Colorectal DisordersSAGENCT01924585
Surgery in Persons of Older Age
An observational study of Colorectal Disorders and Surgery, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years and older undergoing major colorectal surgery. That is to say we are looking at how older patients recovery following surgery, and that patients who volunteer to take part will absolutely not have any changes made to patients… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Disorders, Surgery, Old Age; Debility
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2012to Jul 2015
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 years or more, undergoing elective colorectal surgery (laparoscopic or open).
Who may be able to join
- All patients aged 60 years or older years undergoing elective major colorectal surgery.
Who cannot join
- Patients aged <60 years at time of operation.
- Severe cognitive impairment (Mini-mental score <18).
- Non-English language speaker.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
St Mark's Hospital, Northwick Park NHS Trust
Harrow, Middlesex, HA13UJ
Nigel M Bagnall, MBChB MRCS, +44(0)7881448854, nbagnall@imperial.ac.uk
Nigel M Bagnall, MBChB MRCS
- Recruiting
St Mary's Hospital
London, London, W21NY
Nigel M Bagnall, MBChB MRCS, +44(0)7881448854, nbagnall@imperial.ac.uk
Nigel M Bagnall, MBChB MRCS
About this study
Official title: Prospective Observational Study of Patients Aged >=60 Years Undergoing Major Gastrointestinal Surgery With 1 Year Follow-up
Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years and older undergoing major colorectal surgery. That is to say we are looking at how older patients recovery following surgery, and that patients who volunteer to take part will absolutely not have any changes made to patients planned treatment or surgery.
Patients (identified by their Consultant) will be asked if they would like to participate in the study, agreeing to undertake an additional questionnaire, blood test, provide a urine specimen and several basic physical tests during the pre-assessment visit taking an additional 30-45 minutes.
Read more
This will not affect their treatment in any way. Participation is voluntary.
At the time of the pre-assessment process the patient will then be approached by a researcher, who will explain the study in more detail and obtain written consent.
The questionnaire is a combination of questions, which have been used in other similar studies and may be used to identify people who are fitter than others to undergo surgery. These questions are not too dissimilar to those that may be asked during the pre-assessment process. In fact some hospitals use some of these questions (but not usually all) routinely during a hospital admission process.
Several basic physical tests will be performed: hand grip strength test and some basic walking and chair rising tests. These will be supervised by the trained researcher to ensure they are carried out safely.
A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for the standard pre-operative assessment process. We will also take urine specimens. The blood sample and urine specimens will be saved for tests later. There are several potential blood and urine tests that may be related to physical frailty/impairment and the aging process.
The patient will undergo surgery as planned and be discharged from hospital. No researcher will interfere with the planned care or conduct any data collection at this point.
At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at the time of their postoperative follow-up checks, then we will repeat the basic physical tests again also.
The patient's notes will be reviewed by a researcher (who is also a doctor) to see what operation was performed, the length of hospital stay, and if any problems developed. The patients GP may also be contacted if additional information is required.
This study, while based on several others, is the first of its kind to see how persons recover after surgery being assessed over one year.
We will recruit for 18 months across two hospitals aiming to recruit 200 patients during this time.
Read the detailed description
Background
Lifespans are increasing and the proportion of elderly persons undergoing surgery is increasing[1]. As clinicians we need to accurately communicate the risks of major surgery to our patients. Traditional risk prediction tools such as Physiologic and operative Severity Score for the enumeration of Mortality and Morbidity (POSSUM) estimate short-term outcomes[2]. Patients have the right to know the likely outcomes beyond the 30-day perioperative period, including life expectancy, long-term complications, level of independence and quality of life[3].
Based on a systematic review of the literature we have previously reported on the paucity of studies evaluating longer-term outcomes in persons of advanced age undergoing major surgery[4].
Our group has previously reported, from analysis performed on an English administrative dataset, that patients face comparatively high mortality of 29% at one year following colorectal surgery when performed as an emergency[5]. Furthermore, we have published findings, again from national datasets, that patients 75-80 years of age undergoing colorectal resection in the elective setting also face substantial mortality of 16% at one-year, and over a third of patients aged >89 years who underwent surgery did not survive one-year[6].
Frailty, a distinct entity from co-morbidity, is recognized as an independent contributor to mortality in elderly surgical patients[7-10]. Thus we need to improve preoperative risk stratification for geriatric patients. Such systems may include frailty assessment and relevant predictive biomarkers. Thus we can then target additional healthcare resources towards the most frail and vulnerable elderly patients to mitigate against the risks of postoperative complications and death[11].
Preoperative optimisation strategies [12-14], careful intraoperative monitoring and postoperative care within the high dependency setting may reduce the frequency of postoperative complications, accelerate recovery and improve short-term outcomes. Furthermore, we need a collaborative research with elderly care and community physicians to determine whether ongoing postoperative community rehabilitation can offset the late risk of death associated with major surgery and further improve long-term survival.
Rationale for Current Study: Research Question
What preoperative parameters can be used to predict patient centered outcomes (survival, complications, functional independence, quality of life) in older persons undergoing major gastrointestinal elective surgery in the intermediate term?
Hypotheses
Traditional POSSUM scoring systems will not reliably predict outcomes at 1 year in elderly persons.
Patients determined to be frail preoperatively will have worse outcomes at 1 year, in terms of survival, postoperative complications, level of independence and quality of life.
Study Objectives
To identify the preoperative parameters that will predict 1 year outcomes in patients aged ≥60 years undergoing major gastrointestinal elective surgery.
Parameters include comprehensive geriatric assessment (i.e. a preoperative questionnaire of validated instruments assessing the dimensions of co-morbidities, activities of daily living, nutrition, cognitive function, emotional status, fatigue and performance status).
Furthermore patients will be asked to undergo a series of simple physical exercises (hand grip strength, timing up and go, 15 feet timing walking test, and 6 minute walking test).
Preoperative serum results will also be incorporated. Additional blood and urine samples will be obtained preoperative for later metabolic profiling.
Questionnaire, physical tests and biological sampling with be assessed at the time of the preoperative assessment process, or at another time preoperatively at the patients convenience.
Serum samples will be only obtained preoperatively. Urine samples may be collected following surgery.
- Conditions
- Colorectal Disorders, Surgery, Old Age; Debility, Quality of Life, Complications
- Keywords
- Colorectal, Surgery, Frailty, Elderly, Quality of Life
- Medical subject headings
- Frailty
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 |
|---|---|---|
| Frail patient | Patients will be stratified into groups frail and non-frail based on pre-operative frailty and disability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Time to return to preoperative quality of life / level of functional independence.
Measured: Up to 1 Year Postoperatively
Secondary outcomes (6)
Complications
Clavien-Dindo complications
Measured: 30 days
All Cause Mortality
Measured: 30 days postoperatively
Length of Hospital Stay
Measured: Average 5-10 days
Reoperation/reintervention
Measured: 30 day postoperatively
Re-admission
Measured: 30 days post-operatively
Discharge destination
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by Imperial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nigel M Bagnall, MBChB MRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924585
- Sponsor's protocol ID
- 12/LO/1042-SAGE
- Acronym
- SAGE
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Etzioni DA, Liu JH, Maggard MA, Ko CY. The aging population and its impact on the surgery workforce. Ann Surg. 2003 Aug;238(2):170-7. doi: 10.1097/01.SLA.0000081085.98792.3d.
PubMed 12894008Al-Homoud S, Purkayastha S, Aziz O, Smith JJ, Thompson MD, Darzi AW, Stamatakis JD, Tekkis PP. Evaluating operative risk in colorectal cancer surgery: ASA and POSSUM-based predictive models. Surg Oncol. 2004 Aug-Nov;13(2-3):83-92. doi: 10.1016/j.suronc.2004.08.006.
PubMed 15572090Grocott MP, Pearse RM. Prognostic studies of perioperative risk: robust methodology is needed. Br J Anaesth. 2010 Sep;105(3):243-5. doi: 10.1093/bja/aeq207. No abstract available.
PubMed 20716567Mamidanna R, Almoudaris AM, Faiz O. Is 30-day mortality an appropriate measure of risk in elderly patients undergoing elective colorectal resection? Colorectal Dis. 2012 Oct;14(10):1175-82. doi: 10.1111/j.1463-1318.2011.02859.x.
PubMed 21999306Faiz O, Brown T, Bottle A, Burns EM, Darzi AW, Aylin P. Impact of hospital institutional volume on postoperative mortality after major emergency colorectal surgery in English National Health Service Trusts, 2001 to 2005. Dis Colon Rectum. 2010 Apr;53(4):393-401. doi: 10.1007/DCR.0b013e3181cc6fd2.
