Rectal CancerNCT02190656
Anterior Resection Syndrome Following Sphincter-preserving Surgery
An observational study of Rectal Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Bowel cancer is the third most common cancer in the UK in both males and females. The rectum is the most commonly affected part of the bowel. Improvements in surgery have meant that many patients with rectal cancer can now undergo surgery that removes the rectum and avoids a permanent stoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 1,197 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery
Who may be able to join
- Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery
- Patients who are more than 12 months post reversal of any defunctioning stoma
- Aged over 18 years
Who cannot join
- Any inclusion criteria not met
- Presence of a stoma
- Local recurrence of cancer
- Current adjuvant therapy
- Further rectal surgery after the initial operation
- Insufficient written English to participate
Trial locations and contacts
1 site in 1 country.
About this study
Bowel cancer is the third most common cancer in the UK in both males and females. The rectum is the most commonly affected part of the bowel. Improvements in surgery have meant that many patients with rectal cancer can now undergo surgery that removes the rectum and avoids a permanent stoma. The operation that most patients have is an anterior resection of the rectum.
Unfortunately this surgery frequently leads to a change in bowel function, with patients suffering from incontinence, urgency and unpredictability a problem known as anterior resection syndrome. These problems are believed to be fairly common following surgery but follow up appointments have traditionally concentrated on ensuring that the cancer has not returned and have not reviewed functional outcomes in enough detail. Because of this we are unsure exactly how common the problems described are.
The proposed study will allow us to determine how many patients have ongoing symptoms following their surgery for rectal cancer. It will also allow us to use a newly developed scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK population, to ensure that it can accurately be used in the future to measure the problem and aid development of new therapies. An appreciation of the impact of symptoms on postoperative quality of life will encourage routine assessment of functional outcomes in clinical practice, allowing identification of patients who may benefit from treatment.
Read the detailed description
One of the main aims when carrying out surgery for rectal cancer is to avoid patients ending up with a permanent stoma. The current standard operation for resection of the rectum is an anterior resection. A large proportion of the patients undergoing this procedure develop anterior resection syndrome, with significant alteration of their bowel habit, including urgency, incontinence and unpredictability. Many definitions for this problem have been used and until recently there was no specifically designed tool for measuring it. There has never been a large scale study in the UK to tell us how common the problem is. A meta-analysis combining results from small studies show marked variation in the frequency of symptoms ranging from 285%, mainly because of the different methods of assessment used in the studies.
The LARS score was recently developed by a research group in Denmark. Their results show that 45.9% of patients had major LARS at 12 months following surgery. This is nearly half of all patients in their sample and clearly represents an important problem.
Anterior resection syndrome is known to have a negative effect on quality of life. It is a multifactorial condition and is increased in patients have chemotherapy and radiotherapy. There are treatments available and also in development which may help patients. However in clinical practice, patients are not routinely asked about their functional outcome and the effect that these symptoms can have on patients' lives is often not discussed. The urgent need for further research into the longterm functional effects of treatments for cancer has been acknowledged by the National Institute for Health and Care Excellence (NICE) and the National Cancer Survivorship Initiative.
Determining baseline prevalence in the UK and validating the LARS score will allow accurate preoperative counselling of patients about functional outcomes following surgery for rectal cancer. It will facilitate comparison between populations, further helping to determine risk factors and aiding in development of therapeutic interventions. An appreciation of the impact of anterior resection syndrome on postoperative quality of life will encourage routine assessment of functional outcomes in clinical practice, allowing identification of patients who may benefit from treatment.
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Anterior Resection Syndrome, Functional outcomes
- Medical subject headings
- Rectal 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 |
|---|---|---|
| Anterior resection | Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with no LARS; minor LARS and major LARS
This will allow us to determine the prevalence of Low Anterior Resection Syndrome
Measured: At the time of questionnaire completion
Secondary outcomes (1)
Correlation between LARS score and EORTC QLQ-C30 questionnaire score
The association between the LARS score and The European Organization for Research and Treatment of Cancer (EORTC) generic quality of life questionnaire QLQC30 will be used to establish validity of the LARS score. Ability of the score to differ between patient groups known to differ in postoperative function (for example, those who have had radiotherapy and those who have not) will also be used to assess validity.
