Colorectal CancerRADOXNCT02045680
RADOX' Reduced Abdominal Distension and Oxygen Delivery
An observational study of Colorectal Cancer, run by Dr Michael Scott at 1 site in United Kingdom.
Trial summary
The use of laparoscopic surgery is continuing to increase in colorectal resection and expected reach 80% in the next 10 years. Although laparoscopic (keyhole) or minimally invasive surgery can lead to faster recovery it can also put significant stresses on the patient's heart and cause fluctuations in blood pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective laparoscopic colorectal surgery over the age of 18years
Who may be able to join
- Patients over 18 years of age
- Planned elective major abdominal surgery for laparoscopic resection of colorectal cancer on the enhanced recovery programme with use of neuromuscular block Capacity to consent
Who cannot join
- Known oesophageal disease as a contraindication to using oesophageal Doppler probe
- Known allergy/hypersensitivity to rocuronium, sugammadex or other drugs to be given in protocol.
- Significant neuromuscular disease Insulin dependent diabetes with or without known autonomic dysreflexia
- Any known dysautonomia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
Michael Scott, +441483464116, mjpscott@btinternet.com
Sarah Tracey, +441483688548, stracey@nhs.net
About this study
Official title: Haemodynamic Changes and Oxygen Delivery in Patients Undergoing Laparoscopic Colorectal Surgery With Deep Neuromuscular Block
The use of laparoscopic surgery is continuing to increase in colorectal resection and expected reach 80% in the next 10 years. Although laparoscopic (keyhole) or minimally invasive surgery can lead to faster recovery it can also put significant stresses on the patient's heart and cause fluctuations in blood pressure due to the extreme headdown positioning and abdominal insufflation of carbon dioxide gas.
We have performed several surgical cases under deep neuromuscular block and this has allowed surgery to operate at lower abdominal pressures (from 14 down to 8 mmHg). This put less strain on the heart and allowed higher cardiac outputs.
Read more
This study will look at whether deep neuromuscular block is beneficial for patients by
- Increasing oxygen delivery, measured using oesophageal doppler monitoring of cardiovascular variables intraoperatively
- Allowing surgery at lower abdominal insufflation pressures if they have a deep block
- Reducing patient's analgesic requirements postoperatively in recovery and at 4 hours
Read the detailed description
Design pilot study, single arm controlled study Hypothesis Deep neuromuscular blockade provided intraoperatively for patients undergoing laparoscopic colorectal surgery will have an increase in oxygen delivery as measured by haemodynamic data using oesophageal doppler. Secondary hypotheses Deep muscular blockade will provide the same surgical operating conditions at lower abdominal inflation pressures. The patients will experience less pain postoperatively due to less forced distension of the peritoneum demonstrated by less analgesic requirements. Patients will therefore spend less time in recovery and be able to mobilise earlier.Participants and Recruitment Patients will be assessed in preassessment clinic by a clinical nurse specialist for eligibility and provided with a patient information sheet. On the morning of planned surgery patients eligible who wish to be included in the study will be consented for the study in accordance with the International GCP guidelines by the anaesthetic researcher, and given a form to sign.
Sample size We estimate that 30- 40 participants will be required to demonstrate and statistical significance. Our unit carries out approximately 4 laparoscopic colorectal resections per week. Assuming that 30% of patients may not consent to participation or will not meet inclusion criteria we predict it will take less than 6- 12 months to enrol the necessary number of participants.
Preoperatively Participants will already be on the standardised Enhanced Recovery Programme. Intraoperatively An oesophageal Doppler probe will be inserted orally or nasally (standard practice in our unit for haemodynamic monitoring) to titrate fluids using stroke volume optimisation protocol (as per normal practice). Cardiovascular variables (heart rate, stroke volume, blood pressure and corrected flow time) will be collected prior to commencing surgery to provide baseline data set and throughout the procedure in accordance with routine observations under anaesthesia, which will together calculate oxygen delivery. Abdominal pressure will be measured continuously during insufflation and maintenance of the pneumoperitoneum (as per standard practice). Abdominal insufflation pressure will be gradually reduced as low as possible but ensuring the same standard of surgical access and operating conditions. Following completion of surgery the neuromuscular blockade will be reversed using a standardised dose of sugammadex 4mg/ kg according to the manufacturers guidelines according to neuromuscular monitoring returns a double burst stimulus to normal.
