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

NCT05802459 | Recruiting

• 1 other identifier: CEREC-2022
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Quality of Life; Dysphagia

Keywords

Esophageal reconstruction; Quality of life; Coloplasty; Jejunoplasty; Dysphagia

Outcome Measures

Primary Outcomes (2)

• 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

  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.

• 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).

  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 (13)

• Incidence of dysphagia

  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.

• Incidence of stenosis of the 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.

• Number (percentage) of dilatations of the 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.

• Number (percentage) of patients with esophagitis

  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.

• Number (percentage) of patients with chronic diarrhea

  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.

Study Arms (1)

Patients undergoing complex esophageal reconstruction

All the 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.

Other: EORTC QLQ-C30; Other: EORTC QLQ-OG25; Other: GIQLI; Other: SWAL QoL; Procedure: Videofluoroscopy

Interventions

EORTC QLQ-C30 OTHER

central generic questionnaire associated with different disease specific modules

Patients undergoing complex esophageal reconstruction

EORTC QLQ-OG25 OTHER

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

Patients undergoing complex esophageal reconstruction

GIQLI OTHER

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

Patients undergoing complex esophageal reconstruction

SWAL QoL OTHER

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

Patients undergoing complex esophageal reconstruction

Videofluoroscopy PROCEDURE

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

Patients undergoing complex esophageal reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Uversitari de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Leandre Farran

  Bellvitge University Hospital

  STUDY DIRECTOR

Central Study Contacts

Monica Miró

CONTACT

+34932607500; mmiro@bellvitgehospital.cat

Rodrigo Hermoza

CONTACT

+34932607500; rhermoza@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate surgeon and specialist in Upper Gastrointestinal surgery. PhD, MD.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 6, 2023
• Study Start: December 15, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

ES (1)