Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction (QUALIPRO)

Centre Oscar Lambret

Status: Active, not recruiting

Conditions: Rectal Cancer

Treatments: Procedure: Stomatherapy consultation; Procedure: Questionnaires; Procedure: Pre- and post-operative consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT03292289

2017-A01406-47 (Other Identifier)

QUALIPRO-1703

Details and patient eligibility

About

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.

Full 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

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

65 participants in 1 patient group

Study process

Experimental group

Description:

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

Treatment:

Procedure: Pre- and post-operative consultation

Procedure: Questionnaires

Procedure: Stomatherapy consultation