The hernia requires a bridged repair.
Show all 13Show fewer
- Individuals with co-morbid respiratory disease requiring oral corticosteroids or home oxygen therapy.
- Individuals who require the mesh to be placed in the intra-abdominal position.
- A patient with active peritonitis or an active mesh or subcutaneous infection.
- Individuals with a diagnosis of Crohn's disease.
- Individuals of American Society of Anesthesiology grade 4 or 5.
- Complete removal of an existing synthetic mesh (or biosynthetic mesh if not absorb) from a prior hernia repair in the same location is not possible.
- Participants with human immunodeficiency virus (HIV), known liver cirrhosis or alcohol abuse with a known relapse within 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Intra-operative Biomechanics in Complex Abdominal Wall Reconstruction: Do Changes in Abdominal Biomechanics Correlate With Significant Changes in Lung Compliance and Respiratory Function?
Background: A detailed study of the biomechanical changes before and after abdominal wall reconstruction (AWR) has not been performed. Changes in abdominal wall tension and intra-abdominal pressure have physiological consequences on respiratory and cardiology function. AWR surgeons currently do not know if they are applying too much tension when re-aligning the abdominal wall muscles during AWR. Too much tension is likely to cause respiratory and cardiac post-operative complications. The investigators propose to study the perioperative changes in abdominal biomechanics and cardiorespiratory physiology after AWR. In addition, investigators will also analyze the pre-operative patient CT scan to see if there any CT predictors of post-operative cardiorespiratory complications and hernia recurrence. The researchers hypothesize that there is a threshold value or force at which ventral hernias are repaired 'too tight' subjecting the patient to the increased risk of recurrence and cardiorespiratory complications.
Method: An in depth biomechanical and physiological study of 18-22 participants with midline ventral hernias will be carried out. Ventral hernias at least 5cm in width and only those in which primary fascial closure have been achieved will be included. Any operative technique used to achieve primary fascial closure will be included. Biomechanical and physiological measurements will be taken at five separate stages during the course of the patients' abdominal wall reconstruction. The final lung function tests, taken six weeks post op, will be compared to the patients' pre-operative tests. Meticulous attention will be paid to the study protocol making sure that in each patient the measurements are all taken at the same time and under the same conditions.
Discussion: This full biomechanical and physiological work up will enable AWR surgeons to assess when an AWR patient is subjected to too much biomechanical and physiological stress. The abdominal wall tension and strain will be measured to see if this predicts post complications and hernia recurrence.
- Conditions
- Ventral Hernia, Abdominal Wall Defect
- Being tested
- Abdominal Wall Closure Force (N).
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Wall Closure Force (N).Procedure or surgery
This measurement will be recorded for both the right and left anterior rectus sheath. We will measure this force at three anatomical points 1) at the level of the umbilicus and 2) at the halfway point between the pubic symphysis and the xiphisternum and 3) at the point of maximal hernia defect width.
| Study group | Role | What they receive |
|---|---|---|
| Midline Ventral Hernia | Experimental | Main inclusion criteria:
* Patients with midline hernia defects.
* Patients with either a maximal ventral hernia axial width of greater than 5cm or a loss of domain of greater then 20%.
* Patients aged ≥ 18 years old.
* Midline hernias closed in the midline with primary fascial closure with or without mesh augmentation.
* Midline ventral hernias of VHWG grade 2 or 3. Receives: Procedure: Abdominal Wall Closure Force (N). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Lung Compliance (measured in ml/cmH2O)
The primary outcome is the difference in Lung Compliance between stages 3 and 4 of the peri-operative protocol. i.e. we will measure the change in dynamic lung compliance before (after adhesiolysis) and after abdominal wall closure. We will measure this with a standard operative ventilator. Every patient will have a definitive airway (ET tube) fitted.
Measured: Day 1. Both measurements will be taken on the participants first day of the study. (Study enrollment will take place on the day of the participants operation.
Secondary outcomes (17)
Perioperative changes in Total Lung Capacity (Litres)
Total Lung Capacity (TLC) (Litres). TLC will be measured using spirometry before and after the patients AWR operation.
Measured: TLC will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Force Expiratory Volume (Litres)
Force Expiratory Volume over 1 second, FEV1 (Litres). FEV1 will be measured using spirometry before and after the patients AWR operation.
Measured: FEV1 will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Tidal Volume (Litres)
Tidal Volume, VT (Litres). VT will be measured using spirometry before and after the patients AWR operation.
