Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life (CEREC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients who withdraw their informed consent at any time during the course of the study.
Trial population
The target population of this study is made up of patients who are candidates for complex esophageal reconstruction performed by the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB), during the study period. All patients who are candidates for complete replacement of the esophagus through reconstruction are presented to the Committee of the Complex Esophageal Reconstruction Functional Unit of the Bellvitge University Hospital (UREC-HUB). After the multidisciplinary assessment, the most appropriate type of surgery for each patient is proposed and the patient receives the information during a scheduled appointment, at this moment the patient is asked to participate in the CEREC-2022 study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
EORTC QLQ-C30
Other interventioncentral generic questionnaire associated with different disease specific modules
EORTC QLQ-OG25
Other interventionmodule to assess the quality of life in patients with esophagogastric disease.
GIQLI
Other interventionGastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale.
SWAL QoL
Other interventionSwallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia.
Videofluoroscopy
Procedure/SurgeryIt consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Patients undergoing complex esophageal reconstruction5 interventions
Trial outcomes
Primary outcomes
1
Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire.
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
Time frame
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.2
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.
This study aims to describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).
Time frame
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.Secondary outcomes
1
Incidence of dysphagia
Incidence of dysphagia evaluated by Videofluoroscopic (VDF) using the following scales: * Videofluoroscopic dysphagia scale (VDS) * Dysphagia outcome and severity scale(DOSS) * Penetration-aspiration scale(PAS)
Time frame
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.2
Incidence of stenosis of the conduit
Incidence of stenosis of the conduit in the Upper Digestive Endoscopy (UDE) that requires some therapeutic maneuver (dilatation), which is carried out during the follow-up visits: one year, two and three years.
Time frame
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.3
Number (percentage) of dilatations of the conduit
Number (percentage) of dilatations of the conduit, per patient, carried out during the UDE within the follow-up visits: one year, two and three years.
Time frame
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.4
Number (percentage) of patients with esophagitis
Number (percentage) of patients with esophagitis according to the Los Angeles classification evidenced in any of the UDE performed during the follow-up visits: one year, two and three years.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov