Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life (CEREC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EORTC QLQ-C30, EORTC QLQ-OG25, GIQLI, SWAL QoL.
- Who it may be relevant to
- Registry conditions: Quality of Life, Dysphagia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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
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.
Interventions
- Other EORTC QLQ-C30
central generic questionnaire associated with different disease specific modules - Other EORTC QLQ-OG25
module to assess the quality of life in patients with esophagogastric disease. - Other GIQLI
Gastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale. - Other SWAL QoL
Swallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia. - Procedure Videofluoroscopy
It consists of 14 items that represent the oral and pharyngeal function observed in the VDF. It allows to quantify the severity of dysphagia.
Primary outcome measures
- Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire. [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.]
- 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. [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 outcome measures (12)
- Incidence of dysphagia [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.]
- Incidence of stenosis of the conduit [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.]
- Number (percentage) of dilatations of the conduit [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.]
- Number (percentage) of patients with esophagitis [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.]
- Number (percentage) of patients with chronic diarrhea [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.]
- Body Mass Index [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.]
- Muscle strength measured by Handgrip strength (HGS) dynamometer [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.]
- Serum albumin value [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.]
- Mean 'time of need for enteral nutrition and oral nutrition supplements' [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.]
- Volume of enteral nutrition required [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.]
- Number of hospitalizations [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.]
- Number (percentage) of specific complications of the surgery during admission according to the Esophageal Complication Consensus Group (ECCG) [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.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Patients who withdraw their informed consent at any time during the course of the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Uversitari de Bellvitge — Barcelona
Publications
- Bothereau H, Munoz-Bongrand N, Lambert B, Montemagno S, Cattan P, Sarfati E. Esophageal reconstruction after caustic injury: is there still a place for right coloplasty? Am J Surg. 2007 Jun;193(6):660-4. doi: 10.1016/j.amjsurg.2006.08.074. PMID 17512272
- Farran-Teixido L, Miro-Martin M, Biondo S, Conde-Mourino R, Bettonica-Larranaga C, Aranda Danso H, Sans-Segarra M, Rafecas-Renau A. [Second time esophageal reconstruction surgery: coloplasty and gastroplasty]. Cir Esp. 2008 May;83(5):242-6. doi: 10.1016/s0009-739x(08)70561-x. Spanish. PMID 18448026
- Irino T, Tsekrekos A, Coppola A, Scandavini CM, Shetye A, Lundell L, Rouvelas I. Long-term functional outcomes after replacement of the esophagus with gastric, colonic, or jejunal conduits: a systematic literature review. Dis Esophagus. 2017 Dec 1;30(12):1-11. doi: 10.1093/dote/dox083. PMID 28881882
- Jacobs M, Macefield RC, Elbers RG, Sitnikova K, Korfage IJ, Smets EM, Henselmans I, van Berge Henegouwen MI, de Haes JC, Blazeby JM, Sprangers MA. Meta-analysis shows clinically relevant and long-lasting deterioration in health-related quality of life after esophageal cancer surgery. Qual Life Res. 2014 May;23(4):1097-115. doi: 10.1007/s11136-013-0545-z. Epub 2013 Oct 16. PMID 24129668
- Miro M, Farran L, Estremiana F, Miquel J, Escalante E, Aranda H, Bettonica C, Galan M. Does gastric conditioning decrease the incidence of cervical oesophagogastric anastomotic leakage? Cir Esp (Engl Ed). 2018 Feb;96(2):102-108. doi: 10.1016/j.ciresp.2017.11.012. Epub 2018 Feb 17. English, Spanish. PMID 29459004
- Lamas S, Azuara D, de Oca J, Sans M, Farran L, Alba E, Escalante E, Rafecas A. Time course of necrosis/apoptosis and neovascularization during experimental gastric conditioning. Dis Esophagus. 2008;21(4):370-6. doi: 10.1111/j.1442-2050.2007.00772.x. PMID 18477261
- Farran Teixidor L, Vinals Vinals JM, Miro Martin M, Higueras Sune C, Bettonica Larranaga C, Aranda Danso H, Lopez Ojeda A, Rafecas Renau A. [Supercharged ileocoloplasty: an option for complex oesophageal reconstructions]. Cir Esp. 2011 Feb;89(2):87-93. doi: 10.1016/j.ciresp.2010.10.009. Epub 2011 Feb 1. Spanish. PMID 21277572
- Ochsner A, Owens N. Anterothoracic Oesophagoplasty for Impermeable Stricture of the Oesophagus. Ann Surg. 1934 Dec;100(6):1055-91. doi: 10.1097/00000658-193412000-00002. No abstract available. PMID 17856421
Identifiers
NCT: NCT05802459 · CEREC-2022