Measured: At the time of questionnaire completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of 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
- Time perspective
- Cross-sectional
- Enrolment
- 1,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Surgeons of England
- Responsible party
- Sponsor
- Investigators
- Mohamed Thaha, PhD FRCS, Study chair, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190656
- Sponsor's protocol ID
- 009515
- Status last verified
- Apr 2016
- First submitted
- 12 Mar 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Resection Syndrome Following Sphincter-preserving Surgery
- ClinicalTrials.gov ID
- NCT02190656
- Acronym / sponsor ID
- 009515
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Anterior Resection Syndrome, Functional outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,197 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- The Royal College of Surgeons of England
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Jul 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.
Bowel cancer is the third most common cancer in the UK in both males and females. The rectum is the most commonly affected part of the bowel. Improvements in surgery have meant that many patients with rectal cancer can now undergo surgery that removes the rectum and avoids a permanent stoma. The operation that most patients have is an anterior resection of the rectum.
Unfortunately this surgery frequently leads to a change in bowel function, with patients suffering from incontinence, urgency and unpredictability a problem known as anterior resection syndrome. These problems are believed to be fairly common following surgery but follow up appointments have traditionally concentrated on ensuring that the cancer has not returned and have not reviewed functional outcomes in enough detail. Because of this we are unsure exactly how common the problems described are.
The proposed study will allow us to determine how many patients have ongoing symptoms following their surgery for rectal cancer. It will also allow us to use a newly developed scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK population, to ensure that it can accurately be used in the future to measure the problem and aid development of new therapies. An appreciation of the impact of symptoms on postoperative quality of life will encourage routine assessment of functional outcomes in clinical practice, allowing identification of patients who may benefit from treatment.
Detailed description
One of the main aims when carrying out surgery for rectal cancer is to avoid patients ending up with a permanent stoma. The current standard operation for resection of the rectum is an anterior resection. A large proportion of the patients undergoing this procedure develop anterior resection syndrome, with significant alteration of their bowel habit, including urgency, incontinence and unpredictability. Many definitions for this problem have been used and until recently there was no specifically designed tool for measuring it. There has never been a large scale study in the UK to tell us how common the problem is. A meta-analysis combining results from small studies show marked variation in the frequency of symptoms ranging from 285%, mainly because of the different methods of assessment used in the studies.
The LARS score was recently developed by a research group in Denmark. Their results show that 45.9% of patients had major LARS at 12 months following surgery. This is nearly half of all patients in their sample and clearly represents an important problem.
Anterior resection syndrome is known to have a negative effect on quality of life. It is a multifactorial condition and is increased in patients have chemotherapy and radiotherapy. There are treatments available and also in development which may help patients. However in clinical practice, patients are not routinely asked about their functional outcome and the effect that these symptoms can have on patients' lives is often not discussed. The urgent need for further research into the longterm functional effects of treatments for cancer has been acknowledged by the National Institute for Health and Care Excellence (NICE) and the National Cancer Survivorship Initiative.
Determining baseline prevalence in the UK and validating the LARS score will allow accurate preoperative counselling of patients about functional outcomes following surgery for rectal cancer. It will facilitate comparison between populations, further helping to determine risk factors and aiding in development of therapeutic interventions. An appreciation of the impact of anterior resection syndrome on postoperative quality of life will encourage routine assessment of functional outcomes in clinical practice, allowing identification of patients who may benefit from treatment.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior resection | – | –Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery
Key inclusion criteria (3 listed)
- Patients having had an anterior resection for rectal cancer who are more than 12 months post surgery
- Patients who are more than 12 months post reversal of any defunctioning stoma
- Aged over 18 years
Key exclusion criteria (6 listed)
- Any inclusion criteria not met
- Presence of a stoma
- Local recurrence of cancer
- Current adjuvant therapy
- Further rectal surgery after the initial operation
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
Number of participants with no LARS; minor LARS and major LARS
Time frame: At the time of questionnaire completion
This will allow us to determine the prevalence of Low Anterior Resection Syndrome
1 secondary outcome
Correlation between LARS score and EORTC QLQ-C30 questionnaire score
Time frame: At the time of questionnaire completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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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.
Mohamed Thaha, PhD FRCS study chair
Queen Mary University of London
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 Rectal Cancer, run by Queen Mary University of 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with no LARS; minor LARS and major LARS (time frame: At the time of questionnaire completion). 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 5 Apr 2016.