PubMed 20305437Faiz O, Haji A, Bottle A, Clark SK, Darzi AW, Aylin P. Elective colonic surgery for cancer in the elderly: an investigation into postoperative mortality in English NHS hospitals between 1996 and 2007. Colorectal Dis. 2011 Jul;13(7):779-85. doi: 10.1111/j.1463-1318.2010.02290.x. Epub 2010 Apr 19.
PubMed 20412094Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
PubMed 20510798Tan KY, Kawamura YJ, Tokomitsu A, Tang T. Assessment for frailty is useful for predicting morbidity in elderly patients undergoing colorectal cancer resection whose comorbidities are already optimized. Am J Surg. 2012 Aug;204(2):139-43. doi: 10.1016/j.amjsurg.2011.08.012. Epub 2011 Dec 16.
PubMed 22178483Sundermann S, Dademasch A, Rastan A, Praetorius J, Rodriguez H, Walther T, Mohr FW, Falk V. One-year follow-up of patients undergoing elective cardiac surgery assessed with the Comprehensive Assessment of Frailty test and its simplified form. Interact Cardiovasc Thorac Surg. 2011 Aug;13(2):119-23; discussion 123. doi: 10.1510/icvts.2010.251884. Epub 2011 Mar 4.
PubMed 21378017Robinson TN, Wu DS, Stiegmann GV, Moss M. Frailty predicts increased hospital and six-month healthcare cost following colorectal surgery in older adults. Am J Surg. 2011 Nov;202(5):511-4. doi: 10.1016/j.amjsurg.2011.06.017. Epub 2011 Sep 3.
PubMed 21890098Pearse RM, Holt PJ, Grocott MP. Managing perioperative risk in patients undergoing elective non-cardiac surgery. BMJ. 2011 Oct 5;343:d5759. doi: 10.1136/bmj.d5759. No abstract available.
PubMed 21976704Jack S, West M, Grocott MP. Perioperative exercise training in elderly subjects. Best Pract Res Clin Anaesthesiol. 2011 Sep;25(3):461-72. doi: 10.1016/j.bpa.2011.07.003.
PubMed 21925410Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
PubMed 20602503Hennis PJ, Meale PM, Grocott MP. Cardiopulmonary exercise testing for the evaluation of perioperative risk in non-cardiopulmonary surgery. Postgrad Med J. 2011 Aug;87(1030):550-7. doi: 10.1136/pgmj.2010.107185. Epub 2011 Jun 21.
PubMed 21693573
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Patients Aged >=60 Years Undergoing Major Gastrointestinal Surgery With 1 Year Follow-up
- ClinicalTrials.gov ID
- NCT01924585
- Acronym / sponsor ID
- SAGE / 12/LO/1042-SAGE
- Conditions
- Colorectal Disorders, Surgery, Old Age; Debility, Quality of Life, Complications
- Keywords
- Colorectal, Surgery, Frailty, Elderly, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 16 Aug 2013 (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.
Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years and older undergoing major colorectal surgery. That is to say we are looking at how older patients recovery following surgery, and that patients who volunteer to take part will absolutely not have any changes made to patients planned treatment or surgery.
Patients (identified by their Consultant) will be asked if they would like to participate in the study, agreeing to undertake an additional questionnaire, blood test, provide a urine specimen and several basic physical tests during the pre-assessment visit taking an additional 30-45 minutes.
This will not affect their treatment in any way. Participation is voluntary.
At the time of the pre-assessment process the patient will then be approached by a researcher, who will explain the study in more detail and obtain written consent.
The questionnaire is a combination of questions, which have been used in other similar studies and may be used to identify people who are fitter than others to undergo surgery. These questions are not too dissimilar to those that may be asked during the pre-assessment process. In fact some hospitals use some of these questions (but not usually all) routinely during a hospital admission process.
Several basic physical tests will be performed: hand grip strength test and some basic walking and chair rising tests. These will be supervised by the trained researcher to ensure they are carried out safely.
A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for the standard pre-operative assessment process. We will also take urine specimens. The blood sample and urine specimens will be saved for tests later. There are several potential blood and urine tests that may be related to physical frailty/impairment and the aging process.