Measured: VT will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Residual Volume (Litres)
Residual Volume, RV (Litres). RV will be measured using spirometry before and after the patients AWR operation.
Measured: RV will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Peak Expiratory Flow (Litres/min)
Peak Expiratory Flow, PEF (Litres/min). PEF will be measured using spirometry before and after the patients AWR operation.
Measured: PEF will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Dynamic Lung Compliance (ml/cmH2O)
Dynamic Lung Compliance, LC (ml/cmH2O). LC will be measured using spirometry before and after the patients AWR operation.
Measured: LC will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Abdominal wall closure force before abdominal wall closure (Newtons)
Measured in Newtons (N) with a Mecmesin Newton meter. After adhesiolysis (stage 3) and before abdominal wall closure.
Measured: Day 1. These abdominal wall closure measurements will be taken during the participants operation on the first day of the study. i.e. after enrollment, which will take place on the day of their operation.
Abdominal wall strain index (no units) (this is a strain index, change in transverse length (cm) / original transverse length of abdominal wall (cm))
Calculated using the pre-operative CT or MRI and by recording the hernia defect width intra-operatively.
Measured: Day 1. Defect width readings taken during the abdominal wall reconstruction operation
Ventral hernia recurrence
Rate of ventral hernia recurrence at 1 year, defined by clinical examination and supplemented by cross-sectional imaging where there is diagnostic uncertainty. Recurrence will be defined using the European classification for ventral hernia recurrence.
Measured: At 1 year after the patients operation.
Perioperative change in Intra-abdominal pressure (IAP) (mmHg)
Intra-abdominal pressure IAP (mmHg) will be measured using a transducer probe inserted into the bevel of a urinary catheter. The bladder will be inflated with 50ml of normal saline solution, the catheter will be clamped off distal to the position of the transducer/bevel. The bag of normal saline will be lowered to the level of the bladder when the IAP readings are taken. IAP reading will be taken at stages 2, 3 and 4 of our protocol (ie after induction of anaesthetic, after adhesiolysis, and after abdominal wall closure).
Measured: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in cardiac output (CO) (L/min)
Each participant will be fitted with an oesophageal doppler probe during their operation. This will measure the cardiac output. CO readings will be taken at stages 2, 3 and 4 of our protocol (ie after induction of anaesthetic, after adhesiolysis, and after abdominal wall closure).
Measured: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in stroke volume (SV) (L)
Each participant will be fitted with an oesophageal doppler probe during their operation. This will measure the cardiac stroke volume. SV readings will be taken at stages 2, 3 and 4 of our protocol (ie after induction of anaesthetic, after adhesiolysis, and after abdominal wall closure).
Measured: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in positive-end expiratory pressure (PEEP) (cm/H2O)
Positive-end expiratory pressure (PEEP) (cm/H2O) will be measured using the operative ventilator during the patient's operation. PEEP readings will be taken at stages 2, 3 and 4 of our protocol (ie after induction of anaesthetic, after adhesiolysis, and after abdominal wall closure).
Measured: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in fraction of inspired oxygen (fraction or as a per cent)
Fraction of inspired oxygen (FiO2) will be measured using the operative ventilator during the patient's operation. FiO2 readings will be taken at stages 2, 3 and 4 of our protocol (ie after induction of anaesthetic, after adhesiolysis, and after abdominal wall closure).
Measured: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative physiological changes in partial pressure of oxygen (pO2) (kPA)
Blood partial pressure of oxygen (pO2) (kPA) will be measured from arterial gas samples that will be taken from the patients arterial line during the operation.
pO2 readings will be taken at stages 2, 3 and 4 of our protocol (ie after induction of anaesthetic, after adhesiolysis, and after abdominal wall closure).
Measured: Day 1. Readings taken during the abdominal wall reconstruction operation
Rates of (a) intra-operative, (b) early post-operative (within 30 days of operation) and (c) late post-operative complications.
Early and late complications will be grouped into local wound complications (e.g. wound infection, seroma etc) and systemic complications (e.g. pneumonia, myocardial infarction etc). We will follow the Clavien-Dindo classification scheme.
Measured: Up to 3 years after the patients operation.
Ventral hernia recurrence
Rate of ventral hernia recurrence at 3 years, defined by clinical examination and supplemented by cross-sectional imaging where there is diagnostic uncertainty. Recurrence will be defined using the European classification for ventral hernia recurrence.
Measured: At 3 year after the patients operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start9 Jan 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm prospective cohort study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Suzanne Emerton, BA, Study director, Joint Research Office, University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296475
- Sponsor's protocol ID
- 17/0344
- Status last verified
- May 2018
- First submitted
- 5 Sep 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Designated members of the research team will be responsible for data entry at different steps of the patient pathway. All researchers will be responsible for the accuracy of the documentation and must ensure that all entries can be verified by the source data. An explanation will be given for all missing data. All the study documents and proformas containing the participant data will be kept on site in the General Surgery department at our hospital. At no point, will these documents be removed from the department. Study data will be pseudo-anonymised for data analysis. The file containing the pseudo-anonymised data will be password protected. Only the pseudo-anonymised data will leave the hospital department, it will be transferred using the secure UCLH.nhs.uk and NHS.net email systems. Only the primary researcher, SGP, will have access to the pseudo-anonymised data outside our hospital department, where the password protected data file will be keep on his secure personal laptop.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Intra-operative Biomechanics in Complex Abdominal Wall Reconstruction: Do Changes in Abdominal Biomechanics Correlate With Significant Changes in Lung Compliance and Respiratory Function?
- ClinicalTrials.gov ID
- NCT03296475
- Acronym / sponsor ID
- 17/0344
- Conditions
- Ventral Hernia, Abdominal Wall Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 28 Sep 2017 (actual)
- 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.
Background: A detailed study of the biomechanical changes before and after abdominal wall reconstruction (AWR) has not been performed. Changes in abdominal wall tension and intra-abdominal pressure have physiological consequences on respiratory and cardiology function. AWR surgeons currently do not know if they are applying too much tension when re-aligning the abdominal wall muscles during AWR. Too much tension is likely to cause respiratory and cardiac post-operative complications. The investigators propose to study the perioperative changes in abdominal biomechanics and cardiorespiratory physiology after AWR. In addition, investigators will also analyze the pre-operative patient CT scan to see if there any CT predictors of post-operative cardiorespiratory complications and hernia recurrence. The researchers hypothesize that there is a threshold value or force at which ventral hernias are repaired 'too tight' subjecting the patient to the increased risk of recurrence and cardiorespiratory complications.
Method: An in depth biomechanical and physiological study of 18-22 participants with midline ventral hernias will be carried out. Ventral hernias at least 5cm in width and only those in which primary fascial closure have been achieved will be included. Any operative technique used to achieve primary fascial closure will be included. Biomechanical and physiological measurements will be taken at five separate stages during the course of the patients' abdominal wall reconstruction. The final lung function tests, taken six weeks post op, will be compared to the patients' pre-operative tests. Meticulous attention will be paid to the study protocol making sure that in each patient the measurements are all taken at the same time and under the same conditions.
Discussion: This full biomechanical and physiological work up will enable AWR surgeons to assess when an AWR patient is subjected to too much biomechanical and physiological stress. The abdominal wall tension and strain will be measured to see if this predicts post complications and hernia recurrence.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Midline Ventral Hernia | Experimental | Procedure: Abdominal Wall Closure Force (N).Main inclusion criteria: * Patients with midline hernia defects. * Patients with either a maximal ventral hernia axial width of greater than 5cm or a loss of domain of greater then 20%. * Patients aged ≥ 18 years old. * Midline hernias closed in the midline with primary fascial closure with or without mesh augmentation. * Midline ventral hernias of VHWG grade 2 or 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with midline hernia defects. Only patients with one or more midline defect will be included. For our study, we will define a midline hernia as herniation through the linea alba and with the rectus muscles falling either side of the hernia. The pre-operative CT scan will be used to study the hernia morphology and to see whether the patient fulfills these criteria.
- Patients undergoing primary or incisional ventral hernia repair, without formation of or closure of a stoma.
- Patients with either a maximal ventral hernia axial width of greater than 5cm or a loss of domain of greater then 20%, as measured on their pre-operative CT or MRI scan. The loss of domain will be measured using the patients' preoperative CT or MRI scan following the method of Tanaka et al.
- Patients aged ≥ 18 years old.
- Midline hernias closed in the midline with primary fascial closure with or without mesh augmentation. Any reconstruction technique can be used (e.g. anterior or posterior component separation) as long as primary fascial closure is achieved. The mesh may be placed in either the retro-rectus position (with or without a transverse abdominis release) or the onlay position.