Postoperatively Immediately in the recovery area analgesia will be provided in accordance with enhanced recovery guidelines. Morphine Sulphate will be titrated to effect and a patient controlled analgesia pump given to the patient, which records quantity and demands of morphine used. .The standard enhanced recovery pathway will then be continued until discharge home.
Outcome measures Data collection for the primary endpoint will be collected from the haemodynamic data captured in theatre using the anaesthetic chart recording and oesophageal doppler. Data for the secondary endpoints will be pain scores in recovery and at 4 hours post operatively. Other secondary endpoints will be collected as standard by the Enhanced Recovery Nurse. These will include: length of operation, time spent in recovery area after surgery, time taken until mobilisation.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, laparoscopy, neuromuscular block, oxygen delivery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| deep block | deep block | |
| non deep block (historical control) | non deep block (historical control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved tissue oxygen delivery
Improved tissue oxygen delivery during laparoscopic surgery in patients treated with deep neuromuscular blockade with lower operative abdominal pressures.
Measured: Duration of surgery
Secondary outcomes (3)
Reduction in patient pain scores following surgery
Pain scores in recovery area following surgery using the standard Royal Surrey pain scoring system. This will continue three times a day for 48 hours
Measured: first 48 hours after surgery
Time spent in recovery until fit for discharge to the wards following surgery
Measured: Number of minutes in recovery before being discharged
Time taken for patient to first mobilise following surgery
time taken in minutes until mobilisation achieved
Measured: First mobilisation following surgery -
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Michael Scott
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Dr Michael Scott, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- michael Scott, MB ChB, Principal investigator, Royal Surrey County Hospital, Guildford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045680
- Sponsor's protocol ID
- 13SURN0014
- Other IDs
- MISP Database 50339
- Acronym
- RADOX
- Status last verified
- Sep 2014
- First submitted
- 17 Dec 2013
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levy BF, Fawcett WJ, Scott MJ, Rockall TA. Intra-operative oxygen delivery in infusion volume-optimized patients undergoing laparoscopic colorectal surgery within an enhanced recovery programme: the effect of different analgesic modalities. Colorectal Dis. 2012 Jul;14(7):887-92. doi: 10.1111/j.1463-1318.2011.02805.x.
PubMed 21895923
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Changes and Oxygen Delivery in Patients Undergoing Laparoscopic Colorectal Surgery With Deep Neuromuscular Block
- ClinicalTrials.gov ID
- NCT02045680
- Acronym / sponsor ID
- RADOX / 13SURN0014
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, laparoscopy, neuromuscular block, oxygen delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dr Michael ScottUniversity, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust, Merck Sharp & Dohme LLC
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Jan 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.
The use of laparoscopic surgery is continuing to increase in colorectal resection and expected reach 80% in the next 10 years. Although laparoscopic (keyhole) or minimally invasive surgery can lead to faster recovery it can also put significant stresses on the patient's heart and cause fluctuations in blood pressure due to the extreme headdown positioning and abdominal insufflation of carbon dioxide gas.
We have performed several surgical cases under deep neuromuscular block and this has allowed surgery to operate at lower abdominal pressures (from 14 down to 8 mmHg). This put less strain on the heart and allowed higher cardiac outputs.
This study will look at whether deep neuromuscular block is beneficial for patients by
- Increasing oxygen delivery, measured using oesophageal doppler monitoring of cardiovascular variables intraoperatively
- Allowing surgery at lower abdominal insufflation pressures if they have a deep block
- Reducing patient's analgesic requirements postoperatively in recovery and at 4 hours
Detailed description
Design pilot study, single arm controlled study Hypothesis Deep neuromuscular blockade provided intraoperatively for patients undergoing laparoscopic colorectal surgery will have an increase in oxygen delivery as measured by haemodynamic data using oesophageal doppler. Secondary hypotheses Deep muscular blockade will provide the same surgical operating conditions at lower abdominal inflation pressures. The patients will experience less pain postoperatively due to less forced distension of the peritoneum demonstrated by less analgesic requirements. Patients will therefore spend less time in recovery and be able to mobilise earlier.Participants and Recruitment Patients will be assessed in preassessment clinic by a clinical nurse specialist for eligibility and provided with a patient information sheet. On the morning of planned surgery patients eligible who wish to be included in the study will be consented for the study in accordance with the International GCP guidelines by the anaesthetic researcher, and given a form to sign.