The patient will undergo surgery as planned and be discharged from hospital. No researcher will interfere with the planned care or conduct any data collection at this point.
At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at the time of their postoperative follow-up checks, then we will repeat the basic physical tests again also.
The patient's notes will be reviewed by a researcher (who is also a doctor) to see what operation was performed, the length of hospital stay, and if any problems developed. The patients GP may also be contacted if additional information is required.
This study, while based on several others, is the first of its kind to see how persons recover after surgery being assessed over one year.
We will recruit for 18 months across two hospitals aiming to recruit 200 patients during this time.
Detailed description
Background
Lifespans are increasing and the proportion of elderly persons undergoing surgery is increasing[1]. As clinicians we need to accurately communicate the risks of major surgery to our patients. Traditional risk prediction tools such as Physiologic and operative Severity Score for the enumeration of Mortality and Morbidity (POSSUM) estimate short-term outcomes[2]. Patients have the right to know the likely outcomes beyond the 30-day perioperative period, including life expectancy, long-term complications, level of independence and quality of life[3].
Based on a systematic review of the literature we have previously reported on the paucity of studies evaluating longer-term outcomes in persons of advanced age undergoing major surgery[4].
Our group has previously reported, from analysis performed on an English administrative dataset, that patients face comparatively high mortality of 29% at one year following colorectal surgery when performed as an emergency[5]. Furthermore, we have published findings, again from national datasets, that patients 75-80 years of age undergoing colorectal resection in the elective setting also face substantial mortality of 16% at one-year, and over a third of patients aged >89 years who underwent surgery did not survive one-year[6].
Frailty, a distinct entity from co-morbidity, is recognized as an independent contributor to mortality in elderly surgical patients[7-10]. Thus we need to improve preoperative risk stratification for geriatric patients. Such systems may include frailty assessment and relevant predictive biomarkers. Thus we can then target additional healthcare resources towards the most frail and vulnerable elderly patients to mitigate against the risks of postoperative complications and death[11].
Preoperative optimisation strategies [12-14], careful intraoperative monitoring and postoperative care within the high dependency setting may reduce the frequency of postoperative complications, accelerate recovery and improve short-term outcomes. Furthermore, we need a collaborative research with elderly care and community physicians to determine whether ongoing postoperative community rehabilitation can offset the late risk of death associated with major surgery and further improve long-term survival.
Rationale for Current Study: Research Question
What preoperative parameters can be used to predict patient centered outcomes (survival, complications, functional independence, quality of life) in older persons undergoing major gastrointestinal elective surgery in the intermediate term?
Hypotheses
Traditional POSSUM scoring systems will not reliably predict outcomes at 1 year in elderly persons.
Patients determined to be frail preoperatively will have worse outcomes at 1 year, in terms of survival, postoperative complications, level of independence and quality of life.
Study Objectives
To identify the preoperative parameters that will predict 1 year outcomes in patients aged ≥60 years undergoing major gastrointestinal elective surgery.
Parameters include comprehensive geriatric assessment (i.e. a preoperative questionnaire of validated instruments assessing the dimensions of co-morbidities, activities of daily living, nutrition, cognitive function, emotional status, fatigue and performance status).
Furthermore patients will be asked to undergo a series of simple physical exercises (hand grip strength, timing up and go, 15 feet timing walking test, and 6 minute walking test).
Preoperative serum results will also be incorporated. Additional blood and urine samples will be obtained preoperative for later metabolic profiling.
Questionnaire, physical tests and biological sampling with be assessed at the time of the preoperative assessment process, or at another time preoperatively at the patients convenience.
Serum samples will be only obtained preoperatively. Urine samples may be collected following surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail patient | – | –Patients will be stratified into groups frail and non-frail based on pre-operative frailty and disability. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 years or more, undergoing elective colorectal surgery (laparoscopic or open).
Key inclusion criteria (1 listed)
- All patients aged 60 years or older years undergoing elective major colorectal surgery.
Key exclusion criteria (3 listed)
- Patients aged <60 years at time of operation.
- Severe cognitive impairment (Mini-mental score <18).
- Non-English language speaker.
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
Quality of Life
Time frame: Up to 1 Year Postoperatively
Time to return to preoperative quality of life / level of functional independence.
6 secondary outcomes
Complications
Time frame: 30 days
All Cause Mortality
Time frame: 30 days postoperatively
Length of Hospital Stay
Time frame: Average 5-10 days
Reoperation/reintervention
Time frame: 30 day postoperatively
Re-admission
Time frame: 30 days post-operatively
Discharge destination
Time frame: 30 days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Background: PubMed 12894008Etzioni DA, Liu JH, Maggard MA, Ko CY. The aging population and its impact on the surgery workforce. Ann Surg. 2003 Aug;238(2):170-7. doi: 10.1097/01.SLA.0000081085.98792.3d.
- Background: PubMed 15572090Al-Homoud S, Purkayastha S, Aziz O, Smith JJ, Thompson MD, Darzi AW, Stamatakis JD, Tekkis PP. Evaluating operative risk in colorectal cancer surgery: ASA and POSSUM-based predictive models. Surg Oncol. 2004 Aug-Nov;13(2-3):83-92. doi: 10.1016/j.suronc.2004.08.006.
- Background: PubMed 20716567Grocott MP, Pearse RM. Prognostic studies of perioperative risk: robust methodology is needed. Br J Anaesth. 2010 Sep;105(3):243-5. doi: 10.1093/bja/aeq207. No abstract available.
- Background: PubMed 21999306Mamidanna R, Almoudaris AM, Faiz O. Is 30-day mortality an appropriate measure of risk in elderly patients undergoing elective colorectal resection? Colorectal Dis. 2012 Oct;14(10):1175-82. doi: 10.1111/j.1463-1318.2011.02859.x.
- Background: PubMed 20305437Faiz O, Brown T, Bottle A, Burns EM, Darzi AW, Aylin P. Impact of hospital institutional volume on postoperative mortality after major emergency colorectal surgery in English National Health Service Trusts, 2001 to 2005. Dis Colon Rectum. 2010 Apr;53(4):393-401. doi: 10.1007/DCR.0b013e3181cc6fd2.
- Background: PubMed 20412094Faiz O, Haji A, Bottle A, Clark SK, Darzi AW, Aylin P. Elective colonic surgery for cancer in the elderly: an investigation into postoperative mortality in English NHS hospitals between 1996 and 2007. Colorectal Dis. 2011 Jul;13(7):779-85. doi: 10.1111/j.1463-1318.2010.02290.x. Epub 2010 Apr 19.
- Background: PubMed 20510798Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
- Background: PubMed 22178483Tan KY, Kawamura YJ, Tokomitsu A, Tang T. Assessment for frailty is useful for predicting morbidity in elderly patients undergoing colorectal cancer resection whose comorbidities are already optimized. Am J Surg. 2012 Aug;204(2):139-43. doi: 10.1016/j.amjsurg.2011.08.012. Epub 2011 Dec 16.
- Background: PubMed 21378017Sundermann S, Dademasch A, Rastan A, Praetorius J, Rodriguez H, Walther T, Mohr FW, Falk V. One-year follow-up of patients undergoing elective cardiac surgery assessed with the Comprehensive Assessment of Frailty test and its simplified form. Interact Cardiovasc Thorac Surg. 2011 Aug;13(2):119-23; discussion 123. doi: 10.1510/icvts.2010.251884. Epub 2011 Mar 4.
- Background: PubMed 21890098Robinson TN, Wu DS, Stiegmann GV, Moss M. Frailty predicts increased hospital and six-month healthcare cost following colorectal surgery in older adults. Am J Surg. 2011 Nov;202(5):511-4. doi: 10.1016/j.amjsurg.2011.06.017. Epub 2011 Sep 3.
- Background: PubMed 21976704Pearse RM, Holt PJ, Grocott MP. Managing perioperative risk in patients undergoing elective non-cardiac surgery. BMJ. 2011 Oct 5;343:d5759. doi: 10.1136/bmj.d5759. No abstract available.
- Background: PubMed 21925410Jack S, West M, Grocott MP. Perioperative exercise training in elderly subjects. Best Pract Res Clin Anaesthesiol. 2011 Sep;25(3):461-72. doi: 10.1016/j.bpa.2011.07.003.
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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.
Nigel M Bagnall, MBChB MRCS principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Disorders and Surgery, run by Imperial College London at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Nigel M Bagnall, MBChB MRCS (+44(0)7881448854, nbagnall@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Up to 1 Year Postoperatively). 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 NCT01924585, which also lists 14 linked publications.
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 26 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.