Key exclusion criteria (13 listed)
- Emergency/Redo surgery.
- Defects not in the midline. Patients with one or more defect not through the linea alba on the pre-operative CT scan.
- AWR for abdominal wall sarcoma, invasive intra-abdominal carcinoma or other malignant disease.
- Contaminated VHWG grade 4 hernias. Or Contaminated or Dirty wound according to the CDC wound classification system.
- Concomitant procedures such as bowel resection.
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 |
|---|---|---|
| Abdominal Wall Closure Force (N).This measurement will be recorded for both the right and left anterior rectus sheath. We will measure this force at three anatomical points 1) at the level of the umbilicus and 2) at the halfway point between the pubic symphysis and the xiphisternum and 3) at the point of maximal hernia defect width. | Procedure or surgery | Midline Ventral Hernia |
Primary outcome
Dynamic Lung Compliance (measured in ml/cmH2O)
Time frame: Day 1. Both measurements will be taken on the participants first day of the study. (Study enrollment will take place on the day of the participants operation.
The primary outcome is the difference in Lung Compliance between stages 3 and 4 of the peri-operative protocol. i.e. we will measure the change in dynamic lung compliance before (after adhesiolysis) and after abdominal wall closure. We will measure this with a standard operative ventilator. Every patient will have a definitive airway (ET tube) fitted.
17 secondary outcomes
Perioperative changes in Total Lung Capacity (Litres)
Time frame: TLC will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Force Expiratory Volume (Litres)
Time frame: FEV1 will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Tidal Volume (Litres)
Time frame: VT will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Residual Volume (Litres)
Time frame: RV will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Peak Expiratory Flow (Litres/min)
Time frame: PEF will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Perioperative changes in Dynamic Lung Compliance (ml/cmH2O)
Time frame: LC will be measured on Day 1 and at 6 weeks, 12 months and 3 years after the patients operation.
Abdominal wall closure force before abdominal wall closure (Newtons)
Time frame: Day 1. These abdominal wall closure measurements will be taken during the participants operation on the first day of the study. i.e. after enrollment, which will take place on the day of their operation.
Abdominal wall strain index (no units) (this is a strain index, change in transverse length (cm) / original transverse length of abdominal wall (cm))
Time frame: Day 1. Defect width readings taken during the abdominal wall reconstruction operation
Ventral hernia recurrence
Time frame: At 1 year after the patients operation.
Perioperative change in Intra-abdominal pressure (IAP) (mmHg)
Time frame: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in cardiac output (CO) (L/min)
Time frame: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in stroke volume (SV) (L)
Time frame: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in positive-end expiratory pressure (PEEP) (cm/H2O)
Time frame: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative change in fraction of inspired oxygen (fraction or as a per cent)
Time frame: Day 1. Readings taken during the abdominal wall reconstruction operation
Perioperative physiological changes in partial pressure of oxygen (pO2) (kPA)
Time frame: Day 1. Readings taken during the abdominal wall reconstruction operation
Rates of (a) intra-operative, (b) early post-operative (within 30 days of operation) and (c) late post-operative complications.
Time frame: Up to 3 years after the patients operation.
Ventral hernia recurrence
Time frame: At 3 year after the patients operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: No. Designated members of the research team will be responsible for data entry at different steps of the patient pathway. All researchers will be responsible for the accuracy of the documentation and must ensure that all entries can be verified by the source data. An explanation will be given for all missing data. All the study documents and proformas containing the participant data will be kept on site in the General Surgery department at our hospital. At no point, will these documents be removed from the department. Study data will be pseudo-anonymised for data analysis. The file containing the pseudo-anonymised data will be password protected. Only the pseudo-anonymised data will leave the hospital department, it will be transferred using the secure UCLH.nhs.uk and NHS.net email systems. Only the primary researcher, SGP, will have access to the pseudo-anonymised data outside our hospital department, where the password protected data file will be keep on his secure personal laptop.
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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.
Suzanne Emerton, BA study director
Joint Research Office, University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Wall Closure Force (N). in people with Ventral Hernia and Abdominal Wall Defect, run by University College, London 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 8 inclusion and 13 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 31 May 2018. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Lung Compliance (measured in ml/cmH2O) (time frame: Day 1. Both measurements will be taken on the participants first day of the study. (Study enrollment will take place on the day of the participants operation.). 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 31 May 2018.