Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires

Pre- and post-operative consultation

Clinical exam. At one and six months after the 2nd intervention

Stomatherapy consultation

* 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

Questionnaires

Pascale COULON

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.

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

Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer

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")

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

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

Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire

Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction

Describe surgical complications linked to the coloanal continuity reconstruction

Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction	NCT03292289	Rectal Cancer	Pre- and post-o... Stomatherapy co... Questionnaires	18 Years - 70 Years	Centre Oscar Lambret
Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction	NCT03292289	Rectal Cancer	Pre- and post-o... Stomatherapy co... Questionnaires	18 Years - 70 Years	Centre Oscar Lambret

Spots Global Cancer Trial Database for coloanal continuity reconstruction