Clinical trial NCT03292289: Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction
Official title: Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: proctectomy
coloanal continuity reconstruction
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Santelys Association
name: Groupement Interrégional de Recherche Clinique et d'Innovation
First posted: 2017-09-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of life 1 year after the second intervention, using LARS score
timeFrame: from baseline to 1 year after the second intervention
Secondary outcomes:
measure: Quality of life before the first intervention and after the second intervention
timeFrame: from baseline to one year after the 2nd intervention
measure: Quality of life using EORTC-QLQ-C30
timeFrame: from baseline to one year after the 2nd intervention
measure: Quality of life using EORTC-QLQ-CR29 questionnaires
timeFrame: from baseline to one year after the 2nd intervention
measure: Impact of stomy on quality of life
timeFrame: from the first intervention to 6 months after the first intervention
measure: Rate of patients with anastomotic fistula
timeFrame: from the first intervention to 6 months after the first intervention
measure: Surgical complications description
timeFrame: from first intervention to one year after the 2nd intervention
measure: Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires
timeFrame: From the 2nd intervention to one year after the 2nd intervention
measure: Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires
timeFrame: From the 2nd intervention to one year after the 2nd intervention
measure: Quality of life of patients with a second stoma placement, using LARS score
timeFrame: From the 2nd intervention to one year after the 2nd intervention
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Pascale COULON
role: STUDY_DIRECTOR
References: