RecruitingNCT05802459

Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life (CEREC)

Prospective Evaluation of the Functional Status of Jejunoplasty and Coloplasty in Patients Undergoing Complex Esophageal Reconstruction and Its Impact on Quality of Life (CEREC)


Sponsor

Hospital Universitari de Bellvitge

Enrollment

36 participants

Start Date

Dec 15, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria1

  • Patients who withdraw their informed consent at any time during the course of the study.

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Interventions

OTHEREORTC QLQ-C30

central generic questionnaire associated with different disease specific modules

OTHEREORTC QLQ-OG25

module to assess the quality of life in patients with esophagogastric disease.

OTHERGIQLI

Gastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale.

OTHERSWAL QoL

Swallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia.

PROCEDUREVideofluoroscopy

It consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia.


Locations(1)

Hospital Uversitari de Bellvitge

Barcelona, Spain

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NCT05802459


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