Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05802459
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2023-03-07
Brief Title:
Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life CEREC
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Hospital Universitari de Bellvitge
Study Overview
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
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEREC
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None