Rectal CancerRectqolNCT03459235
Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.
A study testing quality of life in people with Rectal Cancer and Surgery, run by University Hospital, Caen at 1 site in France.
Trial summary
Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Surgery
- What is being tested?
- quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2018to 15 Jun 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients operated for a rectal adénocarcinoma with a curative aim with or without neo-adjuvating treatment in Calvados between January 1st, 2007 (date of recommendations for clinical practise) and december 31 th, 2014.
- Patients having their main address in the Calvados (at the time of diagnosis) and recorded in the register of digestive tumors of the Calvados.
- patients alive on first of january 2018 without local recurrence nor global recurrence
- patients able to understant a validated questionnaire.
Who cannot join
- Dead patients
- patients with cancer recurrence
- Patient with severe cognitive disorders (confusions) preventing the good understanding of questionnaires.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
François baclesse Center - U1086 - Anticipe
Caen, Normandy, 14000
Yassine Eid, MD, 0033231458625, rectqol@gmail.com
About this study
Official title: Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer Living After 2 Years Without Recurrence. Population Study. (Rectqol)
Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures.
Parallel to the oncological findings, evaluating quality of life and functionnals sequelae has become a priority as highlighted by the second axis of "plan cancer 2014-2019".
Read more
The prevalence of digestive functional sequelae decrease during the first two years after surgery. However, these results are difficult to analyse due to the heterogeneity of used scores in medical litterature. The low anterior resection syndrom associate poly-exoneration, gas and / or stool incontinence, urgency and stool splitting.
The score of low anterior resection " LARS score " validated in Danemark in 2012 allow us to understand the complexity of these sequelae and to measure their impact on the quality of life of patients, that's why he is currently recommended.
In the long term, almost two out of three patients suffer from this syndrom, with half of the patients in a severe form.
However, its prevalence and severity are often underestimated by practitioners. It leads to inappropriate therapeutic measures. The aim of this study is to evaluate the impact of digestive and genito-urinary sequelae on quality of life from validated scores in patients operated curatively of rectal cancer using a population study.
This study should include 676 patients with rectal cancer treated in calvados and alive at 2 years of their proctectomy without local or general recurrence.
- Conditions
- Rectal Cancer, Surgery
- Being tested
- quality of life
- Keywords
- rectal cancer, proctectomy, digestive sequelae, quality of life, Urinary and Sexual sequelae
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of lifeOther
Assessment of the impact of digestive sequelae (LARS score) and genitourinary sequelae (score IPSS, USP, FSFI et IIEF) in Patients With Rectal Cancer using validated questionnaires on quality of life (EORTC QLQ-C30 et QLQ-CR 29).
| Study group | Role | What they receive |
|---|---|---|
| population from registry data | Experimental | the intervention involves completing several quality of life questionnaires validated in the medical literature (LARS score, FSFI, USP, IIEF, IPPS, QLQ C-30, QLQ-CR29) Receives: Other: quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of digestive sequelae in patients operated for a rectal cancer (rectal resection)
score used : LARS score (for men and women). 5 questions about the low anterior resection syndrom. Scale between 0 and 42 points. Better outcome is 0 and worse is 42.
Measured: more than 2 years after rectal resection
assessment of global quality of life in patients operated for a rectal cancer (rectal resection)
Score used : EORTC - QLQ C-30 - European Organization for research and treatment of cancer Quality of Life Questionnaire Core 30 (for men and women). It is a scale to evaluate the generic quality of life after cancer. There are 30 questions : 28 questions with 4 possible answers from 1 to 4 and 2 questions to evaluate the physical state and global quality of life with answers between 1 and 7. For each answer, 1 is the worst outcome and 4 is the best except for the 2 last questions where 7 is the best outcome. Minimum (worst outcome) is 30 and best outcome is 126. The total is reported to a score of 100 points which is the best outcome.
Measured: more than 2 years after rectal resection
assessment of specific quality of life in patients operated for a rectal cancer (rectal resection)
score used : EORTC - QLQ CR 29 European Organization for research and treatment of cancer Quality of Life Questionnaire Colorecatl module 29 (for men and women). This score is used in patients undergoing treatment for colorectal cancer. There are 29 questions with 4 possible answers (between 1 and 4 points). Best outcome is 4 for each question. Worst outcome is 1 for each question. Minimum (worst outcome) is 29 and best outcome is 116. The total is reported to a score of 100 points which is the best outcome.
Measured: more than 2 years after rectal resection
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for women)
score used : Urinary Symptom Profile : USP (for women). This scale is used to evaluate urinary symptoms. 1 question to evaluate stress urinary incontinence (between 0 and 9 points). 9 points is the worts outcome. 7 questions to evaluate overactive bladder symtoms (between 0 points and 21). 21 points is the worst outcome. 3 questions to evaluate low stream symtoms (between 0 and 9 points). 9 points is the worst outcome.
Global score is between 0 and 39 points. 39 points is the worst outcome and 0 points the best outcome.
