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

Quality of Life Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

-General Justification: In recent years, esophageal reconstruction has been a great surgical challenge for the multidisciplinary teams in charge of carrying out this complex technique, associated with high morbidity and a high impact on the quality of life and functional status of patients.

One of the most important aspects of this surgery is the type of conduit used to restore digestive transit. Classically, gastroplasty has been the technique of choice due to its lower morbidity and mortality and less surgical complexity. On the other hand, in those patients in whom the stomach is not available, a coloplasty or a jejunoplasty is chosen, both of which can be associated with supercharged techniques to improve and ensure good vascular flow.

Currently, there is controversy about which type of conduit to use in the absence of a viable stomach. Since the introduction of microvascular or supercharged techniques, the postoperative results of jejunal grafts are comparable to coloplasty and even gastroplasty according to some authors.

The present study is an initiative of the Complex Esophageal Reconstruction Unit (UREC) of Bellvitge University Hospital (HUB), which aims to compare the different types of conduit used in complex esophageal reconstruction, assessing, in the short and long term, the postoperative functional status and its impact on quality of life through validated test-type tools, as well as carrying out complementary tests that allow evaluating aspects such as swallowing and dysphagia, among others.

• Hypothesis Considering the results of quality of life and functionality in the short and long term, jejunoplasty (free, pedunculated ± supercharged) could be the second technique of choice to perform in the absence of gastric conduit in complex esophageal reconstruction.

• Primary objective:

1. To determine the differences in the quality of life of patients undergoing complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).

2. To describe the functional evolution of complex esophageal reconstruction by jejunoplasty (free, pedunculated ± supercharged) or coloplasty (± supercharged).

• Study design CEREC-2022 is a prospective population-based cohort study that aims to assess the evolution of the functional status of patients undergoing complex esophageal reconstruction and its impact on quality of life, depending on the type of conduit performed.

• 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.

• Main Outcome

1. Quality of life related to the swallowing function based on the conduit: it will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ C30), European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Oesophago Gastric module 25 (EORTC QLQ OG25), Gastrointestinal quality of life index (GIQLI) and Swallowing quality of life questionnaire (SWAL QoL)

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.

• Secondary outcome Incidence of dysphagia evaluated by Videofluoroscopy (VDF), Incidence of stenosis of the conduit in the Upper Digestive Endoscopy (UDE), Number (percentage) of dilatations of the conduit, Number (percentage) of patients with esophagitis according to the Los Angeles classification, Nutritional status, Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group, Number of hospitalizations.

• As this is an observational study of a low-prevalent surgical indication, it is expected to include all patients scheduled for surgery from September 2022 to September 2025.

• 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. ;

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Quality of Life

• NCT number: NCT05802459
• Study type: Observational [Patient Registry]
• Source: Hospital Universitari de Bellvitge
• Contact: Monica Miró
• Phone: +34932607500
• Email: mmiro@bellvitgehospital.cat
• Status: Recruiting
• Start date: December 15, 2022
• Completion date: September 2027