Sample size We estimate that 30- 40 participants will be required to demonstrate and statistical significance. Our unit carries out approximately 4 laparoscopic colorectal resections per week. Assuming that 30% of patients may not consent to participation or will not meet inclusion criteria we predict it will take less than 6- 12 months to enrol the necessary number of participants.
Preoperatively Participants will already be on the standardised Enhanced Recovery Programme. Intraoperatively An oesophageal Doppler probe will be inserted orally or nasally (standard practice in our unit for haemodynamic monitoring) to titrate fluids using stroke volume optimisation protocol (as per normal practice). Cardiovascular variables (heart rate, stroke volume, blood pressure and corrected flow time) will be collected prior to commencing surgery to provide baseline data set and throughout the procedure in accordance with routine observations under anaesthesia, which will together calculate oxygen delivery. Abdominal pressure will be measured continuously during insufflation and maintenance of the pneumoperitoneum (as per standard practice). Abdominal insufflation pressure will be gradually reduced as low as possible but ensuring the same standard of surgical access and operating conditions. Following completion of surgery the neuromuscular blockade will be reversed using a standardised dose of sugammadex 4mg/ kg according to the manufacturers guidelines according to neuromuscular monitoring returns a double burst stimulus to normal.
Postoperatively Immediately in the recovery area analgesia will be provided in accordance with enhanced recovery guidelines. Morphine Sulphate will be titrated to effect and a patient controlled analgesia pump given to the patient, which records quantity and demands of morphine used. .The standard enhanced recovery pathway will then be continued until discharge home.
Outcome measures Data collection for the primary endpoint will be collected from the haemodynamic data captured in theatre using the anaesthetic chart recording and oesophageal doppler. Data for the secondary endpoints will be pain scores in recovery and at 4 hours post operatively. Other secondary endpoints will be collected as standard by the Enhanced Recovery Nurse. These will include: length of operation, time spent in recovery area after surgery, time taken until mobilisation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep block | – | –deep block |
| non deep block (historical control) | – | –non deep block (historical control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective laparoscopic colorectal surgery over the age of 18years
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Planned elective major abdominal surgery for laparoscopic resection of colorectal cancer on the enhanced recovery programme with use of neuromuscular block Capacity to consent
Key exclusion criteria (4 listed)
- Known oesophageal disease as a contraindication to using oesophageal Doppler probe
- Known allergy/hypersensitivity to rocuronium, sugammadex or other drugs to be given in protocol.
- Significant neuromuscular disease Insulin dependent diabetes with or without known autonomic dysreflexia
- Any known dysautonomia
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
Improved tissue oxygen delivery
Time frame: Duration of surgery
Improved tissue oxygen delivery during laparoscopic surgery in patients treated with deep neuromuscular blockade with lower operative abdominal pressures.
3 secondary outcomes
Reduction in patient pain scores following surgery
Time frame: first 48 hours after surgery
Time spent in recovery until fit for discharge to the wards following surgery
Time frame: Number of minutes in recovery before being discharged
Time taken for patient to first mobilise following surgery
Time frame: First mobilisation following surgery -
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Results publication: PubMed 21895923Levy BF, Fawcett WJ, Scott MJ, Rockall TA. Intra-operative oxygen delivery in infusion volume-optimized patients undergoing laparoscopic colorectal surgery within an enhanced recovery programme: the effect of different analgesic modalities. Colorectal Dis. 2012 Jul;14(7):887-92. doi: 10.1111/j.1463-1318.2011.02805.x.
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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.
michael Scott, MB ChB principal investigator
Royal Surrey County Hospital, Guildford, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Dr Michael Scott 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 4 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 5 Sep 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. 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 michael scott, Mb ChB (441483571122, mjpscott@btinternet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved tissue oxygen delivery (time frame: Duration of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045680, which also lists 1 linked publication.
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 5 Sep 2014.