Measured: more than 2 years after rectal resection
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for men)
score used : International Prostate Score Symptom : IPSS (for men). There are 7 questions with 5 possible answers (between 0 (best outcome) and 5 (worst outcome)). And one additionnal question to evaluate quality of life due to urinary symptom with 7 possible answers from 0 (best outcome) to 6 (worst outcome). for the seven first questions : best outcome is 0 and worst outcome is 35. For the last question 0 is the best and 6 is the worst outcome).
Measured: more than 2 years after rectal resection
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for women)
score used : Female Sexual Functionnal index : FSFI (for women). 19 questions on sexual sequelae in this questionnaire. Worst outcome is 2 and best outcome is 95 points.
Measured: more than 2 years after rectal resection
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for men)
score used : International Index for Erectile Function 5 : IIEF 5 (for men). 5 questions for sexual quality of life in males. Each questions have 5 answers. 5 points is the best outcome for each question. Minimal score is 1 and best score (best outcome) is 25.
Measured: more than 2 years after rectal resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start20 Mar 2018
- Primary completion15 Apr 2018
- Study completion15 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459235
- Sponsor's protocol ID
- 2017 - A02645-48
- Acronym
- Rectqol
- Status last verified
- Mar 2018
- First submitted
- 22 Dec 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alves A. [Recommendations for clinical practice. Therapeutic choices for rectal cancer. How can we reduce therapeutic sequelae and preserve quality of life?]. Gastroenterol Clin Biol. 2007 Jan;31 Spec No 1:1S52-62, 1S95-7. No abstract available. French.
PubMed 17569477Abdelli A, Tillou X, Alves A, Menahem B. Genito-urinary sequelae after carcinological rectal resection: What to tell patients in 2017. J Visc Surg. 2017 Apr;154(2):93-104. doi: 10.1016/j.jviscsurg.2016.10.002. Epub 2017 Feb 1.
PubMed 28161008Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
PubMed 22504191Eid Y, Bouvier V, Menahem B, Thobie A, Dolet N, Finochi M, Renier M, Gardy J, Launoy G, Dejardin O, Morello R, Alves A; Rectqol Group. Digestive and genitourinary sequelae in rectal cancer survivors and their impact on health-related quality of life: Outcome of a high-resolution population-based study. Surgery. 2019 Sep;166(3):327-335. doi: 10.1016/j.surg.2019.04.007. Epub 2019 Jun 14.
PubMed 31204071
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer Living After 2 Years Without Recurrence. Population Study. (Rectqol)
- ClinicalTrials.gov ID
- NCT03459235
- Acronym / sponsor ID
- Rectqol / 2017 - A02645-48
- Conditions
- Rectal Cancer, Surgery
- Keywords
- rectal cancer, proctectomy, digestive sequelae, quality of life, Urinary and Sexual sequelae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Jun 2018 (estimated)
- First posted
- 8 Mar 2018 (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.
Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures.
Parallel to the oncological findings, evaluating quality of life and functionnals sequelae has become a priority as highlighted by the second axis of "plan cancer 2014-2019".
The prevalence of digestive functional sequelae decrease during the first two years after surgery. However, these results are difficult to analyse due to the heterogeneity of used scores in medical litterature. The low anterior resection syndrom associate poly-exoneration, gas and / or stool incontinence, urgency and stool splitting.
The score of low anterior resection " LARS score " validated in Danemark in 2012 allow us to understand the complexity of these sequelae and to measure their impact on the quality of life of patients, that's why he is currently recommended.
In the long term, almost two out of three patients suffer from this syndrom, with half of the patients in a severe form.
However, its prevalence and severity are often underestimated by practitioners. It leads to inappropriate therapeutic measures. The aim of this study is to evaluate the impact of digestive and genito-urinary sequelae on quality of life from validated scores in patients operated curatively of rectal cancer using a population study.
This study should include 676 patients with rectal cancer treated in calvados and alive at 2 years of their proctectomy without local or general recurrence.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| population from registry data | Experimental | Other: quality of lifethe intervention involves completing several quality of life questionnaires validated in the medical literature (LARS score, FSFI, USP, IIEF, IPPS, QLQ C-30, QLQ-CR29) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients operated for a rectal adénocarcinoma with a curative aim with or without neo-adjuvating treatment in Calvados between January 1st, 2007 (date of recommendations for clinical practise) and december 31 th, 2014.
- Patients having their main address in the Calvados (at the time of diagnosis) and recorded in the register of digestive tumors of the Calvados.
- patients alive on first of january 2018 without local recurrence nor global recurrence
- patients able to understant a validated questionnaire.
Key exclusion criteria (3 listed)
- Dead patients
- patients with cancer recurrence
- Patient with severe cognitive disorders (confusions) preventing the good understanding of questionnaires.
