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Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

NCT03292289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Santelys Association

    collaborator OTHER

  • Groupement Interrégional de Recherche Clinique et d'Innovation

    collaborator OTHER

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Pascale COULON · Centre Oscar Lambret

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2024-07-29
Completion
2024-07-29

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292289 on ClinicalTrials.gov