Rectal CancerQUALIPRONCT03292289
Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction
A study testing Pre- and post-operative consultation, Stomatherapy consultation and Questionnaires in people with Rectal Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Pre- and post-operative consultation, Stomatherapy consultation and Questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2018to 29 Jul 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old
- Patients who are going to undergo a proctectomy for a rectal cancer (situated at a distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity reconstruction (using direct, latero-terminal or colonic J-pouch anastomosis)
- Already underwent or not a neoadjuvant radio-chemotherapy
- Affiliation to the National Social Security System
- With informed and signed consent
Who cannot join
- Unwilling patients
- Patient deprived of their liberty or under guardianship or tutorship.
- Abdominal perineal amputation
- No stoma placement planned
- Tumor more than 15 cm from the anal margin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer
This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.
Read the detailed description
First of all, an information document will be given to the patients and their consent will be collected. Then, they will be registered through the online eCRF (or by FAX) and a study number will be given to each patient.
The study will proceed with 2 stomatherapy consultations at one and six months after coloanal continuity reconstruction. Patient care and following up will proceed as usual. The stomatherapy consultation will be done by a qualified nurse.
Before the 1st intervention (proctectomy):
- Collect of clinical data and disease history
- Quality of life questionnaires (EORTC-QLQ-C30 and CR29)
- Evaluation of LARS score
After the 1st intervention (proctectomy, at month 1):
- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL
Before the 2nd intervention (coloanal continuity reconstruction):
- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL
After the 2nd intervention (at month 1, month 3, month 6 and one year):
- at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of postoperative complications
- Quality of life : EORTC-QLC30 and CR-29 questionnaires and LARS score
- Conditions
- Rectal Cancer
- Being tested
- Pre- and post-operative consultation, Stomatherapy consultation, Questionnaires
- Keywords
- proctectomy, coloanal continuity reconstruction
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre- and post-operative consultationProcedure or surgery
Before and between the two interventions
Stomatherapy consultationProcedure or surgery
Clinical exam. At one and six months after the 2nd intervention
QuestionnairesProcedure or surgery
- QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention)
- Stoma-QoL before and after the 2nd intervention
- LARS score at 1, 3, 6 and 12 months after the 2nd intervention
| Study group | Role | What they receive |
|---|---|---|
| Study process | Experimental | Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires Receives: Procedure: Pre- and post-operative consultation; Procedure: Stomatherapy consultation; Procedure: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life 1 year after the second intervention, using LARS score
Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")
Measured: from baseline to 1 year after the second intervention
Secondary outcomes (9)
Quality of life before the first intervention and after the second intervention
Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")
Measured: from baseline to one year after the 2nd intervention
Quality of life using EORTC-QLQ-C30
Assess the quality of life using EORTC-QLQ-C30 questionnaires before the first intervention, between the first and the second intervention and after the second intervention
Measured: from baseline to one year after the 2nd intervention
Quality of life using EORTC-QLQ-CR29 questionnaires
Assess the quality of life using EORTC-QLQ- CR29 questionnaires before the first intervention, between the first and the second intervention and after the second intervention
Measured: from baseline to one year after the 2nd intervention
Impact of stomy on quality of life
Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire
Measured: from the first intervention to 6 months after the first intervention
Rate of patients with anastomotic fistula
Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction
Measured: from the first intervention to 6 months after the first intervention
Surgical complications description
Describe surgical complications linked to the coloanal continuity reconstruction
Measured: from first intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires
Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
Measured: From the 2nd intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires
Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
Measured: From the 2nd intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using LARS score
Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
Measured: From the 2nd intervention to one year after the 2nd intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start18 Jan 2018
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association, Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Pascale COULON, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292289
- Sponsor's protocol ID
- QUALIPRO-1703
- Other IDs
- 2017-A01406-47
- Acronym
- QUALIPRO
- Status last verified
- Mar 2026
- First submitted
- 18 Sep 2017
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT03292289
- Acronym / sponsor ID
- QUALIPRO / QUALIPRO-1703
- Conditions
- Rectal Cancer
- Keywords
- proctectomy, coloanal continuity reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Santelys Association, Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 25 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.
This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.
Detailed description
First of all, an information document will be given to the patients and their consent will be collected. Then, they will be registered through the online eCRF (or by FAX) and a study number will be given to each patient.
The study will proceed with 2 stomatherapy consultations at one and six months after coloanal continuity reconstruction. Patient care and following up will proceed as usual. The stomatherapy consultation will be done by a qualified nurse.
Before the 1st intervention (proctectomy):
- Collect of clinical data and disease history
- Quality of life questionnaires (EORTC-QLQ-C30 and CR29)
- Evaluation of LARS score
After the 1st intervention (proctectomy, at month 1):
- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL
Before the 2nd intervention (coloanal continuity reconstruction):
- Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL
After the 2nd intervention (at month 1, month 3, month 6 and one year):
- at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of postoperative complications
- Quality of life : EORTC-QLC30 and CR-29 questionnaires and LARS score
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study process | Experimental | Procedure: Pre- and post-operative consultation, Procedure: Stomatherapy consultation, Procedure: QuestionnairesPre- and post-operative consultations. Stomatherapy consultation. Questionnaires |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 70 years old
- Patients who are going to undergo a proctectomy for a rectal cancer (situated at a distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity reconstruction (using direct, latero-terminal or colonic J-pouch anastomosis)
- Already underwent or not a neoadjuvant radio-chemotherapy
- Affiliation to the National Social Security System
- With informed and signed consent
Key exclusion criteria (5 listed)
- Unwilling patients
- Patient deprived of their liberty or under guardianship or tutorship.
- Abdominal perineal amputation
- No stoma placement planned
- Tumor more than 15 cm from the anal margin
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 |
|---|---|---|
| Pre- and post-operative consultationBefore and between the two interventions | Procedure or surgery | Study process |
| Stomatherapy consultationClinical exam. At one and six months after the 2nd intervention | Procedure or surgery | Study process |
| Questionnaires* QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention) * Stoma-QoL before and after the 2nd intervention * LARS score at 1, 3, 6 and 12 months after the 2nd intervention | Procedure or surgery | Study process |
Primary outcome
Quality of life 1 year after the second intervention, using LARS score
Time frame: from baseline to 1 year after the second intervention
Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")
9 secondary outcomes
Quality of life before the first intervention and after the second intervention
Time frame: from baseline to one year after the 2nd intervention
Quality of life using EORTC-QLQ-C30
Time frame: from baseline to one year after the 2nd intervention
Quality of life using EORTC-QLQ-CR29 questionnaires
Time frame: from baseline to one year after the 2nd intervention
Impact of stomy on quality of life
Time frame: from the first intervention to 6 months after the first intervention
Rate of patients with anastomotic fistula
Time frame: from the first intervention to 6 months after the first intervention
Surgical complications description
Time frame: from first intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires
Time frame: From the 2nd intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires
Time frame: From the 2nd intervention to one year after the 2nd intervention
Quality of life of patients with a second stoma placement, using LARS score
Time frame: From the 2nd intervention to one year after the 2nd intervention
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 17 Mar 2026.
- 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.
Pascale COULON study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre- and post-operative consultation, Stomatherapy consultation and Questionnaires in people with Rectal Cancer, run by Centre Oscar Lambret 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 5 inclusion and 5 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 17 Mar 2026. 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?
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?
Quality of life 1 year after the second intervention, using LARS score (time frame: from baseline to 1 year after the second intervention). 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 17 Mar 2026.