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 |
|---|---|---|
| quality of lifeAssessment of the impact of digestive sequelae (LARS score) and genitourinary sequelae (score IPSS, USP, FSFI et IIEF) in Patients With Rectal Cancer using validated questionnaires on quality of life (EORTC QLQ-C30 et QLQ-CR 29). | Other | population from registry data |
Primary outcome
assessment of digestive sequelae in patients operated for a rectal cancer (rectal resection)
Time frame: more than 2 years after rectal resection
score used : LARS score (for men and women). 5 questions about the low anterior resection syndrom. Scale between 0 and 42 points. Better outcome is 0 and worse is 42.
assessment of global quality of life in patients operated for a rectal cancer (rectal resection)
Time frame: more than 2 years after rectal resection
Score used : EORTC - QLQ C-30 - European Organization for research and treatment of cancer Quality of Life Questionnaire Core 30 (for men and women). It is a scale to evaluate the generic quality of life after cancer. There are 30 questions : 28 questions with 4 possible answers from 1 to 4 and 2 questions to evaluate the physical state and global quality of life with answers between 1 and 7. For each answer, 1 is the worst outcome and 4 is the best except for the 2 last questions where 7 is the best outcome. Minimum (worst outcome) is 30 and best outcome is 126. The total is reported to a score of 100 points which is the best outcome.
assessment of specific quality of life in patients operated for a rectal cancer (rectal resection)
Time frame: more than 2 years after rectal resection
score used : EORTC - QLQ CR 29 European Organization for research and treatment of cancer Quality of Life Questionnaire Colorecatl module 29 (for men and women). This score is used in patients undergoing treatment for colorectal cancer. There are 29 questions with 4 possible answers (between 1 and 4 points). Best outcome is 4 for each question. Worst outcome is 1 for each question. Minimum (worst outcome) is 29 and best outcome is 116. The total is reported to a score of 100 points which is the best outcome.
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for women)
Time frame: more than 2 years after rectal resection
score used : Urinary Symptom Profile : USP (for women). This scale is used to evaluate urinary symptoms. 1 question to evaluate stress urinary incontinence (between 0 and 9 points). 9 points is the worts outcome. 7 questions to evaluate overactive bladder symtoms (between 0 points and 21). 21 points is the worst outcome. 3 questions to evaluate low stream symtoms (between 0 and 9 points). 9 points is the worst outcome. Global score is between 0 and 39 points. 39 points is the worst outcome and 0 points the best outcome.
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for men)
Time frame: more than 2 years after rectal resection
score used : International Prostate Score Symptom : IPSS (for men). There are 7 questions with 5 possible answers (between 0 (best outcome) and 5 (worst outcome)). And one additionnal question to evaluate quality of life due to urinary symptom with 7 possible answers from 0 (best outcome) to 6 (worst outcome). for the seven first questions : best outcome is 0 and worst outcome is 35. For the last question 0 is the best and 6 is the worst outcome).
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for women)
Time frame: more than 2 years after rectal resection
score used : Female Sexual Functionnal index : FSFI (for women). 19 questions on sexual sequelae in this questionnaire. Worst outcome is 2 and best outcome is 95 points.
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for men)
Time frame: more than 2 years after rectal resection
score used : International Index for Erectile Function 5 : IIEF 5 (for men). 5 questions for sexual quality of life in males. Each questions have 5 answers. 5 points is the best outcome for each question. Minimal score is 1 and best score (best outcome) is 25.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Results publication: PubMed 17569477Alves A. [Recommendations for clinical practice. Therapeutic choices for rectal cancer. How can we reduce therapeutic sequelae and preserve quality of life?]. Gastroenterol Clin Biol. 2007 Jan;31 Spec No 1:1S52-62, 1S95-7. No abstract available. French.
- Results publication: PubMed 28161008Abdelli A, Tillou X, Alves A, Menahem B. Genito-urinary sequelae after carcinological rectal resection: What to tell patients in 2017. J Visc Surg. 2017 Apr;154(2):93-104. doi: 10.1016/j.jviscsurg.2016.10.002. Epub 2017 Feb 1.
- Results publication: PubMed 22504191Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
- Derived from this study: PubMed 31204071Eid Y, Bouvier V, Menahem B, Thobie A, Dolet N, Finochi M, Renier M, Gardy J, Launoy G, Dejardin O, Morello R, Alves A; Rectqol Group. Digestive and genitourinary sequelae in rectal cancer survivors and their impact on health-related quality of life: Outcome of a high-resolution population-based study. Surgery. 2019 Sep;166(3):327-335. doi: 10.1016/j.surg.2019.04.007. Epub 2019 Jun 14.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality of life in people with Rectal Cancer and Surgery, run by University Hospital, Caen at 1 site in France.
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 4 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 18 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 France. 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 Arnaud Alves, MD, PhD (0033231063106, alves-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of digestive sequelae in patients operated for a rectal cancer (rectal resection) (time frame: more than 2 years after rectal resection). The study lists 7 primary outcomes in all. 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 NCT03459235, which also lists 4 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 18 May 2018.