NCT03292289

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Pre- and post-operative consultation	Before and between the two interventions
PROCEDURE	Stomatherapy consultation	Clinical exam. At one and six months after the 2nd intervention
PROCEDURE	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

Timeline

• Start date: 2018-01-18
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2017-09-25
• Last updated: 2026-03-17

Locations

1 site across 1 country: France