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Идёт набор NCT05802459

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

Наблюдательное Quality of Life Dysphagia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: EORTC QLQ-C30, EORTC QLQ-OG25, GIQLI, SWAL QoL.
Кому может быть актуально
Состояния в реестре: Quality of Life, Dysphagia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

-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.

Вмешательства

  • Другое EORTC QLQ-C30
    central generic questionnaire associated with different disease specific modules
  • Другое EORTC QLQ-OG25
    module to assess the quality of life in patients with esophagogastric disease.
  • Другое GIQLI
    Gastrointestinal Quality of Life Index. It is a gastrointestinal quality of life scale.
  • Другое SWAL QoL
    Swallowing Quality of Life questionnaire. This is a quality of life and quality of attention questionnaire for patients with oropharyngeal dysphagia.
  • Процедура 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.

Первичные конечные точки

  • Quality of life related to the swallowing function assessed using the EORTC QLQ OG25, EORTC QLQ C30, GIQLI and SWAL QoL questionnaire. [Срок оценки: 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. [Срок оценки: 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.]
Вторичные конечные точки (12)
  • Incidence of dysphagia [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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' [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Hospital Uversitari de Bellvitge — Barcelona

Публикации

  • 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

Идентификаторы

NCT: NCT05802459 · CEREC-2022

Первоисточники (государственные реестры)

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