EORTC QLQ-C30: central generic questionnaire associated with different disease specific modules
EORTC QLQ-OG25: module to assess the quality of life in patients with esophagogastric disease.
GIQLI: Gastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale.
SWAL QoL: Swallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia.
Videofluoroscopy: It consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia.
Study summary
The goal of this prospective population-based cohort study is to assess:
* The evolution of the functional status of patients undergoing complex esophageal reconstruction
* Its impact on quality of life, depending on the type of conduit performed.
Participants
* Will be asked to complete different quality of life questionnaires during every follow-up visit
* Will undergo additional tests to assess functionality
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adult patients (≥ 18 years of age) and of both gender.
* Candidates for complete esophageal reconstruction with cervical anastomosis, regardless of the etiology of the esophagectomy.
* Decision to indicate a coloplasty (+/- supercharged) or jejunoplasty (free, pedunculated +/- supercharged) as surgical technique after evaluation by the UREC Committee.
* Acceptance to participate in the study and comply with the program of procedures (schedule of visits).
* Signing of the informed consent.
Exclusion Criteria:
* Patients who withdraw their informed consent at any time during the course of the study.
Primary outcome measure(s)
Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire. — The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out. This study aims to determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged) using the following questionnaires:
* European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30): All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
* European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25): All of the scales and single-item measures range in score from 0 to 100. A high score for all the scales and single-items represents a high level of symptomatology or problems.
* Gastrointestinal quality of life index (GIQLI): scale range from 0-144
* Swallowing quality of life questionnaire (SWAL QoL): scale range from 0-100
Number (percentage) of patients who present tolerance to the oral intake and need (volume in milliliters) of enteral nutrition depending on the type of conduit. — The follow-up of each patient included in the study will end 3 years after the intervention when the End of Study visit will be carried out. This study aims to describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
Trial sites (1)
Facility
City
Region
Status
Hospital Uversitari de Bellvitge
Barcelona
Spain
Recruiting
More Hospital Universitari de Bellvitge trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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